EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists), HER4 antagonists(Receptor protein-tyrosine kinase erbB-4 antagonists)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesNervous System Diseases+ [3]

Active Indication

Early Stage Breast CarcinomaHormone receptor positive breast cancerBreast Cancer+ [25]

Inactive Indication

Advanced HER2-Positive Breast CarcinomaAdvanced Lung Non-Small Cell CarcinomaChronic liver disease+ [12]

Originator Organization

Pfizer Inc.

Active Organization

Puma Biotechnology, Inc.Zhejiang Fukang Pharmaceutical Co., Ltd.Bixink, Inc.

+ [8]

Inactive Organization

Pfizer Inc.Wyeth Research

Jiangsu Aosaikang Pharmaceutical Co. Ltd.

Drug Highest PhaseApproved

First Approval Date

United States (17 Jul 2017),

HER2-negative breast cancer

RegulationFast Track (United States), Orphan Drug (United States)

Structure/Sequence

Molecular FormulaC34H33ClN6O7

InChIKeyVXZCUHNJXSIJIM-MEBGWEOYSA-N

CAS Registry915942-22-2

115

Clinical Trials associated with Neratinib maleate

NCT06813079

/ Not yet recruitingPhase 2IIT

ADOPT: Adaptive Organoid-Based Precision Therapy Study in Pancreatic Cancer - A Prospective Single-Arm Phase II Trial

The purpose of this study is to see if using Patient Derived Organoids (PDO) to choose a drug for the treatment of pancreatic cancer individually for each patient is useful. The study will look at the number of participants who have a response to their assigned drug.

Start Date17 Feb 2025

Sponsor / Collaborator

University Health Network

NCT05919108

/ RecruitingPhase 2IIT

Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers

This phase II trial tests how well neratinib prior to the primary treatment (neoadjuvant) works in treating patients with stage I-III HER2 mutated lobular breast cancers. Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving neratinib in addition to normal therapy may work better in treating cancer than the endocrine therapy patients would normally receive.

Start Date31 Jan 2025

Sponsor / Collaborator

The Vanderbilt-Ingram Cancer Center

[+2]

CTR20244703

/ CompletedNot Applicable

马来酸奈拉替尼片（40mg）在中国健康受试者中餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of neratinib maleate tablets (40 mg) in healthy Chinese subjects after administration of the drug after a meal

主要研究目的：按有关生物等效性试验的规定，选择Excella GmbH & Co.KG生产的马来酸奈拉替尼片（商品名：贺俪安®，规格：40mg）为参比制剂，对湖南科伦制药有限公司生产并提供的受试制剂马来酸奈拉替尼片（规格：40mg）进行餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂马来酸奈拉替尼片（规格：40mg）和参比制剂马来酸奈拉替尼片（商品名：贺俪安®，规格：40mg）的安全性。

[Translation]

Main purpose of the study: According to the relevant provisions of bioequivalence tests, the neratinib maleate tablets (trade name: Helian®, specification: 40 mg) produced by Excella GmbH & Co.KG were selected as the reference preparation, and the human bioequivalence test of the test preparation neratinib maleate tablets (specification: 40 mg) produced and provided by Hunan Kelun Pharmaceutical Co., Ltd. was conducted to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under postprandial administration conditions. Secondary purpose of the study: To observe the safety of oral administration of the test preparation neratinib maleate tablets (specification: 40 mg) and the reference preparation neratinib maleate tablets (trade name: Helian®, specification: 40 mg) by healthy volunteers.

Start Date07 Jan 2025

Sponsor / Collaborator

Hunan Kelun Pharmaceutical Co., Ltd.

100 Clinical Results associated with Neratinib maleate

100 Translational Medicine associated with Neratinib maleate

100 Patents (Medical) associated with Neratinib maleate

1,027

Literatures (Medical) associated with Neratinib maleate

01 Apr 2025·MOLECULAR DIVERSITY

Targeting AFP-RARβ complex formation: a potential strategy for treating AFP-positive hepatocellular carcinoma

Article

Author: Dev, Radul R ; Soman, Sowmya ; Banjan, Bhavya ; Raju, Rajesh ; Vishwakarma, Riya ; Rehman, Niyas ; Kalath, Haritha ; Kumar, Pankaj ; Revikumar, Amjesh ; Abhinand, Chandran S ; Ramakrishnan, Krishnapriya

Alpha-fetoprotein (AFP) is a glycoprotein primarily expressed during embryogenesis, with declining levels postnatally. Elevated AFP levels correlate with pathological conditions such as liver fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). Recent investigations underscore AFP's intracellular role in HCC progression, wherein it forms complexes with proteins like Phosphatase and tensin homolog (PTEN), Caspase 3 (CASP3), and Retinoic acid receptors and Retinoid X receptors (RAR/RXR). RAR and RXR regulate gene expression linked to cell death and tumorigenesis in normal physiology. AFP impedes RAR/RXR dimerization, nuclear translocation, and function, promoting gene expression favoring cancer progression in HCC that provoked us to target AFP as a drug candidate. Despite extensive studies, inhibitors targeting AFP to disrupt complex formation and activities remain scarce. In this study, employing protein-protein docking, amino acid residues involved in AFP-RARβ interaction were identified, guiding the definition of AFP's active site for potential inhibitor screening. Currently, kinase inhibitors play a significant role in cancer treatment and, the present study explores the potential of repurposing FDA-approved protein kinase inhibitors to target AFP. Molecular docking with kinase inhibitors revealed Lapatinib as a candidate drug of the AFP-RARβ complex. Molecular dynamics simulations and binding energy calculations, employing Mechanic/Poisson-Boltzmann Surface Area (MM-PBSA), confirmed Lapatinib's stability with AFP. The study suggests Lapatinib's potential in disrupting the AFP-RARβ complex, providing a promising avenue for treating molecularly stratified AFP-positive HCC or its early stages.

01 Mar 2025·BIOORGANIC & MEDICINAL CHEMISTRY LETTERS

Neratinib derivative 7A induces apoptosis in colon cancer cells via the p53 pathway

Article

Author: Ji, Jing ; Zhou, Ying ; Zhang, Xing-Yu ; Wang, Xiu-Jun ; Sun, Qian ; Liu, Ruo-Tong ; Ye, Xiao-Qing ; Cheng, Wen-Hao ; Zhou, Chun-Yun ; Liu, Zhi-Yu ; Zhang, Bo-Yu

Colorectal cancer remains a significant health threat, with its incidence continuously rising, underscoring the urgent need for the development of new therapeutic agents. In our previous research, we identified 7A, a derivative of Neratinib, as having pronounced antitumor activity. However, its specific effects and mechanisms in colorectal cancer have not been thoroughly investigated. Therefore, this study employed in vivo and in vitro experiments, utilizing techniques such as RNA sequencing, Western blotting, and PCR, to provide a comprehensive analysis of 7A's mechanism of action in colorectal cancer. The results indicate that 7A induces DNA damage and activates the P53 pathway, thereby promoting apoptosis in colorectal cancer cells. Additionally, 7A treatment significantly reduced angiogenesis and tumor weight. Our findings suggest that 7A, a Neratinib derivative, holds promise as a novel candidate for colorectal cancer therapy.

28 Feb 2025·JOURNAL OF MICROBIOLOGY

Small molecule kinase inhibitor altiratinib inhibits brain cyst forming bradyzoites of Toxoplasma gondii

Article

Author: Kim, Yeong Hoon ; Nam, Ho-Woo ; Ahn, Hye-Jin ; Kim, Hwa Sun

Chronic toxoplasmosis is caused by Toxoplasma gondii bradyzoites. This study assessed six candidate small molecule kinase inhibitors (SMKIs) against bradyzoites (ME49 strain), the reactivated form of the parasite resulting from the rupture of brain cysts. Bradyzoites were obtained from mouse brain cysts, cultured in ARPE-19 cells, and treated with afatinib and neratinib (HER2/HER4 inhibitors), ACTB-1003 and regorafenib (VEGFR-2 inhibitors), or altiratinib and foretinib (c-MET inhibitors). The effects on the growth of T. gondii were analyzed by western blot and immunofluorescence assay. Changes in the host cells were assessed using markers for cell viability, apoptosis, necrosis, and autophagy. All inhibitors blocked the growth of bradyzoites, although afatinib was less effective. Afatinib enhanced autophagy signals, while ACTB-1003 and neratinib affected mitochondrial biosynthesis and mitophagy. Altiratinib demonstrated an effect against bradyzoites at the lowest concentration with minimal impact on the host cells. It may be effective in blocking the reactivation of brain cysts in immunodeficiency patients caused by bradyzoites.

139

News (Medical) associated with Neratinib maleate

24 Mar 2025

·www.prnewswire.com

Henlius 2024 Annual Results: Steady Revenue Growth with a Net Profit of RMB820.5 million, Up by 50.3% YoY

SHANGHAI, March 24, 2025 /PRNewswire/ -- Henlius (2696.HK) announced its 2024 annual results. During the reporting period, Henlius' total revenue reached approximately RMB5.7244 billion, representing an increase of 6.1% YoY. The net profit reached RMB820.5 million, a 50.3% YoY growth, with a net profit margin of 14.3%, up by 41.6% YoY. This marks Henlius' second consecutive year of full-year profitability following its first profitable year in 2023. The increasing commercial sales of core products have been a key driver of profitability, with total product sales revenue reaching approximately RMB4.9335 billion, an increase of 8.3% YoY. Additionally, the company's annual R&D expenditure reached RMB1.8405 billion, representing an increase of 28.4% YoY. Henlius has accelerated breakthroughs in its innovation pipeline and efficiently expanded its global footprint, unlocking further growth potential and driving sustainable, high-quality development. Up to date, Henlius has secured approvals for 6 products in China and 4 internationally, reaching over 50 countries and regions across Asia, Europe, Latin America, North America, and Oceania, benefiting over 750,000 patients worldwide. During the reporting period, the company completed 25 marketing applications and secured 17 approvals around the world, covering key markets such as China, the United States (U.S.), the European Union (EU), Canada and Indonesia, accelerating its global expansion. Additionally, Henlius has maintained a differentiated innovation strategy, building a pipeline of about 50 molecules, including monoclonal antibodies (mAbs), polyclonal antibodies (pAbs), antibody-drug conjugates (ADCs), and fusion proteins. The company leverages cutting-edge technologies such as AI to address unmet clinical needs and enhance the translation of innovative achievements. Mr. Wenjie Zhang, Chairman of Henlius, said: "Henlius has consistently achieved year-round profit growth, which fully validates our continuous improvement in strategic planning and business operational efficiency, laying a solid foundation for sustainable development. Adhering to patient-centricity, Henlius will continue to focus on unmet clinical needs, fully leverage the advantages of its integrated platform, further optimize the lean operation management system, and drive the company towards higher quality development." Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said: "Over the past year, we have anchored our strategy in innovation and globalization, accelerating overseas market expansion and solidifying our position as a leader among Chinese biopharmaceutical companies going global. By building a diversified innovation pipeline and embracing cutting-edge technologies, we have consistently fuelled innovation and unlocked sustainable growth momentum. Moving forward, we will continue to be driven by innovation, advancing our global journey to deliver more high-quality treatment options for patients worldwide." Harnessing Momentum through Profitability, Charting New Horizons in Global Expansion In 2024, Henlius continued to deepen its focus on high-incidence cancer areas such as breast cancer, lung cancer, and gastrointestinal tumours, with core products driving steady revenue growth and achieving the goal of sustained profitability. During the reporting period, Henlius' 6 products recorded total sales revenue of RMB4.9335 billion, up by 8.3% YoY. Among these, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), HANBEITAI (bevacizumab) and HANNAIJIA (neratinib), achieved sales revenues of RMB2.8100 billion, RMB1.3126 billion, RMB197.1 million and RMB45.3 million, respectively in 2024. Additionally, based on agreements with partners, the company received total revenues of RMB550.4 million and RMB40.1 million for HANLIKANG (rituximab) and HANDAYUAN (adalimumab), respectively. The company's core product on breast cancer, HANQUYOU, maintained robust growth. In 2024, the global sales revenue of HANQUYOU was approximately RMB2.8100 billion, with domestic sales of RMB2.6924 billion and overseas sales revenue of RMB117.6 million up by 27.0% YoY. HANQUYOU is a China-developed monoclonal antibody biosimilar receiving approvals in China, the U.S., and Europe, making it the most widely approved Chinese mAb biosimilar across multiple countries and regions. In 2024, the product received approvals for marketing in countries and regions including the Philippines, Brazil, the U.S., and Canada, with successful shipments made to Saudi Arabia and the U.S. Its commercial supply network now covers countries and regions such as China, Southeast Asia, North America, Europe, the Middle East, and Latin America. To date, HANQUYOU has gained marketing approvals in over 50 countries and regions, including the U.S., the U.K., Canada, France, Germany, Switzerland and has been included in the national medical insurance catalogues of countries such as China, the UK, France, and Germany, benefiting over 240,000 patients globally. Additionally, in August 2024, Henlius entered into a strategic cooperation with Convalife Pharmaceuticals for HANNAIJIA (neratinib), an oral small molecule anti-tumour drug, further enriching its breast cancer treatment portfolio. Neratinib is used for extended adjuvant therapy in early-stage HER2-positive breast cancer and can be used sequentially with HANQUYOU to further reduce the risk of recurrence for patients with early-stage HER2-positive breast cancer within 5 and 10 years after surgery, providing a new treatment option for patients. Focusing on lung cancer and gastrointestinal tumours, HANSIZHUANG, recognized for its breakthrough efficacy and differentiated advantages, has been approved for marketing in over 30 countries and regions, including China, Europe and Southeast Asia, benefiting more than 100,000 patients. In 2024, HANSIZHUANG recorded a total sales revenue of RMB1.3126 billion, representing an increase of 17.2% YoY, with domestic sales of RMB1.3089 billion. HANSIZHUANG is the world's first anti-PD-1 mAb approved for the first-line treatment of small cell lung cancer. In December 2024, it was approved for the treatment of non-squamous non-small cell lung cancer (nsNSCLC), marking its third approved indication in lung cancer following squamous NSCLC and extensive-stage small cell lung cancer (ES-SCLC). Furthermore, HANSIZHUANG has been included in 118 provincial/city-level commercial medical insurance programs across China, further strengthening its market competitiveness. In terms of overseas expansion, the company continues to collaborate with partners including Intas, KGbio, and Fosun Pharma to promote the globalization of HANSIZHUANG. To date, HANSIZHUANG has been licensed out to more than 100 countries and regions including the U.S., Europe, Southeast Asia, the Middle East, and North Africa. In the first quarter of 2024, the company efficiently completed the first shipment of HANSIZHUANG overseas, marking its entry as the first domestically produced anti-PD-1 mAb in Southeast Asian countries, offering new treatment options to patients worldwide. In February 2025, it was approved in the EU for the first-line ES-SCLC treatment, becoming the first and currently the only anti-PD-1 mAb in the EU for this indication, further benefiting more patients worldwide. In 2024, as part of its commitment to provide affordable and high-quality biomedicines for patients worldwide, Henlius has achieved remarkable success in the international market, and successfully realized the "Closed-loop Internationalization 1.0". Following HANQUYOU and HANSIZHUANG, China's first biosimilar, HANLIKANG, was approved for marketing in several Latin American countries including Peru, while HANBEITAI received its first approval in Bolivia, becoming Henlius' fourth product approved overseas. Moreover, the marketing applications for HLX14 (denosumab biosimilar) have been accepted in both the EU and the U.S., and the marketing applications for HLX11 (pertuzumab biosimilar) have also been accepted in China and the U.S., infusing new momentum into the company's global development. In 2024, the company achieved new milestones in business collaborations. Henlius has expanded its collaborations in emerging markets with Getz for HANQUYOU and with Abbott for five biopharmaceuticals. It has also entered into an out-licensing partnership with Dr. Reddy's for HLX15, a biosimilar of daratumumab, accelerating the global expansion of the product. Besides, the company partnered with Sermonix on HLX78 (lasofoxifene), an investigational novel endocrine therapy for breast cancer, for the Asian region, and collaborated with Palleon to advance glycan-editing therapies, further enhancing its pipeline. Additionally, the company established a strategic partnership with SVAX to set up a joint venture in Saudi Arabia, enhancing the accessibility of advanced biologics across the Middle East, North Africa, and Türkiye (MENAT) countries. Deepening Innovation Pipeline to Address Unmet Clinical Needs In 2024, Henlius focused on unmet clinical needs, driving innovation in antibody technology to accelerate the development of potential "First-in-Class" and "Best-in-Class" molecules into clinical stages. The company optimized its ADC and T cell Engager (TCE) platforms, leveraging advanced technologies such as AI to enhance R&D capabilities. In clinical development, Henlius actively progressed the development of HANSIZHUANG, HLX22 (anti-HER2 mAb), HLX43 (PD-L1 ADC) and other products. The company has initiated a range of clinical trials to support global regulatory submissions for a wide variety of indications for HANSIZHUANG. The phase 3 stage of the international multi-centre clinical trial (ASTRUM-015) of serplulimab in combination with bevacizumab and chemotherapy in first-line treatment of metastatic colorectal cancer (mCRC) has dosed the first patients in China, Indonesia and Japan, potentially making it the first anti-PD-1 mAb in non-MSI-H mCRC worldwide. The company is actively advancing an international multi-centre phase 3 clinical trial of HANSIZHUANG plus chemotherapy and concurrent radiotherapy in patients with limited-stage small cell lung cancer (LS-SCLC) and a phase 3 clinical trial of HANSIZHUANG plus chemotherapy as neoadjuvant/adjuvant therapy for gastric cancer (GC). Henlius is also conducting a bridging head-to-head trial in the U.S. to compare HANSIZHUANG with standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC. HLX22, targeting HER2-positive advanced gastric cancer, received Phase 3 clinical trial approvals from China NMPA, U.S. FDA, Japan PMDA, Australia TGA etc., and this international study has been initiated in multiple countries and regions worldwide and has completed its first patient dosing globally. In March 2025, the U.S. FDA granted orphan drug designation (ODD) to HLX22 for the treatment of gastric cancer. A phase 2 trial is also evaluating the potential of HLX22 in other HER2-expressing solid tumours in combination with trastuzumab and chemotherapy or in combination with trastuzumab deruxtecan (T-DXd). HLX43, the world's second and China's first clinical-stage PD-L1 ADC, has completed its first phase 2 clinical trial dosing in solid tumours. In addition, a phase 1b/2 trial of HLX43 in combination with the anti-PD-1 mAb serplulimab has been approved in China, aiming to exploit the synergistic effects of ADC and immunotherapy in advanced/metastatic solid tumours. Meanwhile, the company continues to optimize its production operations and quality management system, strengthening its foundation for future development. To date, it has established a total commercial capacity of 48,000 litres, ensuring stable supply to countries and regions including China, Southeast Asia, North America, Europe, the Middle East, and Latin America. The completion of the Songjiang Second Plant will further enhance its production capabilities. In terms of quality management, the company's manufacturing facilities and production lines have successfully passed nearly a hundred inspections or audits conducted by various regulatory authorities and international business partners. It has obtained GMP certifications from China, the EU, the U.S. and multiple PIC/S member countries, including Indonesia and Brazil. Additionally, the Songjiang Facility has received ISO 14001 and ISO 45001 dual certifications, demonstrating its international leadership in environmental sustainability and employee health and safety, further strengthening its company's global production and supply capabilities. Looking forward, Henlius will continue to adhere to its patient-centricity, driven by innovation and globalization, to enhance commercial operations, strengthen production capacity and provide more accessible and affordable high-quality treatment options for patients worldwide, steadily advancing toward becoming a globally competitive biopharmaceutical company. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 4 marketing applications have been accepted for review in China, the U.S. and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world's first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What's more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets. SOURCE Henlius WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalLicense out/inPhase 3Phase 2Immunotherapy

27 Feb 2025

·investor.pumabiotechnology.com

Puma Biotechnology Reports Fourth Quarter and Full Year 2024 Financial Results

LOS ANGELES--(BUSINESS WIRE)-- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced financial results for the fourth quarter and year ended December 31, 2024. Unless otherwise stated, all comparisons are for the fourth quarter and full year 2024 compared to the fourth quarter and full year 2023. Product revenue, net consists entirely of revenue from sales of NERLYNX®, Puma’s first commercial product. Product revenue, net for the fourth quarter of 2024 was $54.4 million, compared to $53.2 million in the fourth quarter of 2023. Product revenue, net for the full year 2024 was $195.2 million, compared to $203.1 million in 2023. Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $19.3 million, or $0.39 per basic and diluted share, for the fourth quarter of 2024, compared to net income of $12.3 million, or $0.26 per basic and diluted share, for the fourth quarter of 2023. Net income for full year 2024 was $30.3 million, or $0.62 per basic and diluted share, compared to net income of $21.6 million, or $0.46 per basic share and $0.45 per diluted share, for full year 2023. The fourth quarter 2024 net income of $19.3 million, or $0.39 per basic and diluted share includes a partial release of our valuation allowance that favorably impacted net income by $7.1 million and favorably impacted earnings per share by $0.15 per basic and diluted share. This compares to net income in the third quarter 2024 of $20.3 million, or $0.41 per basic and diluted share. Non-GAAP adjusted net income was $21.1 million, or $0.43 per basic and diluted share, for the fourth quarter of 2024, compared to non-GAAP adjusted net income of $14.8 million, or $0.31 per basic and diluted share, for the fourth quarter of 2023. Non-GAAP adjusted net income for full year 2024 was $38.5 million, or $0.79 per basic and $0.78 per diluted share, compared to non-GAAP adjusted net income of $31.8 million, or $0.68 per basic share and $0.67 per diluted share, for full year 2023. Non-GAAP adjusted net income excludes stock-based compensation expense. For a reconciliation of GAAP net income to non-GAAP adjusted net income and GAAP net income per share to non-GAAP adjusted net income per share, please see the financial tables at the end of this news release. Net cash provided by operating activities for the fourth quarter of 2024 was $15.6 million, compared to net cash provided by operating activities of $10.5 million for the fourth quarter of 2023. Net cash provided by operating activities for full year 2024 was $38.9 million, compared to net cash provided by operating activities of $27.0 million for full year 2023. At December 31, 2024, Puma had cash, cash equivalents, and marketable securities of approximately $101 million, compared to cash, cash equivalents, and marketable securities of $96 million at December 31, 2023. “We are very pleased with our financial results for the fourth quarter of 2024, as well as for the full year 2024, and we are very pleased to be able to report positive net income for the third consecutive year, reflecting our strong execution and disciplined financial management,” said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. “This execution was driven by both our continued commercial performance in the United States and abroad, as well as effective implementation of our planned initiatives to raise patient awareness and expand access channels. In addition, we are pleased to be able to initiate the ALI-1201/ALISCA™-Breast1 Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer in November, which is a significant step in our clinical development plan for alisertib.” Mr. Auerbach added, “We anticipate the following key milestones over the next 12 months: (i) presentation of interim data from the Phase I trial of neratinib given in combination with trastuzumab deruxtecan in solid tumors with HER2 alterations (H1 2025); (ii) presentation of interim data from ALISCA™-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (2025); and (iii) presentation of additional interim data from the ALI-4201/ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (2025). Revenue Total revenue consists of product revenue, net from sales of NERLYNX, license revenue and royalty revenue. For the fourth quarter of 2024, total revenue was $59.1 million, of which $54.4 million was product revenue, net and $4.7 million was royalty revenue. This compares to total revenue of $72.2 million for the fourth quarter of 2023, of which $53.2 million was product revenue, net and $19.0 million was royalty revenue. For the year ended December 31, 2024, total revenue was $230.5 million, of which $195.2 million was product revenue, net and $35.3 million was royalty revenue. This compares to total revenue in 2023 of $235.6 million, of which $203.1 million was product revenue, net and $32.5 million was royalty revenue. Puma reported no license revenue for the years ended December 31, 2024 and 2023. Operating Costs and Expenses Total operating costs and expenses were $45.7 million for the fourth quarter of 2024, compared to $57.4 million for the fourth quarter of 2023. Total operating costs and expenses were $199.5 million for full year 2024, compared to $203.0 million for full year 2023. Cost of Sales Cost of sales was $13.9 million for the fourth quarter of 2024, compared to $24.3 million for the fourth quarter of 2023. Cost of sales was $64.4 million for full year 2024, compared to cost of sales of $62.7 million for full year 2023. The $1.7 million increase in full year 2024 was primarily due to the increase of product unit sales to our sub-licensees and the related cost of sales (primarily sales in China), partially offset by lower domestic sales. Selling, General and Administrative Expenses Selling, general and administrative (SG&A) expenses were $16.6 million for the fourth quarter of 2024, compared to $20.2 million for the fourth quarter of 2023. SG&A expenses for full year 2024 were $80.2 million, compared to $89.9 million for full year 2023. The $9.7 million decrease in SG&A expenses for full year 2024 compared to 2023 resulted primarily from a decrease in professional fees and expenses of approximately $4.1 million, primarily due to a decrease in consultant and contractor expenses (primarily marketing related) of approximately $2.7 million, a decrease in legal fees of approximately $1.0 million, and a decrease in insurance and other expense of approximately $0.4 million; a decrease in payroll and related costs of approximately $1.9 million, primarily due to lower headcount, partially offset by annual salary increases; a decrease in provision for credit loss (recovery) of approximately $1.4 million, due to an overdue receivable as of December 31, 2023 that was collected in 2024; a decrease in stock-based compensation expense of approximately $1.3 million, primarily due to lower fair value on equity grants as a result of a lower market price for our common stock; and a decrease in loss on impairment of asset expense of $0.6 million in connection with our decision to sublease a portion of our leased office space in 2023, which was recorded as an operating asset in accordance with ASC 842. Research and Development Expenses Research and development (R&D) expenses were $15.2 million for the fourth quarter of 2024, compared to $12.9 million for the fourth quarter of 2023. R&D expenses for full year 2024 were $54.9 million, compared to $50.4 million for full year 2023. The $4.5 million increase in R&D expenses during full year 2024 compared to full year 2023 resulted from an increase in clinical trial expense of approximately $3.5 million, primarily due to the procurement of our alisertib drug product, as well as increased alisertib study activity, partially offset by the achievement of fewer clinical milestones; an increase in internal R&D of approximately $1.5 million, primarily due to higher compensation related to achieving company goals and one-time payroll and severance-related expenses; partially offset by a decrease in stock-based compensation of approximately $0.7 million, primarily due to lower fair value on equity grants as a result of a lower market price for our common stock. Total Other Income (Expenses) Total other expenses were $1.1 million for the fourth quarter of 2024, compared to total other expenses of $2.0 million for the fourth quarter of 2023. Total other expenses were $6.9 million for full year 2024, compared to $9.9 million for full year 2023. The $3.0 million decrease in other expenses in full year 2024 resulted primarily from a $2.1 million increase in interest income, which reflected higher balances in cash equivalents and marketable securities, and a $0.9 million decrease in interest expense, which was due to the pay down of debt in 2024, as well as ending imputed interest on $8.0 million related to the final installment payment of the Eshelman litigation settlement paid in October 2024. Deferred Income Tax Benefit In the fourth quarter of 2024, Puma released a portion of its valuation allowance resulting in a non-cash, deferred tax income benefit of $7.1 million. The valuation allowance was established to offset Puma’s deferred tax assets, which are primarily related to its historical losses. This significantly increased Puma’s net income for the fourth quarter and full year 2024. First Quarter 2025 and Full Year 2025 Financial Outlook First Quarter 2025 Full Year 2025 Net Product Revenue $41–$43 million $192–$198 million Royalty Revenue $1.5–$2.5 million $20–$24 million License Revenue $0 million $0 million Net Income/(Loss)* $(2)–$0 million $23–$28 million Gross to Net Adjustment 22.5%–23.5% 20.5%–21.5% *There are no tax valuation allowance adjustments included in the outlook above. Conference Call Puma Biotechnology will host a conference call to report its fourth quarter and full year 2024 financial results and provide an update on Puma’s business and outlook at 1:30 p.m. PT/4:30 p.m. ET on Thursday, February 27, 2025. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the “Puma Biotechnology Conference Call.” A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at https://www.pumabiotechnology.com. A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days. About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral) in 2011. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX® is a registered trademark of Puma Biotechnology, Inc. In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer. In February 2024, Puma initiated ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA™-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR-positive metastatic breast cancer. To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at https://www.NERLYNX.com or by calling 1-855-816-5421. Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com. INDICATIONS NERLYNX® (neratinib) tablets, for oral use, is a kinase inhibitor indicated: As a single agent, for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy. In combination with capecitabine, for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer, who have received two or more prior anti-HER2 based regimens in the metastatic setting. Important Safety Information Regarding NERLYNX® (neratinib) U.S. Indication CONTRAINDICATIONS: None WARNINGS AND PRECAUTIONS: Diarrhea: Manage diarrhea through either NERLYNX dose escalation or loperamide prophylaxis. If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction. Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities. Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ADVERSE REACTIONS : The most common adverse reactions (reported in ≥ 5% of patients) were as follows: NERLYNX as a single agent: Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection. NERLYNX in combination with capecitabine: Diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms. To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . DRUG INTERACTIONS: Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists. Or separate NERLYNX by at least 3 hours with antacids. Strong CYP3A4 inhibitors: Avoid concomitant use. P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant use. Strong or moderate CYP3A4 inducers: Avoid concomitant use. Certain P-gp substrates: Monitor for adverse reactions of P-gp substrates for which minimal concentration change may lead to serious adverse reactions when used concomitantly with NERLYNX. USE IN SPECIFIC POPULATIONS : Lactation: Advise women not to breastfeed. Please see Full Prescribing Information for additional safety information. Forward-Looking Statements This press release contains forward-looking statements, including statements regarding Puma’s anticipated milestones and estimates of future financial results for the first quarter and full year 2025. All forward-looking statements involve risks and uncertainties that could cause Puma’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, any adverse impact on Puma’s business or the global economy and financial markets, any changes in Puma’s product candidates’ regulatory approvals, results from Puma’s clinical trials, any litigation involving Puma, any changes to Puma’s in-licensed intellectual property and the risk factors disclosed in the periodic and current reports filed by Puma with the Securities and Exchange Commission from time to time, including Puma’s Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent filings. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law. 2024 2023 2024 2023 $ 54.4 $ 53.2 195.2 203.1 4.7 19.0 35.3 32.5 59.1 72.2 230.5 235.6 13.9 24.3 64.4 62.7 16.6 20.2 80.2 89.9 15.2 12.9 54.9 50.4 45.7 57.4 199.5 203.0 13.4 14.8 31.0 32.6 1.2 0.7 4.7 2.6 (2.6 ) (3.3 ) (12.5 ) (13.3 ) 0.2 0.6 0.9 0.8 (1.2 ) (2.0 ) (6.9 ) (9.9 ) 12.2 12.8 24.1 22.7 — (0.5 ) (0.9 ) (1.1 ) 7.1 — 7.1 — $ 19.3 $ 12.3 $ 30.3 $ 21.6 $ 0.39 $ 0.26 $ 0.62 $ 0.46 $ 0.39 $ 0.26 $ 0.62 $ 0.45 49,095,583 47,600,505 48,648,701 47,134,331 49,408,877 48,040,118 49,100,433 47,550,852 2024 2023 $ 69.2 $ 84.6 $ 31.7 $ 11.4 $ 51.5 $ 56.8 $ 45.3 $ 34.0 $ 21.7 $ 65.7 $ 92.1 $ 53.4 2024 2023 $ 38.9 $ 27.0 (20.4 ) (19.1 ) (33.9 ) — $ (15.4 ) $ 7.9 Use of Non-GAAP Measures In addition to operating results as calculated in accordance with GAAP, Puma uses certain non-GAAP financial measures when planning, monitoring, and evaluating operational performance. The following table presents Puma’s net income and net income per share calculated in accordance with GAAP and as adjusted to remove the impact of stock-based compensation expense. For the three months and twelve months ended December 31, 2024, stock-based compensation represented approximately 5.5% and 6.1% of total selling, general and administrative expense and research and development expense, respectively, and 7.4% and 7.3% for the same periods in 2023. Puma’s management believes that these non-GAAP financial measures are useful to enhance understanding of Puma’s financial performance, are more indicative of its operational performance, and facilitate a better comparison among fiscal periods. These non-GAAP financial measures are not, and should not be viewed as, substitutes for GAAP reporting measures 2024 2023 $ 19.3 $ 12.3 1.3 1.5 0.5 1.0 $ 21.1 $ 14.8 $ 0.39 $ 0.26 0.04 0.05 $ 0.43 (3) $ 0.31 (3) $ 0.39 $ 0.26 0.04 0.05 $ 0.43 (4) $ 0.31 (4) 2024 2023 $ 30.3 $ 21.6 5.5 6.9 2.7 3.3 $ 38.5 $ 31.8 $ 0.62 $ 0.46 0.17 0.22 $ 0.79 (5) $ 0.68 (5) $ 0.62 $ 0.45 0.16 0.22 $ 0.78 (6) $ 0.67 (6) Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500 info@pumabiotechnology.com ir@pumabiotechnology.com David Schull or Olipriya Das, Russo Partners, +1 212 845 4200 david.schull@russopartnersllc.com olipriya.das@russopartnersllc.com

License out/inDrug ApprovalPhase 2Phase 1Financial Statement

11 Feb 2025

·www.prnewswire.com

New Breast Cancer Therapy to Reduce Risk of Recurrence and Improve Disease-Free Survival Now Approved in Thailand

NERLYNX® (neratinib) has been approved as a single agent for the treatment of early-stage HER2+ breast cancer, and in combination with capecitabine for the treatment of advanced or metastatic HER2+ breast cancer[1] Approval coincides with the first appointment of field force employees, signifying the growth of Specialised Therapeutics in Thailand SINGAPORE, Feb. 11, 2025 /PRNewswire/ -- A NEW breast cancer therapy shown to significantly reduce the risk of cancer recurrence and improve disease-free survival in women is now approved for use in Thailand.[1,2,3] NERLYNX® (neratinib), an oral medication, has been approved by the Thailand Food and Drug Administration (Thailand FDA) as a single agent "for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago."[1] Additionally, NERLYNX has been approved in combination with capecitabine"for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting."[1] In early breast cancer, NERLYNX has been shown to significantly reduce the ongoing risk of recurrence in women positive for human epidermal growth factor receptor 2 (HER2+), with the greatest benefit seen in women who are also hormone-receptor positive (HR+) and who commence therapy within 12 months of completing trastuzumab-based therapy.[2,3] For these women, the five-year risk of recurrence is reduced by up to 42%.[4] In women with advanced or metastatic HER2+ breast cancer, NERLYNX in combination with capecitabine (N+C) was found to significantly improve mean progression free survival (PFS) by 2.2 months over treatment with lapatinib plus capecitabine (L+C).[5] The duration of treatment response was longer for patients administered N+C (8.5 months) versus L+C (5.6 months), while the risk of disease progression or death was reduced by up to 24% among those treated with N+C at a median follow-up of 30 months.[5,6] NERLYNX is being made available in Thailand by independent pharmaceutical company, Specialised Therapeutics (ST), under exclusive license from Puma Biotechnology, Inc. ST Chief Executive Officer, Mr Carlo Montagner, said the approval of NERLYNX in Thailand was an important milestone for the company. "We are proud to have obtained approval of NERLYNX in Thailand for adults with HER2 positive breast cancer. This is a significant milestone for Specialised Therapeutics, but importantly also for women diagnosed with breast cancer in Thailand who will be presented with an opportunity to access a treatment that will help reduce the risk of disease recurrence and improve outcomes, in either the early or advanced stages of their disease." Breast cancer is the most common cancer diagnosed in Thai women, and the second leading cause of cancer mortality in females, behind liver cancer.[7] The incidence of breast cancer in Thailand has been rising at an alarming rate, with the annual age-standardised incidence rate doubling over the past 20 years (from 17.8/100,000 in 1998, to 35.7/100,000 in 2020).[8,9] In 2022, 21,628 Thai women were newly diagnosed with breast cancer, accounting for almost a quarter (23.2%) of all new cancer diagnoses in females.[7] Coinciding with the NERLYNX approval, ST is also pleased to announce the growth of its Thailand office, with new field force members due to join the company in March 2025. "We are extremely excited about the new journey we are undertaking in Thailand," said Mr Montagner. "Hiring our first field force employees, who have an extensive understanding of the local healthcare landscape, enables us to connect with oncologists around the country at the earliest opportunity, ahead of launching NERLYNX and making it available for eligible breast cancer patients as soon as possible. "As we continue to seek approvals for our strong pipeline of specialised medicines and technologies, we remain committed to meeting the needs of patients with rare diseases across Thailand, and making a difference to their lives. We look forward to working with the Thailand FDA and local specialists as we endeavour to provide timely access to these new treatments for the patients that need them." Ends. About NERLYNX NERLYNX (neratinib) is an irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4.[10] It is an oral tablet and works by binding to multiple receptors inside the cancer cell, blocking signals that tell cancer cells to grow and multiply.[11,12] NERLYNX has received approval for the treatment of certain patients with extended adjuvant and/or metastatic HER2-positive breast cancer in more than 40 countries outside the United States (US), including the European Union (EU), China, Latin America, Australia, Canada, and Hong Kong. About HER2-Positive (HER2+) Breast Cancer Approximately 20-25% of breast cancer tumours over-express the HER2 protein. HER2-positive (HER2+) breast cancer is a highly heterogeneous tumour that is often more aggressive than other types of breast cancer and has a poor prognosis, increasing the risk of disease progression and death.[10,13,14] While trastuzumab has helped to improve the survival and prognosis of patients with HER2+ breast cancer, around 20-30% of patients will experience recurrence and metastases after trastuzumab targeted therapy.[14] About the ExteNET Study[2-4,15] The ExteNET trial was a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in patients with early-stage HER2-positive breast cancer. The ExteNET trial randomised 2,840 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomised to receive neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of five years after randomisation. The primary endpoint of the trial was invasive disease-free survival (iDFS). The trial demonstrated that after a median follow up of 5.2 years, treatment with neratinib resulted in a 27% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.73, p = 0.008). The 5-year iDFS rate for the neratinib arm was 90.2%, versus 87.7% for the placebo arm. An additional five-year sub-group analysis demonstrated a 42% reduction in risk of recurrence and 59% reduction in risk of CNS recurrence or death of any cause in women who were HR+ and who had commenced neratinib therapy within 12 months of completing treatment with trastuzumab. The most common adverse reactions (≥ 5%) were diarrhoea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection. About the NALA Study[5,6] The NALA trial was a randomised, active-controlled, Phase III trial investigating the efficacy of neratinib, an irreversible pan-HER tyrosine kinase inhibitor (TKI), plus capecitabine (N+C) against lapatinib, a reversible dual TKI, plus capecitabine (L+C) in patients with centrally confirmed HER2+ metastatic breast cancer who had received two or more prior anti-HER2 based regimens in the metastatic setting. 621 patients were enrolled at 203 sites in 28 countries across Europe, North and South America, Asia, and Australia. The primary outcome measures for the trial were progression-free survival (PFS), and overall survival (OS). Median PFS was 5.6 months for patients who received N+C and 5.5 months for those receiving L+C (hazard ratio = 0.76, p = 0.0059). The PFS rate at 12 months was 29% versus 15%, respectively. Median OS was 21 months for patients receiving N+C, compared to 18.7 months for those receiving L+C (hazard ratio = 0.88, p = 0.2086). The most common adverse reactions of any grade (>5%) in the N+C arm were diarrhoea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, decreased weight, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms. About Specialised Therapeutics Founded in 2007, Specialised Therapeutics is the region's largest independent specialty pharmaceutical company, providing new therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions. The ST mission is to provide specialty therapies where there is an unmet need. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas. ST is a member of the World Orphan Drug Alliance (WODA). Additional information can be found at . References: SOURCE Specialised Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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Approved

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Indication	Country/Location	Organization	Date
Early Stage Breast Carcinoma	Canada	Puma Biotechnology, Inc.	16 Jul 2019
Hormone receptor positive breast cancer	Canada	Puma Biotechnology, Inc.	16 Jul 2019
Breast Cancer	Australia	Specialised Therapeutics Australia Pty Ltd.	15 Mar 2019
HER2 Positive Breast Cancer	European Union	Pierre Fabre Médicament SAS	31 Aug 2018
HER2 Positive Breast Cancer	Iceland	Pierre Fabre Médicament SAS	31 Aug 2018
HER2 Positive Breast Cancer	Liechtenstein	Pierre Fabre Médicament SAS	31 Aug 2018
HER2 Positive Breast Cancer	Norway	Pierre Fabre Médicament SAS	31 Aug 2018
HER2-negative breast cancer	United States	Puma Biotechnology, Inc.	17 Jul 2017

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	United States	Puma Biotechnology, Inc.	29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Japan	Puma Biotechnology, Inc.	29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Argentina	Puma Biotechnology, Inc.	29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Australia	Puma Biotechnology, Inc.	29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Austria	Puma Biotechnology, Inc.	29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Belgium	Puma Biotechnology, Inc.	29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Brazil	Puma Biotechnology, Inc.	29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Canada	Puma Biotechnology, Inc.	29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Czechia	Puma Biotechnology, Inc.	29 Mar 2013
Metastatic human epidermal growth factor 2 positive carcinoma of breast	Phase 3	Denmark	Puma Biotechnology, Inc.	29 Mar 2013

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05491057 (NER-Tree, ESMO2024) Manual	Not Applicable	HER2 Positive Breast Cancer Adjuvant HER2 Positive	250	Neratinib <240 mg	phrgbgrosy(rrnmzlvmjv) = mkfqqavpgk gmvnigndxb (yhgvjioisp ) View more	Positive	16 Sep 2024
NCT06083662 (KCSG AL20-17/KM23, ESMO2024) Manual	Phase 2	HER2 Positive Solid Tumors	32	Neratinib combined with trastuzumab	xqkvsbaowh(mnzbtqemaw) = ltysdhokvv suthgzfqqz (oblxktcjya ) View more	Positive	15 Sep 2024
NCT06083662 (KCSG AL20-17/KM23, ESMO2024) Manual	Phase 2	HER2 Positive Solid Tumors	32	Neratinib combined with trastuzumab (ctDNA below 11.47%)	xqkvsbaowh(mnzbtqemaw) = wdwsemuskv suthgzfqqz (oblxktcjya ) View more	Positive	15 Sep 2024
NCT06029816 (CVL009-2001, NEWS) Manual	Phase 2	Non-Small Cell Lung Cancer EGFR罕见突变	-	CVL009	pvjlbvmtwl(tztssuqmho) = cbtmtondgf krzjghmapw (fumpseehcw ) View more	Positive	02 Jul 2024
NCT06083662 (KCSG AL20-17, ASCO2024) Manual	Phase 2	Advanced Malignant Solid Neoplasm ERBB2 Mutation (Activating)	40	Neratinib 240mg p.o. daily + Trastuzumab biosimilar (Herzuma) every 3 weeks	egavaowyyn(kgcavamshc) = oavtwnblyz bkkuqvyneb (snwriiccsl, 0 - 22.63) View more	Positive	24 May 2024
ASCO2024	Not Applicable	HER2 Positive Cancer Neoadjuvant	43	Neratinib plus Trastuzumab and Docetaxel (N+TDtx)	wusysearaw(wsqtavewzg) = irupgxvkjg btucclclbq (rvxwjjqkdi ) View more	Positive	24 May 2024
ASCO2024	Not Applicable	HER2 Positive Cancer Neoadjuvant	43	Pertuzumab plus Trastuzumab and Docetaxel (PT+Dtx)	wusysearaw(wsqtavewzg) = irzoydeouf btucclclbq (rvxwjjqkdi ) View more	Positive	24 May 2024
NCT01494662 (TBCRC 022, CTgov)	Phase 2	HER2 Positive Breast Cancer \| Brain metastases	140	HKI-272 (Cohort 1)	vjstpmbgjd = wejynzheda qcvfhpjvjk (fmcsyinass, ltxztixjpf - flgxcwhngn) View more	-	22 May 2024
NCT01494662 (TBCRC 022, CTgov)	Phase 2	HER2 Positive Breast Cancer \| Brain metastases	140	Surgical Resection (Cohort 2)	ronhqdwjqe(imhmrqsago) = mrdntmfjif nwkcjozpnk (cjmizyvcgi, jhzfafggwo - cygtdhicyx) View more	-	22 May 2024
NCT04388384 (ELEANOR NIS, ESMO_BC 12024 \| ESMO_BC 22024) Manual	Not Applicable	HER2 Positive Breast Cancer Adjuvant HER2 Positive	286	Neratinib	rzhpdzzuoz(rbofmalgqk) = most common adverse events of any grade in >10% pts were diarrhoea, nausea and fatigue with 81.3%, 22.2%, 19.8% respectively. loivaijpra (vhgjcwdmvl )	Positive	15 May 2024
NCT05491057 (NER-Tree, ESMO_BC2024)	Not Applicable	HER2 Positive Breast Cancer Adjuvant HER2+	250	Neratinib	edatbbwjdg(unaqkhnpdz) = foiewniocw rwvqmomwga (beqiawurfm )	Positive	14 May 2024
NCT05491057 (NER-Tree, ESMO_BC2024)	Not Applicable	HER2 Positive Breast Cancer Adjuvant HER2+	250	Trastuzumab plus pertuzumab	prejyqaxsz(cvtmnbvgwe) = xgstpcrsnc alnpdlqjfz (khueafwgsj )	Positive	14 May 2024
NCT02236000 (NSABP FB-10, Pubmed) Manual	Phase 1/2	HER2 Positive Breast Cancer Second line HER2 Positive	49	T-DM1 + neratinib	xjawpiodab(gdnskwhykm) = bwuvkibgee xjdnecqpoq (yfhzyjfdyn ) View more	Positive	22 Apr 2024
NCT01953926 (SUMMIT, Pubmed) Manual	Phase 2	Metastatic Carcinoma to the Uterine Cervix HER2 mutations	22	Neratinib 240mg/day	ikqyyornte(kruiwvjyvn) = arzrnjcumg yhxzgntrcf (sucwvsryvs, 5.2 - 40.3) View more	Positive	01 Feb 2024

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