A Single-arm, Open-label, Phase II Study to Evaluate Clinical Efficacy, Safety and Pharmacokinetics of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination with Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Japanese Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Evaluate Clinical Efficacy, Safety and Pharmacokinetics of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) in Combination with Chemotherapy (Carboplatin-Etoposide) in Previously Untreated Japanese Patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Start Date31 Mar 2025

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

CTR20250349

/ RecruitingPhase 1/2

一项评估HLX43（抗PD-L1 的ADC）联合斯鲁利单抗（抗PD-1人源化单克隆抗体注射液）在晚期/转移性实体瘤患者中的安全性、耐受性和有效性的Ib/II 期临床研究

[Translation] A Phase Ib/II clinical study evaluating the safety, tolerability and efficacy of HLX43 (anti-PD-L1 ADC) combined with slulizumab (anti-PD-1 humanized monoclonal antibody injection) in patients with advanced/metastatic solid tumors

Ib期（剂量递增阶段）：主要目的：评价HLX43 联合斯鲁利单抗在晚期/转移性实体瘤患者中的安全性和耐受性，确定联合用药中HLX43 的最大耐受剂量（MTD）。次要目的：研究HLX43 的药代动力学（PK）特征及斯鲁利单抗的血药浓度；研究HLX43 及斯鲁利单抗的免疫原性；研究HLX43 联合斯鲁利单抗的潜在疗效；研究HLX43 联合斯鲁利单抗治疗晚期/转移性实体瘤患者的潜在药效学、潜在预测性和耐药性生物标志物。 II 期（剂量拓展阶段）：主要目的：研究不同剂量HLX43 联合斯鲁利单抗治疗晚期非小细胞肺癌（NSCLC）的有效性。次要目的：研究HLX43 联合斯鲁利单抗治疗晚期NSCLC 的安全性和耐受性，确定后续临床试验推荐剂量（RP2/3D）；研究HLX43 在NSCLC 患者体内的PK 特征；研究HLX43 免疫原性；研究HLX43 联合斯鲁利单抗治疗NSCLC 的潜在药效学、潜在预测性和耐药性生物标志物。

[Translation]

Phase Ib (dose escalation phase): Primary objective: To evaluate the safety and tolerability of HLX43 combined with slulizumab in patients with advanced/metastatic solid tumors and determine the maximum tolerated dose (MTD) of HLX43 in combination therapy. Secondary objectives: To study the pharmacokinetic (PK) characteristics of HLX43 and the blood concentration of slulizumab; To study the immunogenicity of HLX43 and slulizumab; To study the potential efficacy of HLX43 combined with slulizumab; To study the potential pharmacodynamics, potential predictive and resistance biomarkers of HLX43 combined with slulizumab in the treatment of patients with advanced/metastatic solid tumors. Phase II (dose expansion phase): Primary objective: To study the effectiveness of different doses of HLX43 combined with slulizumab in the treatment of advanced non-small cell lung cancer (NSCLC). Secondary objectives: To study the safety and tolerability of HLX43 combined with slulizumab in the treatment of advanced NSCLC and determine the recommended dose (RP2/3D) for subsequent clinical trials; to study the PK characteristics of HLX43 in NSCLC patients; to study the immunogenicity of HLX43; to study the potential pharmacodynamics, potential predictive and resistance biomarkers of HLX43 combined with slulizumab in the treatment of NSCLC.

Start Date05 Mar 2025

Sponsor / Collaborator

Shanghai Henlius Biotech, Inc.

[+1]

NCT06850103

/ Not yet recruitingPhase 2IIT

A Phase II Exploratory Multicenter Randomized Controlled Clinical Trial to Evaluate the Effectiveness of Neoadjuvant Short-Course Radiotherapy (SCRT) Followed by CAPEOX Chemotherapy and Serplulimab in Microsatellite Stable (MSS) or Proficient Mismatch Repair (pMMR) Rectal Cancer with Synchronous Oligometastases

Background and Significance:
Colorectal cancer (CRC) ranks as the third most common cancer and the second leading cause of cancer-related deaths globally. Despite improved early screening rates, a significant proportion of newly diagnosed CRC patients present with synchronous metastases, predominantly liver metastases. The concept of oligometastases, introduced by Hellman and Weichselbaum in 1995, describes a transitional state between localized disease and widespread metastases, characterized by limited metastatic lesions (typically 1-5) confined to 1-2 organs.
Current Treatment Landscape:
The management of oligometastatic disease combines local therapeutic approaches (surgery, radiotherapy, radiofrequency ablation) with systemic treatments, aiming to achieve No Evidence of Disease (NED) status. The ESMO guidelines officially categorized metastatic CRC into oligometastatic and widespread metastatic states in 2016, emphasizing the importance of integrated local and systemic treatments for oligometastatic colorectal liver metastases (CRLM).
Treatment Evolution and Challenges:
While the EPOC study established CAPEOX neoadjuvant chemotherapy followed by R0 resection as the standard treatment for initially resectable CRLM, patients with synchronous rectal cancer oligometastases present unique challenges due to complex local anatomy and high local recurrence risks. Although various neoadjuvant approaches, including Total Neoadjuvant Therapy (TNT), have been studied, they have not demonstrated significant long-term survival benefits, primarily because distant metastases impact survival more significantly than local recurrence.
Innovative Approach:
Recent success with Immunotherapy-Based Total Neoadjuvant Therapy (iTNT) in microsatellite stable/proficient mismatch repair (MSS/pMMR) locally advanced rectal cancer has shown promising results. Short-course radiotherapy (SCRT) combined with chemotherapy and immunotherapy has demonstrated superior efficacy trends, attributed to radiation's immune-activating effects on both local and distant tumor microenvironments.
Research Objective:
This project aims to evaluate the effectiveness of iTNT combined with SCRT in MSS/pMMR rectal cancer patients with synchronous oligometastases. The novel approach integrates SCRT with CAPEOX chemotherapy and Serplulimab, potentially improving complete response rates, organ preservation opportunities, and overall treatment efficacy while reducing recurrence risks. This pioneering study represents the first investigation of iTNT in synchronous rectal cancer oligometastases, offering a potentially transformative treatment strategy for this challenging patient population.
Research Innovation:
The study uniquely combines SCRT, CAPEOX chemotherapy, and Serplulimab in a neoadjuvant setting for MSS/pMMR synchronous rectal cancer oligometastases, addressing an unmet clinical need and potentially establishing a new treatment paradigm in this field.

Start Date04 Mar 2025

Sponsor / Collaborator

The First Affiliated Hospital, Zhejiang University Sch of Med

100 Clinical Results associated with Serplulimab

100 Translational Medicine associated with Serplulimab

100 Patents (Medical) associated with Serplulimab

Literatures (Medical) associated with Serplulimab

01 Feb 2025·INTERNATIONAL IMMUNOPHARMACOLOGY

Deep analysis of the trials and major challenges in the first-line treatment for patients with extensive-stage small cell lung cancer

Review

Author: Yin, Xiaoyan ; Zhuang, Lulu ; Wu, Peizhu ; Gao, Ran ; Meng, Xiangjiao

The median overall survival (OS) is approximately 10 months when chemotherapy alone is the first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). The approval of the two PD-L1 inhibitors, atezolizumab and durvalumab, marked the beginning of the immunotherapy era for ES-SCLC. Serplulimab, as the first PD-1 inhibitor to achieve success in the first-line treatment of ES-SCLC, has not only demonstrated significant improvements in patient survival outcomes but also ushered in a new era for PD-1 inhibitors in the treatment of ES-SCLC. Recently, antiangiogenic agents with chemo-immunotherapy have achieved breakthroughs in first-line ES-SCLC treatment. Improving the clinical benefits of individualized treatment for patients with ES-SCLC remains challenging. Challenges include identifying biomarkers for targeted therapy, exploring new treatments, developing new medicines, and classifying SCLC molecular subtypes. This review provides an in-depth analysis of research on first-line ES-SCLC treatment. Additionally, it discusses advances in ES-SCLC treatment.

01 Jan 2025·BIOMEDICINE & PHARMACOTHERAPY

Combined treatment of small cell lung cancer using radiotherapy and immunotherapy: Challenges and updates

Review

Author: Cao, Zhumin ; Tian, Ke ; Wang, Bin ; Jiang, Jinxiu ; Deng, Kai

Currently, chemotherapy remains the standard first- and second-line treatment for small cell lung cancer (SCLC). Research concerning immunotherapy has brought about a remarkable development in the treatment pattern of SCLC. Atirizumab, duvalizumab, atezolizumab, and serplulimab can significantly improve the clinical outcomes of SCLC. Given the rapidly evolving concept that combining immunotherapy with radiotherapy can increase therapeutic effectiveness, clinicians are devoted to further improving local tumor control by integrating immunotherapy with radiotherapy. This paper reviews the research progress in this field to date and explores ways to further enhance the efficacy of this combination therapy. We first discussed that immunotherapy combined with radiotherapy can improve the abscopal effect, progression-free survival, and overall survival rates of SCLC patients. Then, the biomarkers related to the radiation immune microenvironment, such as programmed death ligand-1 (PD-L1), tumor mutational burden (TMB), and the immune function of patients were discussed. Next, we explored the occurrence and underlying mechanisms of immune resistance during radiotherapy implementation. Finally, we clarified that the emerging trend of low-dose radiotherapy help overcome the inhibitory signals that limit T-cell infiltration in the tumor matrix. In summary, considering the rapid development of this field, these combined therapy strategies may have unlimited potential to further improve the efficacy of radiotherapy combined with immunotherapy for patients.

01 Jan 2025·Translational Lung Cancer Research

Efficacy and safety of first-line immunotherapy-based regimens for patients with extensive-stage small cell lung cancer: a systematic review and network meta-analysis

Article

Author: Zhao, Lishu ; Zhang, Xinyu ; Wang, Hao ; Chen, Zhimin ; Ye, Li ; Guo, Zhiyi ; Liu, Xinyue ; Liu, Yujin ; He, Yayi ; Zhao, Wencheng ; Zhang, Wengang ; Xu, Kandi

Background:

Combination regimens of immunotherapy plus chemotherapy have been approved as the first-line and standard of care for extensive-stage small cell lung cancer (ES-SCLC). Novel regimens are continuously being explored, with the ETER701 study being the representative randomized controlled trial (RCT). ETER701 study has assessed the efficacy and safety of chemotherapy with or without anlotinib (multi-target angiogenesis inhibitor) + benmelstobart (programmed cell death ligand 1 inhibitor) (Anl/Ben/CT). There is no evidence-based medicine available proving that Anl/Ben/CT is the optimal regimen due to the lack of direct or indirect comparisons among varying immunotherapy-based regimens. In this study, we aimed to identify the optimal regimen to assist in clinical decision-making.

Methods:

The eligible RCTs were identified by searching PubMed, Embase, Cochrane Library databases, and major international conferences. Then, the network meta-analysis was analyzed to compare the efficacy and safety among 15 first-line regimens in ES-SCLC. The Cochrane Risk of Bias Tool was used to assess the risk of bias in included studies.

Results:

A total of 12 immunotherapy-related RCTs covering 15 interventions and 6,178 patients with ES-SCLC were included. Overall, most RCTs exhibited a low risk of bias across multiple domains. The results indicated that most immunotherapy-based regimens could significantly prolong progression-free survival (PFS) compared with chemotherapy alone, especially Anl/Ben/CT [hazard ratio (HR) 0.32, 95% confidence interval (CI): 0.25-0.40]. Similar results were observed regarding overall survival (OS), that is, most immunotherapy-related regimens dramatically reduced the risk of death in ES-SCLC, with Anl/Ben/CT being the most prominent (HR 0.61, 95% CI: 0.47-0.80). The Bayesian ranking probabilities showed that Anl/Ben/CT ranked first and serplulimab plus chemotherapy ranked second in both PFS and OS among 15 regimens. Regarding safety, Anl/Ben/CT ranked 3rd, and serplulimab plus chemotherapy ranked 7th.

Conclusions:

Adding anlotinib and benmelstobart to chemotherapy significantly improved PFS and OS compared with chemotherapy alone or chemotherapy plus immunotherapy, with an acceptable safety profile in patients with ES-SCLC. In conclusion, Anl/Ben/CT could be a new, preferable first-line treatment option but further clinical studies are needed to validate its efficacy and safety.

News (Medical) associated with Serplulimab

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

23 Mar 2025

·www.prnewswire.com

Everest Medicines Announces FDA Clearance of IND Application for Tumor-Associated Antigen Vaccine EVM14

EVM14 received U.S. FDA clearance for its IND application, becoming Everest's first internally discovered program, and the first mRNA therapeutic cancer vaccine to be cleared for global clinical development. Preclinical highlights： EVM14 induced a dose-dependent, antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models. As a therapeutic vaccine, EVM14 demonstrated the ability to induce immune memory and prevent tumor recurrence. In combination with immune checkpoint inhibitors (ICIs), EVM14 significantly enhanced anti-tumor activity, supporting exploration of combination therapies in clinical trials. EVM14, EVM16 and in-vivo CAR-T programs are the core pillars of Everest's oncology and autoimmune disease innovation strategy. SHANGHAI, March 23, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and commercialization of innovative therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for EVM14, a Tumor-Associated Antigen (TAA) vaccine. EVM14 is Everest's first internally developed mRNA therapeutic vaccine to receive FDA IND approval, marking a significant milestone in the Company's efforts to develop innovative mRNA therapeutics in oncology. EVM14 is an off-the-shelf mRNA cancer vaccine targeting multiple TAAs and is designed to treat various cancers, including non-small cell lung cancer and head and neck cancer. It utilizes mRNA encoding multiple TAAs encapsulated in a lipid nanoparticle (LNP) delivery system. Following intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs), where the mRNA is translated into target antigens. These antigens are then processed and presented by major histocompatibility complex (MHC) molecules to T cells, triggering an antigen-specific immune response. The activated T cells migrate to tumor tissues, recognize and kill the cancer cells expressing the target antigens. In preclinical studies, EVM14 induced a dose-dependent antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models. EVM14 promoted T cell infiltration into tumor tissues, increased T cell activation and cytotoxic function, decreased the Treg population and cytotoxic T lymphocyte (CTL) exhaustion - all well correlated with its anti-tumor activity. Notably, EVM14 demonstrated the ability to induce immune memory and prevent tumor recurrence, offering hope for long-term cancer-free survival. Furthermore, preclinical data demonstrated that the combination of EVM14 with ICIs greatly enhanced the anti-tumor activity, supporting clinical exploration of combination therapies. "With FDA IND approval, EVM14 has become the Everest's first internally developed mRNA therapeutic vaccine to receive clearance for global clinical development. This marks a critical breakthrough, advancing our mRNA technology from early-stage research to global clinical trials and highlighting our growing capabilities in mRNA technology. It also represents a new chapter in our 'dual-engine' strategy, evolving from a license-in model to a balanced integration of both license-in and in-house R&D innovation." said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Through our clinically validated and fully-integrated mRNA platform, we have realized synergies with our 'AI-powered' pipeline, underscoring Everest's leadership position in advancing innovation in oncology and immunology. EVM14, along with EVM16, which is a personalized cancer vaccine in clinical development and in-vivo CAR-T programs, will serve as foundational elements of our innovation strategy in oncology and autoimmune diseases. Everest is at the forefront of China's mRNA and AI-powered therapeutic development, having advanced mRNA cancer therapeutic vaccines to the clinical trials. Over the past four years, Everest has utilized its AI- and big data-powered mRNA platform to accelerate target identification, sequence design, and delivery optimization. Our proprietary algorithm for mRNA design, now in its third generation, has significantly improved target protein expression and continues to evolve through big data-driven modeling." Luo added: "This approach has enabled key breakthroughs in mRNA technology, expanded our global pipeline, and unlocked potential new opportunities for international collaboration. We look forward to advancing EVM14 into clinical trials and providing new treatment options for cancer patients. Additionally, we will submit the IND application for EVM14 to the China National Medical Products Administration (NMPA) in the near future." According to Globocan 2022 statistics, nearly 20 million new cancer cases were diagnosed worldwide, with approximately 9.7million cancer-related deaths1. Lung cancer remains the most prevalent cancer globally, responsible for almost 2.5 million new cases. Lung cancer was also the leading cause of cancer death, with an estimated 1.8 million deaths. Non-small cell lung cancer (NSCLC) accounts for 85%–90% of all lung cancers2, with squamous NSCLC (sq-NSCLC) comprising 25%–30%3. However, targetable genetic alterations, such as EGFR mutations, ALK, and ROS1 rearrangements occur in fewer than 10% of sq-NSCLC cases4, underscoring the urgent need for new treatment options. Additionally, Global Cancer Statistics 2022 reports that head and neck squamous cell carcinoma (HNSCC) is the seventh most common cancer, accounting for an estimated 890,000 new cases and 450,000 deaths annually5. more than 50% of patients with locally advanced HNSCC who have completed definitive treatment ultimately experience recurrence or metastasis6, leading to poor prognosis, high mortality rates, and diminished quality of life. Neither immunotherapy nor targeted therapy can offer long term benefits to cancer patients. EVM14's unique mechanism offers the potential to complement current treatments by enhancing the efficacy via combination therapies and delaying disease recurrence, aligning with current trends in oncology drug development. Everest has built end-to-end capabilities within its proprietary mRNA platform. The Company is advancing multiple mRNA therapies targeting cancer and autoimmune diseases, including personalized cancer vaccines (PCVs), tumor-associated antigen (TAA) cancer vaccines, immunomodulatory cancer vaccines, and in vivo CAR-T therapies. Additionally, the Company is working on next-generation LNP delivery systems to further boost cell-mediated immune responses. The Company's first internally developed personalized mRNA cancer vaccine, EVM16, has completed its first patient dosing in an investigator-initiated clinical trial (IIT) in March 2025. Our mRNA manufacturing facility in Jiashan, Zhejiang Province in China, is designed to comply with global cGMP standards and to produce at clinical- and commercial-scale. About EVM14 EVM14 Injection is a preservative-free, sterile mRNA-lipid nanoparticle (mRNA-LNP) cancer vaccine. It is formulated with mRNA solution encoding multiple tumor-associated antigens (TAAs), encapsulated in a lipid nanoparticle system. After intramuscular injection, EVM14 is taken up by antigen-presenting cells (APCs) and translated into target antigens. These antigens are processed, presented to T cells by major histocompatibility complex (MHC) molecules and activated antigen-specific T cells. The activated T cells can migrate to tumor tissues, recognize, and kill the tumor cells expressing the target antigens. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at . Forward-Looking Statements This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. Reference: 1. Globocan统计数据：. 2. Duma, N., R. Santana-Davila, and J.R. Molina, Non–Small Cell Lung Cancer: Epidemiology, Screening, Diagnosis, and Treatment. Mayo Clinic Proceedings, 2019. 94(8): p. 1623-1640 3. Socinski, M.A., et al., Current and Emergent Therapy Options for Advanced Squamous Cell Lung Cancer. Journal of Thoracic Oncology, 2018. 13(2): p. 165-183 4. Zhou, C., et al., A global phase 3 study of serplulimab plus chemotherapy as first-line treatment for advanced squamous non-small-cell lung cancer (ASTRUM-004). Cancer Cell, 2024. 42(2): p. 198-208.e3 5. Bray, F., Laversanne, M., Sung, H., et al. (2024). Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 1-35. 6. Haddad, R.I., et al., Nivolumab Plus Ipilimumab Versus EXTREME Regimen as First-Line Treatment for Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck: The Final Results of CheckMate 651. J Clin Oncol, 2023. 41(12): p. 2166-2180 SOURCE Everest Medicines 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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06 Mar 2025

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TEPMETKO Continues to Strengthens its Position as a Leading METex14 Skipping NSCLC Therapy | DelveInsight

With increasing biomarker-driven cancer treatments, TEPMETKO benefits from growing adoption in precision oncology. Competition from other MET inhibitors like TABRECTA (capmatinib) exists, but TEPMETKO's once-daily dosing and efficacy profile offer differentiation. LAS VEGAS, March 6, 2025 /PRNewswire/ -- DelveInsight's " TEPMETKO Market Size, Forecast, and Market Insight Report" highlights the details around TEPMETKO, a kinase inhibitor indicated for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TEPMETKO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. EMD Serono's TEPMETKO (tepotinib) Overview TEPMETKO is a kinase inhibitor prescribed for adult patients with metastatic non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping alterations. The active component is Tepotinib (as hydrochloride monohydrate), administered orally. Patients should be cautioned about the heightened risk of severe or fatal interstitial lung disease/pneumonitis, liver toxicity, and potential embryo-fetal toxicity, necessitating effective contraception during and shortly after treatment. Tepotinib specifically targets MET, including variants with exon 14 skipping mutations. It blocks HGF-dependent and independent MET phosphorylation, disrupting MET-driven signaling pathways. Additionally, at clinically relevant concentrations, Tepotinib inhibits melatonin 2 and imidazoline 1 receptors. In vitro studies show that it suppresses tumor cell proliferation, anchorage-independent growth, and migration of MET-dependent cancer cells. In mouse models with MET-driven tumors, including those with MET exon 14 skipping alterations, Tepotinib reduced tumor growth, sustained MET phosphorylation inhibition, and, in one case, decreased metastasis formation. The recommended dose of TEPMETKO is 450 mg taken orally once daily until disease progression or intolerable toxicity occurs. Patients should take it at the same time each day, swallowing tablets whole without chewing, crushing, or splitting them. If a dose is missed and less than eight hours remain until the next scheduled dose, patients should skip it. In cases of vomiting after taking TEPMETKO, the next dose should be taken at the usual time. Learn more about TEPMETKO projected market size for NSCLC @ TEPMETKO Market Potential Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 81% of all diagnosed cases. Early detection greatly improves outcomes, but diagnosing NSCLC and other lung cancers is challenging because their symptoms are often mistaken for common illnesses or the long-term effects of smoking. Consequently, 80% of NSCLC cases are already at advanced stages by the time they are identified, making treatment more difficult. Around 80% of EGFR mutations in NSCLC involve either exon 19 deletions or the exon 21 L858R substitution, both of which are classified as sensitizing mutations. Until the last decade, chemotherapy was the primary treatment for advanced and metastatic lung cancer. However, this changed in 2015 with the approval of the first immune checkpoint inhibitor (ICI), KEYTRUDA (pembrolizumab), as a second-line therapy for advanced cases. This was followed by TECENTRIQ (atezolizumab) in 2016. Both therapies were later approved for first-line treatment, broadening their use to a larger patient population. In 2020, the combination of OPDIVO (nivolumab) and ipilimumab also received approval as a first-line treatment for metastatic NSCLC. According to DelveInsight, the NSCLC market size across the 7MM is projected to grow from USD 30 billion in 2024, with a substantial CAGR through 2034. This growth is largely driven by the introduction of emerging therapies during the forecast period (2025–2034). Discover more about the NSCLC market in detail @ Non-small Cell Lung Cancer Market Report Emerging Competitors of TEPMETKO The NSCLC pipeline is very robust with the promising therapies such as Telisotuzumab vedotin (AbbVie), Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca), Eftilagimod alpha (Immutep), BNT311/GEN1046 (acasunlimab) (Genmab), V940 (mRNA-4157) + Pembrolizumab (Moderna Therapeutics/Merck), Plinabulin + Docetaxel (BeyondSpring), Olomorasib (LY3537982) (Eli Lilly and Company), Zipalertinib (Cullinan Oncology/Taiho Pharma), Ceralasertib (AZD6738) (AstraZeneca), TEDOPI (EP-2101; IDM 2101; OSE-2101) (OSE Immuno-therapeutics), Sigvotatug vedotin (PF08046047) (Pfizer), ANKTIVA (N-803) (ImmunityBio), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Niraparib (GSK), Savolitinib (AstraZeneca/Hutchison MediPharma), TRODELVY (Gilead Sciences), Pyrotinib (Jiangsu HengRui Medicine), Ociperlimab (BGB-A1217) (BieGene), Volrustomig (AstraZeneca), Gotistobart (BNT316/ONC-392) (OncoC4/BioNTech), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), ZYNYZ (retifanlimab/INCMGA00012) (Incyte/Macrogenics), Divarasib (GDC-6036) (Roche/Genentech), Tiragolumab (RG6058) (Roche), Sacituzumab Tirumotecan (Merck and Kelun-Biotech), JEMPERLI (dostarlimab/TSR-042) (GSK and AnaptysBio), Zongertinib (BI-1810631) (Boehringer Ingelheim), BAY 2927088 (Bayer), Serplulimab (HLX10) (Shanghai Henlius Biotech), Rilvegostomig (AZD2936) (AstraZeneca), MK-1084 (Merck, Taiho Pharmaceutical, and Astex), Domvanalimab (Arcus Biosciences and Gilead Sciences), OPDUALAG (nivolumab and relatlimab) (Bristol-Myers Squibb), Belrestotug + JEMPERLI (iTeos Therapeutics and GSK), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), Cobolimab (GSK), Livmoniplimab (AbbVie), Fianlimab (REGN3767) (Regeneron Pharmaceuticals), BNT327/PM8002 (Biotheus/BioNTech), HS-20117 (Hansoh BioMedical), IO102-IO103 + Pembrolizumab (IO Biotech), Naptumomab estafenatox (NeoTX Therapeutics/Active Biotech), FF-10832 (FUJIFILM Corporation), BNT116 (BioNTechSE/Regeneron Pharmaceuticals), CAN-2409 (Candel Therapeutics), Mecbotamab Vedotin (BA3011/CAB-AXL-ADC) (BioAtla), Bemcentinib (BGB 324/BGB-3234/R-428) (BerGenBio/Rigel Pharmaceuticals), DOVBLERON (taletrectinib/AB-106/IBI-344) (Nuvation Bio/Innovent Biologics/Daiichi Sankyo/Nippon Kayaku), Lifileucel (Iovance Biotherapeutics), IBI363 (Innovent Biologics), Sotevtamab (AB-16B5) (Alethia Biotherapeutics), Avutometinib (VS6766) (Verastem Oncology), Vebreltinib (APL-101) (Apollomics), LP-300 (Lantern Pharma), JNJ-90301900 (Johnson & Johnson Innovative Medicine), AMG 193 (Amgen), Luveltamab tazevibulin (Sutro Biopharma), PRT3789 (Prelude Therapeutics), Disitamab vedotin (Seagen), PADCEV (enfortumab vedotin) (Astellas Pharma), RP1 (Replimune), TIVDAK (tisotumab vedotin) (Seagen), Zanidatamab (Jazz Pharmaceuticals), Utidelone injectable (UTD1) (Beijing Biostar Pharmaceuticals), REGN5093-M114 (Regeneron Pharmaceuticals), SLC-391 (SignalChem Lifesciences), fulzerasib (GenFleet), Davutamig (REGN5093) (Regeneron Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sabestomig (AZD7789) (AstraZeneca), Sasanlimab (Pfizer), Selvigaltin (GB1211) (Galecto Biotech), Vepafestinib Helsinn (Healthcare/Taiho Pharmaceutical), EP0031 (A400/ KL590586) (Ellipses Pharma/Kelun-Biotech), Pamvatamig (MCLA-129) (Merus), Zidesamtinib (NVL-520) (Nuvalent), NVL-655 (Nuvalent), RMC-4630 (Revolution Medicines), REQORSA (quaratusugene ozeplasmid) (Genprex), PDC*lung01 (PDC*line Pharma), Evalstotug (BA3071) (BioAtla and BeiGene), PT-112 (Promontory Therapeutics), MRT-2359 (Monte Rosa Therapeutics), GAIA-102 (GAIA BioMedicine), Rigosertib (Traws Pharma), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), ANS03 (Avistone Biotechnology), MYTX-011 (Mythic Therapeutics), A166 (Sichuan Kelun-Biotech Bio-pharmaceutical), Atamparib (BN-2397) (Ribon Therapeutics), DELTACEL (KB-GDT-01) (Kiromic BioPharma), Carotuximab (ENV-105) (Kairos Pharma), YL202 (MediLink Therapeutics), and others. To know more about the number of competing drugs in development, visit @ TEPMETKO Market Positioning Compared to Other Drugs Key Milestones of TEPMETKO In February 2024, the FDA granted traditional approval to TEPMETKO for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. In February 2022, the EC approved TEPMETKO as monotherapy for the treatment of adult patients with advanced NSCLC harboring alterations leading to METex14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. In February 2021, Merck announced that the US FDA has approved TEPMETKO following priority review for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. This indication was approved under accelerated approval based on ORR and DOR. In October 2020, TEPMETKO received ODD for treating NSCLC with MET genomic tumor aberrations In March 2020, EMD Serono (the biopharmaceutical business of Merck KGaA), announced that the MHLW approved TEPMETKO for the treatment of patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations. In September 2019, the US FDA granted BTD for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy Discover how TEPMETKO is shaping the NSCLC treatment landscape @ TEPMETKO NSCLC TEPMETKO Market Dynamics TEPMETKO competes in a growing but highly specialized market where MET-targeted therapies are gaining traction due to their efficacy in addressing MET-altered tumors. The market for MET inhibitors is expanding as precision oncology advances and molecular diagnostics become more widely available, enabling better identification of patients who would benefit from targeted treatments like TEPMETKO. A key factor shaping TEPMETKO's market dynamics is competition. It directly competes with Novartis' TABRECTA (capmatinib), another MET inhibitor approved for the same indication. While TEPMETKO offers the advantage of once-daily dosing compared to TABRECTA's twice-daily regimen, both drugs have similar efficacy profiles, making physician and patient preference an important differentiator. Additionally, broader competition from next-generation MET inhibitors and combination therapies in clinical trials could impact TEPMETKO's long-term market position. Regulatory approvals and market access play a crucial role in TEPMETKO's adoption. The drug has been approved in multiple regions, including the U.S., Europe, and Japan, but reimbursement and pricing strategies vary by market. Payer policies, along with the cost-benefit analysis of MET inhibitors compared to other targeted therapies, influence prescription trends. Furthermore, real-world evidence and post-marketing studies will be critical in demonstrating TEPMETKO's sustained effectiveness and safety, which could support expanded indications and increased market penetration. Looking ahead, the MET inhibitor market is expected to grow with advances in biomarker-driven therapy, further refining patient selection. TEPMETKO's success will depend on continued clinical development, potential label expansions, and strategic partnerships to strengthen its competitive edge. As new entrants emerge, Merck KGaA's ability to differentiate TEPMETKO through combination strategies or enhanced formulations may determine its long-term sustainability in this evolving landscape. Dive deeper to get more insight into TEPMETKO's strengths & weaknesses relative to competitors @ TEPMETKO Market Drug Report Table of Contents Related Reports Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies including Daiichi Sankyo, AstraZeneca, Gilead Sciences, BieGene, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda Pharmaceuticals, Eli Lilly, BerGenBio, GlaxoSmithKline, Duality biologics, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. C-MET Metastatic Non-small Cell Lung Cancer Market C-MET Metastatic Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key C-MET mNSCLC companies, including Novartis, Merck, EMD Serono, AbbVie, Regeneron Pharmaceuticals, Mythic Therapeutics, Apollomics, Johnson & Johnson Innovation, Haihe Biopharma, among others. C-MET Non-small Cell Lung Cancer Pipeline C-MET Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key C-MET non-small cell lung cancer companies, including AbbVie, Janssen Research & Development, Beijing Pearl Biotechnology Limited Liability Company, Novartis, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP 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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KEGG	Wiki	ATC	Drug Bank
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Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Non-squamous non-small cell lung cancer	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	01 Dec 2024
Esophageal Squamous Cell Carcinoma	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	19 Sep 2023
Extensive stage Small Cell Lung Cancer	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	16 Jan 2023
Squamous non-small cell lung cancer	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	25 Oct 2022
Advanced gastric carcinoma	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	22 Mar 2022
Colorectal Cancer	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	22 Mar 2022
Microsatellite Instability-high Solid Tumors	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	22 Mar 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Esophageal Carcinoma	NDA/BLA	China	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	26 Aug 2022
Microsatellite Instability cancer	NDA/BLA	China	Shanghai Henlius Biotech, Inc.	23 Apr 2021
Stomach Cancer	Phase 3	China	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	30 Jan 2023
Advanced Cervical Carcinoma	Phase 3	China	Shanghai Henlius Biotech, Inc.	30 Sep 2022
Small cell lung cancer limited stage	Phase 3	United States	Shanghai Henlius Biotech, Inc.	17 May 2022
Small cell lung cancer limited stage	Phase 3	China	Shanghai Henlius Biotech, Inc.	17 May 2022
Small cell lung cancer limited stage	Phase 3	Austria	Shanghai Henlius Biotech, Inc.	17 May 2022
Small cell lung cancer limited stage	Phase 3	Czechia	Shanghai Henlius Biotech, Inc.	17 May 2022
Small cell lung cancer limited stage	Phase 3	Germany	Shanghai Henlius Biotech, Inc.	17 May 2022
Small cell lung cancer limited stage	Phase 3	Greece	Shanghai Henlius Biotech, Inc.	17 May 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ESMO_TAT2025	Not Applicable	Small Cell Lung Cancer	39	Serplulimab plus chemotherapy	enlbpziauj(xgrpcdzfnw) = btaraeidkl pdfxhegjhm (vpcrwxxitn, 3.1 - 7.2) View more	Positive	03 Mar 2025
				Second-line serplulimab plus chemotherapy	enlbpziauj(xgrpcdzfnw) = cfqlftivxj pdfxhegjhm (vpcrwxxitn, 6.9 - NR)
NCT05831891 (ASCO_GU2025) Manual	Phase 2	Renal Cell Carcinoma First line	16	Fruquintinib+serplulimab	ntbieiuuar(otfvxcpofb) = not reached fowniidetl (orhgdozexq ) View more	Positive	13 Feb 2025
NCT04547166 (ASCO_GI2025) Manual	Phase 2/3	Metastatic Colorectal Carcinoma First line Microsatellite Stable (MSS) \| PD-L1	112	Serplulimab + Bevacizumab + XELOX	slybpulnac(nyhismiauh) = kxaorrlndw yjbediopja (sdnoexkxeu ) View more	Positive	23 Jan 2025
				Placebo + Bevacizumab + XELOX	slybpulnac(nyhismiauh) = pjszjsfvdl yjbediopja (sdnoexkxeu ) View more
NCT03973112 (Pubmed \| Cancer Immunol Immunother) Manual	Phase 2	Advanced Hepatocellular Carcinoma First line	61	Serplulimab 3 mg/kg + HLX04HLX04 10 mg/kg	leviakcolr(cupfdwvypt) = ldfqanbuwj rgwhamsxeq (xaaebpbomz, 18.1 - 42.7) View more	Positive	03 Jan 2025
ESMO_IO2024 Manual	Not Applicable	Extensive stage Small Cell Lung Cancer Third line \| Second line \| First line	40	Serplulimab + Chemotherapy + Anlotinib (first-line)	qpnkkdhjoh(awtlkasjku) = sxzovwpkkd quhwxchkms (bsjthyiagi, 15.6 - NR) View more	Positive	12 Dec 2024
NCT05659251 (ESMO_IO2024) Manual	Phase 2	Esophageal Squamous Cell Carcinoma Neoadjuvant	48	Serplulimab + Chemotherapy	cpgrwrbxhn(gauirheyev) = dumbszpzzd ufkmhawoso (unjnopljfy ) View more	Positive	12 Dec 2024
NEWS Manual	Phase 2	Renal Cell Carcinoma First line	16	斯鲁利单抗+呋喹替尼	uzneboexis(xcdpvberqq) = ubmykgdswq imtsalbvns (sndvxvpzih ) View more	Positive	09 Dec 2024
ASTRUM-004R (ESMO_ASIA2024) Manual	Not Applicable	Squamous non-small cell lung cancer First line	100	Serplulimab plus Paclitaxel	cuwnpoegpr(mlysfxwjyl) = tlgpdwcwme edmfohaque (pyauwjeweb ) View more	Positive	07 Dec 2024
				Serplulimab plus Nab-paclitaxel	cuwnpoegpr(mlysfxwjyl) = besjkxtpao edmfohaque (pyauwjeweb ) View more
NCT04033354 (ASTRUM-004, NEWS) Manual	Phase 3	Squamous non-small cell lung cancer First line	359	斯鲁利单抗+化疗	nbmwgafkhl(muieaskgdf) = yhvvkupgst spvnnorxmc (xcksxstgfh ) View more	Positive	29 Sep 2024
				安慰剂+化疗	nbmwgafkhl(muieaskgdf) = stxgqfaulw spvnnorxmc (xcksxstgfh ) View more
NCT04033354 (ASTRUM-004, ESMO2024) Manual	Phase 3	Squamous non-small cell lung cancer First line	309	Serplulimab plus chemotherapy	yccczdoawj(tnfftqjfxr) = osxegsojlh xnpqznsdcf (xgeesoommi ) View more	Positive	15 Sep 2024
				Placebo plus chemotherapy	yccczdoawj(tnfftqjfxr) = gtqayvqkrh xnpqznsdcf (xgeesoommi ) View more

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