Prediction of the efficacy of neoadjuvant therapy for high-grade serous ovarian cancer using OCS score based on exosome technology: a prospective multicenter study

Start Date01 Nov 2024

Sponsor / Collaborator-

CTR20242660 / RecruitingPhase 2

一项多中心、开放标签、双队列II期临床研究：评价FH-2001胶囊联合斯鲁利单抗注射液治疗晚期实体瘤患者的安全性和初步疗效

[Translation] A multicenter, open-label, double-cohort phase II clinical study: Evaluating the safety and preliminary efficacy of FH-2001 capsules combined with slulizumab injection in the treatment of patients with advanced solid tumors

安全性导入阶段主要目的：评价FH-2001胶囊联合斯鲁利单抗注射液在晚期肝细胞癌和胃癌患者中的安全性和耐受性。次要目的: 描述FH-2001胶囊联合斯鲁利单抗单次、多次口服给药后的药代动力学特征；评价FH-2001胶囊联合斯鲁利单抗注射液在晚期肝细胞癌和胃癌患者中的初步疗效。II期剂量扩展阶段主要目的：确定 FH-2001胶囊联合斯鲁利单抗注射液在晚期肝细胞癌的RP3D; 评价 FH-2001胶囊联合斯鲁利单抗注射液在晚期肝细胞癌和胃癌患者中的初步疗效。次要目的：评价 FH-2001胶囊联合斯鲁利单抗注射液在晚期肝细胞癌和胃癌患者中的安全性。

[Translation]

The main purpose of the safety lead-in phase is to evaluate the safety and tolerability of FH-2001 capsule combined with slulizumab injection in patients with advanced hepatocellular carcinoma and gastric cancer. Secondary objectives: To describe the pharmacokinetic characteristics of FH-2001 capsule combined with slulizumab after single and multiple oral administration; to evaluate the preliminary efficacy of FH-2001 capsule combined with slulizumab injection in patients with advanced hepatocellular carcinoma and gastric cancer. The main purpose of the Phase II dose expansion phase is to determine the RP3D of FH-2001 capsule combined with slulizumab injection in advanced hepatocellular carcinoma; to evaluate the preliminary efficacy of FH-2001 capsule combined with slulizumab injection in patients with advanced hepatocellular carcinoma and gastric cancer. Secondary objectives: To evaluate the safety of FH-2001 capsule combined with slulizumab injection in patients with advanced hepatocellular carcinoma and gastric cancer.

Start Date30 Oct 2024

Sponsor / Collaborator

Jiangsu Xingsheng Xinhui Pharmaceutical Co., Ltd.

NCT06554535 / Not yet recruitingPhase 2IIT

A Single-center, Single-arm, Prospective Clinical Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Platinum-based Chemotherapy and Bayer Aspirin in Previously Untreated Patients With Extensive-stage Small Cell Lung Cancer.

Lung cancer remains a leading cause of cancer-related deaths worldwide, with small cell lung cancer (SCLC) accounting for 15-20% of all lung cancers. Extensive-stage SCLC (ES-SCLC) is associated with poor prognosis, with a median survival of 2-4 months without treatment. Although platinum-based chemotherapy is the standard first-line treatment, median survival remains under one year, highlighting the need for improved outcomes. Recent studies have demonstrated that combining PD-1 inhibitors with chemotherapy can significantly improve survival in ES-SCLC patients. Serplulimab, a novel PD-1 inhibitor, has shown promising results in extending overall survival when combined with chemotherapy in a Phase III trial. Additionally, aspirin has been found to enhance the anti-tumor effects of immunotherapy by inhibiting immune checkpoint proteins and reducing adverse events such as thrombosis and fever. This Phase II study aims to evaluate the efficacy and safety of combining serplulimab, platinum-based chemotherapy, and aspirin as a first-line treatment for patients with ES-SCLC.

Start Date01 Oct 2024

Sponsor / Collaborator

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

100 Clinical Results associated with Serplulimab

100 Translational Medicine associated with Serplulimab

100 Patents (Medical) associated with Serplulimab

405

Literatures (Medical) associated with Serplulimab

31 Dec 2024·Human vaccines & immunotherapeutics

Exploration of genetic characterization in hyperprogressive disease after immunotherapy retreatment in a patient with LCNEC: A case report

Article

Author: Chen, Jialu ; Yang, Jiayao ; Zhang, Yao ; Shou, Liumei ; Shu, Qijin ; Shao, Tianyu

Immune checkpoint inhibitors (ICIs) have emerged as a promising therapeutic option for large cell neuroendocrine carcinoma (LCNEC). However, various studies have suggested a potential risk of hyperprogressive disease (HPD) in patients receiving ICI, which might be associated with gene alterations. Here, this is the first report on an unknown primary LCNEC patient who had achieved a long-term response from ICI treatment (atezolizumab), but developed HPD after tumor progression due to receiving another ICI agent (serplulimab). The mutation region of FAT4, SMARCA4, CYLD, CTNNB1, and KIT was altered prior to serplulimab treatment compared to before atezolizumab treatment. This case suggested a potential association between these mutated genes and HPD. Patients with the aforementioned genes should caution when selecting ICI treatment. These findings required further confirmation in a larger study cohort.

31 Dec 2024·mAbs

Insights into the mechanisms of serplulimab: a distinctive anti-PD-1 monoclonal antibody, in combination with a TIGIT or LAG3 inhibitor in preclinical tumor immunotherapy studies

Article

Author: Liu, Wei ; Xiong, Aiying ; Zhang, Xuehan ; Han, Chencheng ; Liu, Rui ; Zhang, Yizhou ; Zhang, Mengli ; Song, Ge ; Li, Qianhao ; Shan, Yongqiang ; Zhu, Jun ; Wang, Qingyu ; Hu, Chen ; Yang, Wan-Jen ; Wei, Ruicheng ; Yang, Xinyi

With more than 20 anti-PD-1/PD-L1 antibodies currently marketed, anti-PD-1 therapy has become a cornerstone of tumor immunotherapy. These agents, however, exhibit notable disparities in their characteristics and clinical performance. For instance, in the field of small cell lung cancer (SCLC) where the majority of anti-PD-1 antibodies have yielded limited success, serplulimab produced impressive survival improvements and was approved for this indication by China's National Medical Products Administration. Serplulimab's marketing authorization application also received a positive opinion from the European Medicines Agency. Nevertheless, the molecular mechanism underpinning serplulimab's superiority over its competitors remains elusive. We characterized the differences between serplulimab with approved PD-1/PD-L1 inhibitors (pembrolizumab and nivolumab) in terms of their binding features and functions in vitro and anti-tumor activity in vivo. Cellular pathways underlying the efficacy of serplulimab were also investigated. In comparison to competitors, serplulimab robustly induces PD-1 receptor endocytosis while fostering weaker PD-1-CD28 cis interactions. This phenomenon could mitigate the dephosphorylation of CD28 by SHP2, thereby facilitating sustained and robust T cell activation. While serplulimab and pembrolizumab exhibited similar performance in vitro and in vivo studies, serplulimab consistently demonstrated superior tumor killing efficacy compared to pembrolizumab upon co-administration with anti-TIGIT or anti-LAG3 inhibitors. Mechanistically, the serplulimab combination effectively reduces tumor microenvironment Treg cell populations, augments effector and memory T cell populations, and more potently modulates genes associated with diverse facets of the immune system, surpassing the effects of the pembrolizumab combination. In summary, our data underscore serplulimab as a differentiated PD-1 monoclonal antibody with best-in-class therapeutic potential.

20 Oct 2024·Expert review of pharmacoeconomics & outcomes research

Cost-effectiveness of adding serplulimab to first-line chemotherapy for extensive-stage small-cell lung cancer in China

Article

Author: Liu, Huanlong ; Kang, Shuo

OBJECTIVE:

The aim of the current study was to evaluate the cost-effectiveness of serplulimab plus chemotherapy compared chemotherapy alone as first-line strategy for patients with ES-SCLC in China.

METHODS:

A decision-analytic model that based on the Chinese health-care system perspective was conducted to evaluate the economic benefits for the two competing first-line treatment. The clinical survival and safety data were obtained from the ASTRUM-005 trial, cost and utility values were gathered from the local charges and previously published study. Both cost and utility values were discounted at an annual rate of 5%. Sensitivity analyses and subgroup analyses were performed to examine the robustness of the model results.

RESULTS:

Serplulimab plus chemotherapy could bring additional 0.25 QALYs with the marginal cost of $37,569.32, resulting in an ICER of $147,908.74 per additional QALY gained. Sensitivity analyses confirmed that model results were robust. Subgroup analyses revealed that adding serplulimab to first-line chemotherapy were unlikely to be the cost-effective option for all subgroup patients.

CONCLUSIONS:

Serplulimab plus chemotherapy was unlikely to be the cost-effective first-line strategy compared with chemotherapy alone for patients with ES-SCLC in China. Reduced the price of serplulimab could increase its cost-effective.

144

News (Medical) associated with Serplulimab

08 Nov 2024

·www.prnewswire.com

Henlius and SVAX Forge Strategic Partnership in the MENAT Market

SHANGHAI, Nov. 8, 2024 /PRNewswire/ -- On the morning of November 7, at the 7th China International Import Expo (CIIE), Henlius (2696.HK) entered into a strategic collaboration with AL-TIRYAQ AL-KHALAWI Medical Company ("SVAX"), a subsidiary entity of Saudi Arabia's prominent family business group in the healthcare sector, the Fakeeh Family. The two parties will establish joint ventures in Saudi Arabia to integrate Henlius' leading capabilities in the research, development, and manufacturing of biologics with SVAX's local expertise in registration, market access, and commercialization. The collaboration seeks to advance the global registration and commercialization of multiple Henlius products and enhance the accessibility of advanced biologics across the Middle East, North Africa, and Türkiye (MENAT) countries, and benefit more patients. The signing ceremony was attended by Ms. Weilai Shen, Director of the Foreign Economic Cooperation Department of the Shanghai Municipal Commission of Commerce, Mr. Gang Ling, The Science and Economy Commission of the People's Government of Shanghai Pudong New Area, Mr. Qiyu Chen, Co-CEO of Fosun International, Mr. Yifang Wu, Chairman of Fosun Pharma, Mr. Wenjie Zhang, Executive President of Fosun Pharma and Chairman of Henlius, Mr. Ammar Fakeeh, Chairman of the Family Business, and Prof. Mazen M. Hassanain, Founder and Managing Director of SVAX. According to the agreement, Henlius and SVAX will establish joint ventures for commercialization and manufacturing in Saudi Arabia and will collaborate on a series of Henlius products in the MENAT region, including HANDAYUAN (adalimumab, HLX03) and HANBEITAI (bevacizumab, HLX04), to conduct local commercial and manufacturing activities. In addition, the two parties will initially focus on jointly investing in the development of Henlius' investigational biosimilar of pembrolizumab, HLX17, to accelerate its global registration and commercialization. Mr. Wenjie Zhang, Executive President of Fosun Pharma and Chairman of Henlius, stated, "Our collaboration with SVAX is a crucial step in Henlius' global blueprint, strengthening our presence in key markets while enhancing our international competitiveness. Through this partnership, we aim to drive innovation and growth for both parties, advance the research and manufacturing of high-quality biologics, and deliver more affordable therapies to patients in MENAT countries, thereby contributing to the global healthcare initiative. " Dr. Jason Zhu, CEO of Henlius, said, "We are delighted to collaborate with SVAX. This partnership not only complements our global strategy but also reaffirms our commitment to 'patient-centered' care. SVAX's dedication to innovation and improving regional healthcare closely aligns with Henlius' mission. Together, by combining SVAX's extensive resources and local expertise in MENAT with Henlius' global outlook and innovative capabilities, we are poised to bring more high-quality, innovative biologics to patients across the region and beyond." Mr. Ammar Fakeeh, Chairman of the Family Business, stated, "We are honored to forge this strategic partnership with Henlius, whose excellence in biopharmaceutical innovation perfectly complements our mission to elevate healthcare in the MENAT region. By joining forces, we are enhancing access to essential, high-quality biologics and strengthening the foundations of a resilient healthcare ecosystem in Saudi Arabia and beyond. This collaboration represents an important step forward in delivering advanced therapies to patients, embodying our commitment to health, innovation, and sustainable impact." Prof. Mazen Hassanain, Founder and Managing Director of SVAX, stated, "We at SVAX are delighted to enter this strategic partnership with Henlius, a company known for its commitment to high-quality and innovative biologic medicines. Combining our knowledge and experience in regulatory, marketing, sales, and local manufacturing with Henlius' expertise in biopharmaceutical development and global supply, we aim to bring cutting-edge therapies to the MENAT region and impact patients' lives. This partnership aligns with our dedication to advancing healthcare in the Kingdom of Saudi Arabia and beyond, fostering an ecosystem where life-changing therapies are accessible to those who need them. Together with Henlius, we look forward to driving growth, innovation, and healthcare accessibility across the region." As a global, innovative biopharmaceutical company, Henlius is dedicated to offering high-quality, affordable, and innovative biologic medicines for patients worldwide, focusing on oncology, autoimmune diseases, and ophthalmic diseases. Henlius continuously enhances the development and operational efficiency of its integrated R&D, production, and commercialization platform. Through various measures to improve product accessibility, the company drives the commercial growth of core products and achieves sustained high-quality profitability. Henlius has proactively built a diversified, high-quality product pipeline covering over 50 molecules. Six products have been launched in China, three have been approved for marketing in overseas markets, and 24 indications are approved worldwide, benefiting over 670,000 patients. Specifically, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S. and Zercepac® in Europe) has been approved in 49 countries and regions globally, making it the China-developed mAb biosimilar with the most marketing approvals and benefiting over 215,000 patients with breast and gastric cancer. Henlius collaborates with international partners to promote China's biopharmaceutical innovation and advance global development, with a presence across Asia, Europe, Latin America, North America, and Oceania. The MENAT region represents a significant part of the global pharmaceutical market. With growing healthcare needs and supportive government policies, the biopharmaceutical industry in the area is witnessing a rapid transformation. In June 2024, Zercepac® successfully shipped to Saudi Arabia, becoming the first China-developed monoclonal antibody (mAb) to enter the Middle Eastern market. The strong tie between Henlius and SVAX will help achieve joint development for the two parties and foster pharmaceutical innovation in emerging markets. Henlius remains committed to enhancing its global competitiveness, meeting global clinical needs, and spurring biopharmaceutical innovation. About SVAX SVAX is a pioneering Saudi company with a mission to localizing biomanufacturing within Saudi Arabia and ensuring a steady, high-quality supply of vaccines and biologics for the region. Established to bolster national health security, SVAX actively supports the region's preparedness for pandemics against infectious diseases. Aligned with Saudi Vision 2030 and the Saudi National Biotechnology Strategy, the company is at the forefront of nationalizing the biomanufacturing sector by employing highly skilled Saudi scientists and professionals. SVAX is distinguished as a local developer and manufacturer of essential biologics that serves Saudi Arabia and the broader MENAT region. The company operates through three strategic business segments: innovation, manufacturing, and advisory services. Its innovation efforts are focused on advanced R&D in biologics and vaccines, driving forward innovation and collaboration to bring cutting-edge therapies to market. In manufacturing, SVAX is establishing a state-of-the-art technologies and facilities to produce vaccines and biologics that meet global standards. Meanwhile, through its advisory services, SVAX offers expert consulting to support and accelerate the development of a strong biotech industry across the region. Through these initiatives, SVAX is uniquely positioned to drive transformative change in biomanufacturing, ensuring that the region remains resilient, innovative, and prepared for future healthcare challenges. 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, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, 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 over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products 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) and HANNAIJIA (neratinib), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. What's more, Henlius has conducted over 30 clinical studies for 16 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 Approval

30 Oct 2024

·www.prnewswire.com

Fosun Pharma Announces 2024Q3 Financial Results

Revenue Exceed RMB30.9 Billion with R&D Expenditure RMB3.9 Billion Continuing to Consolidate its Dominant Position In The fields of Breast Cancer and Lung Cancer SHANGHAI, Oct. 29, 2024 /PRNewswire/ -- On October 29, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma" or "the Group"; Stock Code: 600196.SH; 02196.HK), announced its operating performance for the first three quarters of 2024. From January to September 2024, Fosun Pharma achieved revenue of RMB30.91 billion, an increase of about 5.74% YoY after excluding COVID-related products. The net profit attributable to owners of the parent of the Group after deducting extraordinary gain or loss amounted to RMB1.84 billion, up by 24.58% YoY. In 2024, Fosun Pharma will further focus on innovative drugs and high-value devices, and continue to promote lean operations, cost reduction, efficiency improvement, and asset rationalization to optimize assets and financial structure, actively promote supply chain management and operational efficiency, and achieve healthy operating cash flow. In the first three quarters of 2024, the net cash flow from operating activities of Fosun Pharma was RMB2.99 billion, a year-on-year increase of 21.33%; the management expense ratio decreased by 0.15 percentage points YoY; excluding the impact of newly acquired companies, management expenses decreased by approximately RMB300 million on the same basis. Focusing on advantageous therapeutic areas with innovative R&D pipelines continue to advance In terms of innovative R&D, Fosun Pharma continues to focus on advantageous pipelines to achieve efficient results and continuous implementation of innovative products. In the first three quarters of 2024, Fosun Pharma's R&D expenditure totaled RMB3.92 billion. In particular, R&D expenses were RMB2.65 billion. In addition to independent R&D, the Group fully implemented an open R&D model, and incubated and invested in R&D projects by initiating/managing industrial funds and other diversified ways, so as to ensure the sustainability of innovation and R&D. Fosun Pharma's innovative drug business mainly covers the core therapeutic areas of solid tumors, hematological tumors and immuno-inflammatory diseases, with emphasis on the enhancement of the core technology platforms of antibody/ADCs, cellular therapy and small molecules, to create an open and global innovative R&D system, continuously enhance pipeline value, and promote the development and commercialization of its products. In the field of tumor immunotherapy, on September 13, 2024, Fosun Pharma announced it will acquire the 50% stake in Fosun Kite and will wholly own Fosun Kite (now renamed as "Fosun Kairos"). In the future, Fosun Kairos will serve as the core platform of Fosun Pharma's cell therapy, continue to focus on the field of tumor immunotherapy, as well as to promote the development and commercialization of existing licensed products, Axi-Cel (i.e. Fosun Kite's marketed product "Yi Kai Da") and Brexu-Cel (i.e. Fosun Kite's pipeline project FKC889), in Chinese mainland, Hong Kong SAR and Macau SAR with Kite Pharma. In the third quarter of 2024, Fosun Pharma's multiple independently developed innovative products and pipeline clinical trial results were announced in industry conferences and journals, further consolidating its dominant position in the fields of hematological tumors, breast cancer, lung cancer and other tumors. Particularly, the interim analysis results of the Phase III study of Foritinib Succinate (SAF-189s), an innovative drug independently developed to treat ALK-positiveb advanced non-small cell lung cancer (NSCLC), were released during the 2024 World Conference on Lung Cancer ("WCLC"). The above-mentioned studies have found that the overall efficacy of Foritinib Succinate is good. Compared with crizotinib treatment, it can significantly improve PFS and reduce the risk of CNS progression. Its safety is controllable, and no new safety signals appeared after treatment. Faritinib Succinate is expected to break through the current clinical difficulties faced in the treatment of ALK-positive NSCLC and bring new treatment options to NSCLC patients. The multicenter real-world study of Fosun Pharma's self-developed serplulimab-based immunochemotherapy for extensive-stage small cell lung cancer was released at the 2024 WCLC. The ASTRUM-005R study provides additional empirical evidence to support the therapeutic value of serplulimab plus chemotherapy and complements the pivotal data from the ASTRUM-005 clinical trial. Additionally, during the reporting period, the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency (EMA) issued a positive opinion recommending approval for Fosun Pharma's self-developed serplulimab injection in combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). The CHMP's opinion will be submitted to the European Commission (EC) as a reference for marketing authorization approval. Results of the phase 2 study of HLX22, an innovative anti-HER2 monoclonal antibody (mAb), in combination with Han Qu You (trastuzumab) and chemotherapy for the first-line treatment of HER2-positive advanced gastric/gastroesophageal junction (G/GEJ) cancer were presented on 2024 ESMO Gastrointestinal Cancers Congress (ESMO GI) and MED, a flagship clinical and translational research monthly journal by Cell Press. The results showed that add HLX22 to HLX02 (trastuzumab) and chemotherapy as first-line therapy improved efficacy in HER2-positive G/GEJ cancer patients with manageable safety. In September 2024, Fosun Pharma announced the Biologics License Application ("BLA") for the licensed product RT002 (DaxibotulinumtoxinA-lanm, Chinese trademark: 达希斐®) for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients, was approved by the National Medical Products Administration ("NMPA"), becoming the first DaxibotulinumtoxinA-lanm approved for marketing in Chinese mainland. Additionally, the results of a Phase III multicenter, double-blind, placebo-controlled study conducted in China for the treatment of moderate to severe glabellar lines were published in the Journal of Plastic, Reconstructive & Aesthetic Surgery (JPRAS). The study demonstrates that the product provides durable efficacy and high safety in Chinese patients with moderate to severe glabellar lines. Actively implementing share repurchases and increasing holdings with continuous efforts on enhancing ESG Fosun Pharma, a company listed on both the A-share and H-share markets, and its controlling shareholder Fosun High Tech have actively engaged in share repurchases and increased holdings this year, demonstrating confidence in the Company's future development and further boosting market confidence. In the first three quarters of 2024, Fosun Pharma spent approximately RMB127 million and approximately HKD66.9 million to repurchase around 5.68 million A shares and 5.47 million H shares respectively. As of now, the H Share Repurchase Plan is still valid. In addition, the controlling shareholder Fosun High Tech, has spent a total of approximately RMB101 million to increase its holdings of around 4.30 million A shares of Fosun Pharma, under the latest Shareholding Increase Plan. Founded in 1994 and with three decades of development, Fosun Pharma has grown into a global innovation-driven pharmaceutical and healthcare industry group. The Company always regards innovation as its primary social responsibility, consistently focusing on unmet clinical needs, prioritizing innovative R&D, advancing the launch of innovative products, promoting drug accessibility and affordability, and driving high-quality corporate growth. Fosun Pharma maintained an A grade rating in MSCI ESG Ratings for three consecutive years and an A- rating in HSI ESG, ranking among the top tier in the healthcare industry for pharmaceuticals and biotechnology. It was also selected as a constituent of the Hang Seng (China A) Corporate Sustainability Benchmark Index ("HSCASUSB"), Hang Seng (China A) Corporate Sustainability Index ("HSCASUS"), and Hang Seng (Mainland and HK) Corporate Sustainability Index ("HSMHSUS"). With its sustained excellence in innovation and global operational capabilities, Fosun Pharma has been recognized by multiple authoritative institutions in innovative R&D, ESG and other areas. The Company ranked in the top four of China's 2023 Top 100 Pharmaceutical Industry, was included in the "China Best Managed Companies" List (BMC) for the second consecutive year and was listed in Forbes 2024 China ESG 50. In addition, the Company has actively introduced its independently developed artemisinin-based innovative products to Africa, providing a Chinese solution to the global fight against malaria. This initiative highlights the inclusive, diverse, and open nature of ESG and earned Fosun Pharma recognition as an "Inspirational ESG Case", serving as a model for corporate ESG practices. *** About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196.SH, 02196.HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and unmet clinical needs-oriented. Through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and industrial investment, the company continues to enrich its innovative product pipeline and focus on differentiated product R&D with high-tech barriers, to continuously enhance the value of its pipeline. Fosun Pharma's innovative products focus on core therapeutic areas such as solid tumors, hematologic tumors and immunity inflammation. It also strengthens core technology platforms such as antibodies/ADC, cell therapy, and small molecules. Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma adheres to the business philosophy of "Innovation for Good Health", continues to promote innovative transformation, actively deploys internationalization, strengthens business focus by product lines, promotes integrated operations and efficiency improvement, and is dedicated to being the global leading integrator of pharmaceutical and healthcare innovation. For more information, please visit the official website: SOURCE Fosun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyDrug ApprovalPhase 2Phase 3

01 Oct 2024

·pipelinereview.com

Primary Endpoint Met in Phase 3 Comparative Clinical Study of Perjeta® (pertuzumab) Biosimilar Candidate HLX11

SHANGHAI, China & JERSEY CITY, NJ, USA I September 30, 2024 I Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) announced that the phase 3 comparative clinical trial for the investigational Perjeta ® (pertuzumab) biosimilar HLX11 met the primary endpoint. In 2022, Henlius entered into a license and supply agreement with Organon for the exclusive commercialization rights to two biosimilar candidates, including HLX11. The agreement licenses the global commercialization rights for the product, except for China, to Organon. The multicenter, randomized, double-blind, parallel-controlled phase 3 clinical study ( NCT05346224 ) aimed to compare the efficacy and safety of HLX11 with reference Perjeta ® (pertuzumab) as a neoadjuvant therapy in patients with HER2-positive, HR-negative early, or locally advanced breast cancer as part of a complete treatment regimen. Eligible patients were randomized 1:1 to receive either HLX11 or reference Perjeta ® (pertuzumab) in combination with trastuzumab and docetaxel every three weeks for four cycles. The primary endpoint of this study was the total pathological complete response (tpCR) rate assessed by Independent Review Committee (IRC). The secondary endpoints currently being analyzed included tpCR rate assessed by investigators, breast pathologic complete response (bpCR) rate, objective response rate (ORR), event-free survival (EFS), disease-free survival (DFS), safety, pharmacokinetics, and immunogenicity. The primary endpoint of this study was met. Pertuzumab has been approved in various countries and regions in combination with trastuzumab and chemotherapy for the neoadjuvant, first-line, and adjuvant treatment for certain advanced HER2-positive breast cancer. 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. To date, 6 products have been launched in China, 3 have been approved for marketing in overseas markets, 24 indications are approved worldwide, and 3 marketing applications have been accepted for review in China 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 proactively built a diversified and high-quality product pipeline covering over 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products 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) and HANNAIJIA (neratinib), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. What’s more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. About Organon Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon offers more than 60 medicines and products in women’s health in addition to a growing biosimilars business and a large franchise of established medicines across a range of therapeutic areas. Organon’s existing products produce strong cash flows that support investments in innovation and future growth opportunities in women’s health and biosimilars. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets. Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. For more information, visit http://www.organon.com and connect with us on LinkedIn , Instagram , X (formerly known as Twitter) and Facebook . SOURCE: Organon

Phase 3License out/inImmunotherapyClinical ResultDrug Approval

100 Deals associated with Serplulimab

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R&D Status

Approved

10 top approved records.

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

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Non-squamous non-small cell lung cancer	NDA/BLA	CN	Shanghai Henlius Biopharmaceuticals Co. , Ltd.	12 Dec 2023
Microsatellite Instability cancer	NDA/BLA	CN	Shanghai Henlius Biotech, Inc.	23 Apr 2021
Stomach Cancer	Phase 3	CN	Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.	30 Jan 2023
Advanced Cervical Carcinoma	Phase 3	CN	Shanghai Henlius Biotech, Inc.	30 Sep 2022
Small Cell Lung Cancer	Phase 3	CN	Shanghai Henlius Biotech, Inc.	11 May 2022
Small Cell Lung Cancer	Phase 3	AU	Shanghai Henlius Biotech, Inc.	11 May 2022
Small Cell Lung Cancer	Phase 3	AT	Shanghai Henlius Biotech, Inc.	11 May 2022
Small Cell Lung Cancer	Phase 3	CZ	Shanghai Henlius Biotech, Inc.	11 May 2022
Small Cell Lung Cancer	Phase 3	GR	Shanghai Henlius Biotech, Inc.	11 May 2022
Small Cell Lung Cancer	Phase 3	HK	Shanghai Henlius Biotech, Inc.	11 May 2022

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04033354 (ASTRUM-004, NEWS) Manual	Phase 3	Squamous non-small cell lung cancer First line	359	斯鲁利单抗+化疗	lunsroavrh(dmwvoryzjt) = dokvbupbjm fhgknqhsam (qqyjxvfpgv ) View more	Positive	29 Sep 2024
				安慰剂+化疗	lunsroavrh(dmwvoryzjt) = ecrrhydmma fhgknqhsam (qqyjxvfpgv ) View more
NCT04033354 (ASTRUM-004, ESMO2024) Manual	Phase 3	Squamous non-small cell lung cancer First line	309	Serplulimab+chemotherapy	zpgyctlala(gytvneagmj) = jbzoifxvyz rstoriukoa (wuxvftjvho ) View more	Positive	15 Sep 2024
				Placebo+chemotherapy	zpgyctlala(gytvneagmj) = qjyfgmrbdf rstoriukoa (wuxvftjvho ) View more
NCT05443646 (ASTRUM-LC01, ESMO2024) Manual	Phase 2	Small Cell Lung Cancer Consolidation	55	Serplulimab 300mg	cwjegxieno(lezwxoimqy) = bqycjzgoks tfjnuymakc (mguklvizlk, 60.1 - 85.8) View more	Positive	14 Sep 2024
ESMO2024	Not Applicable	Extensive stage Small Cell Lung Cancer	-	Serplulimab	lnfkfmuzru(gpxrstlorv) = fjsvrkvnsv gwphdesujd (mynpckgnzw ) View more	-	14 Sep 2024
				Chemotherapy	lnfkfmuzru(gpxrstlorv) = oqlhixpvkr gwphdesujd (mynpckgnzw ) View more
NCT04063163 (ASTRUM-005, WCLC2024) Manual	Phase 3	Extensive stage Small Cell Lung Cancer First line	538	Serplulimab combined with chemotherapy	rivbgexcim(sdjcjtbdvs) = iiphbntwzx ejwfujholz (lusqesjxep ) View more	Positive	08 Sep 2024
				Serplulimab combined with chemotherapy (the Asian)	rivbgexcim(sdjcjtbdvs) = qnivkvypmf ejwfujholz (lusqesjxep ) View more
NCT04547166 (Literature) Manual	Phase 2/3	Metastatic Colorectal Carcinoma First line	114	Serplulimab plus HLX04 and XELOX	pbjouthjtl(gwwnmgopyo) = gnqzsviims zbxrhhqkth (jzmlbuskzs ) View more	Positive	24 Jul 2024
				Placebo plus bevacizumab and XELOX	pbjouthjtl(gwwnmgopyo) = qhraowwine zbxrhhqkth (jzmlbuskzs ) View more
NCT04547166 (Phase 2/3 trial, Pubmed)	Phase 2	Metastatic Colorectal Carcinoma First line pMMR \| MSS	114	Serplulimab + HLX04 + XELOX	utgfcqvatr(krcqzheajr) = ztsftgumcn hordzwmmrm (dqjlcqvxwf )	Positive	09 Jun 2024
				Placebo + Bevacizumab + XELOX	utgfcqvatr(krcqzheajr) = bsywrxkset hordzwmmrm (dqjlcqvxwf )
NCT04547166 (ASCO2024) Manual	Phase 2/3	Metastatic Colorectal Carcinoma First line	114	Serplulimab plus HLX04 and XELOX	ibyhngztce(ekxqapxzli) = kjmsydxnhf kllemosnze (dakvrfkeeb, 10.7 - 24.2) View more	Positive	24 May 2024
				Placebo plus bevacizumab and XELOX	ibyhngztce(ekxqapxzli) = jeeahdpsfe kllemosnze (dakvrfkeeb ) View more
NCT04063163 (ASTRUM-005, ASCO2024) Manual	Phase 3	Extensive stage Small Cell Lung Cancer First line	585	Serplulimab 4.5 mg/kg + chemotherapy	hjczotbene(wrgmthuidd) = odvkfricje zvgmrvmcbe (hxunottwpn ) View more	Positive	24 May 2024
				Placebo + chemotherapy	hjczotbene(wrgmthuidd) = ztimnxgnfz zvgmrvmcbe (hxunottwpn ) View more
ASCO2024 Manual	Not Applicable	Esophageal Carcinoma First line	57	serplulimab combined with chemotherapy	eiygekulsd(djrpmclzmi) = trnypgcbui zdysqhpavd (zgavlbxmjo ) View more	Positive	24 May 2024
				serplulimab combined with chemotherapy (ESCC)	bxldxrxgoq(iigfsldeqv) = moecwjbdjo kpbpgifnum (jzfsuqjawr ) View more

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