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Eli Lilly China Appoints Yan Qiong as Vice President of Diabetes Business Unit
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Effective October 10, 2024, Yan Qiong will join the management team of Eli Lilly (NYSE: LLY) China as the vice president of the diabetes products business unit. She will report directly to Huzur Devletsah, the president and general manager of Lilly China. Yan Qiong brings nearly two decades of experience…
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InnoCare Pharma Achieves Positive Phase II Results for TYK2 Inhibitor ICP-488 in Psoriasis Treatment
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China-based InnoCare Pharma (HKG: 9969; SHA: 688428) has announced positive results from a Phase II clinical study for its TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor, ICP-488, in patients with moderate to severe plaque psoriasis. ICP-488 is a potent and selective TYK2 allosteric inhibitor that is being developed to treat…
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Ascletis Pharma’s ASC40 Earns FDA Breakthrough Therapy Designation for Fibrotic MASH
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced that ASC40 (denifanstat), a fatty acid synthase (FASN) inhibitor co-developed with US partner Sagimet Biosciences Inc. (NASDAQ: SGMT), has received a breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA). The designation is for the treatment of patients with…
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HitGen Inc. Partners with Ablink Biotech to Develop Antibody-Oligonucleotide Conjugates
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China-based HitGen Inc. (SHA: 688222) has entered into a partnership with compatriot firm Ablink Biotech to integrate their world-leading trillion-level DNA-Encoded Libraries (DELs), a comprehensive small nucleic acid drug discovery and production platform, and a 300 billion-level biopharmaceutical molecule library. The collaboration aims to provide research and development services for…
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Sichuan Biokin’s BL-B01D1 Earns Breakthrough Therapy Designation for Esophageal Cancer from China’s CDE
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) has announced that its bispecific antibody drug conjugate (ADC), BL-B01D1, has received breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) in China. The designation is for the treatment of patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC) who…
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Merck’s Keytruda Meets Primary Endpoint in Phase III Study for Head and Neck Cancer
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US pharmaceutical giant Merck & Co., Inc. (MRK, NYSE: MRK) has announced that the Phase III KEYNOTE-689 study for its PD-1 inhibitor Keytruda (pembrolizumab) has met its primary endpoint of event-free survival (EFS) in patients newly diagnosed with stage III or IVA, resected, locally advanced head and neck squamous cell…
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Boehringer Ingelheim’s Survodutide Earns FDA Breakthrough Therapy Designation for MASH Treatment
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German pharmaceutical company Boehringer Ingelheim has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for its drug candidate survodutide (BI 456906), a dual glucagon/GLP-1 receptor agonist, for the treatment of non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) in adults with moderate or advanced fibrosis (stages 2 or…
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Eli Lilly Appoints Thomas J. Fuchs as First Chief AI Officer to Lead AI Initiatives
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Eli Lilly and Company (NYSE: LLY) has announced the appointment of Thomas J. Fuchs, Dr.sc., as its first chief AI officer, effective from October 21, 2024. Fuchs will be responsible for providing strategic direction and leadership for AI initiatives across the company, including drug discovery, clinical trials, manufacturing, and commercial…
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Zephyrm Bioscience Limited Files for IPO on Hong Kong Stock Exchange
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China-based Zephyrm Bioscience Limited, a biopharmaceutical company specializing in the development of novel pluripotent stem cell (PSC) derived cell therapies, has filed for an initial public offering (IPO) on the Hong Kong Stock Exchange. Details of the offering have not been disclosed at this stage. Established in 2017, Zephyrm Bio…
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Pfizer Halts Development of Sisunatovir, an RSV Antiviral, After Phase II/III Trials
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U.S. pharmaceutical giant Pfizer (NYSE: PFE) has decided to discontinue the development of sisunatovir, an antiviral drug for respiratory syncytial virus (RSV), following challenges including drug-drug interactions with antacids. The drug had reached the Phase II/III trial stage, and the decision will see two trials discontinued, according to Endpoints News.…
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Biogen’s China Unit Gets Conditional NMPA Nod for Qalsody (Tofersen) in ALS Treatment
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Biogen (NASDAQ: BIIB)’s Chinese subsidiary has announced that it has received conditional approval from the National Medical Products Administration (NMPA) for its drug Qalsody (tofersen) for the treatment of adult patients with amyotrophic lateral sclerosis (ALS) who have a superoxide dismutase 1 (SOD1) gene mutation. ALS is a rare disease,…
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Joincare Pharmaceutical Secures NMPA Approval for Triptorelin Microspheres to Treat Endometriosis
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China-based Joincare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) has announced that it has received another market approval from the National Medical Products Administration (NMPA) for its triptorelin microspheres, now indicated for the treatment of endometriosis. Triptorelin microspheres are an in-house developed long-acting formulation administered via monthly intramuscular injection as…
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CSPC Pharmaceutical Secures NMPA Approval for Omalizumab Biosimilar
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novartis’s Xolair (omalizumab), an anti-human immunoglobulin E (IgE) monoclonal antibody (mAb). CSPC Pharma’s biosimilar product is described as the first omalizumab biosimilar developed…
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Ningbo Menovo Pharmaceutical Partners with Nanjing Huawe Medicine for High-End Product Development
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Ningbo Menovo Pharmaceutical Co., Ltd (SHA: 603538) has entered into a strategic partnership with Nanjing Huawe Medicine Technology Group Co., Ltd, a move aimed at leveraging synergies in research and development (R&D) and manufacturing resources. The collaboration seeks to reduce drug development costs and enhance product competitiveness in the high-end…
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CSPC Pharmaceutical’s ADC CPO301 Earns Second Fast-Track Designation in the US for NSCLC Treatment
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its best-in-class antibody drug conjugate (ADC) CPO301 has received another fast-track status in the United States for the treatment of non-small cell lung cancer (NSCLC). The EGFR targeted ADC has been granted this status for the treatment of epidermal growth…
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Bio-Thera Solutions Ltd Strikes Licensing Deal with Gedeon Richter for BAT1706 Biosimilar
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Guangzhou-based Bio-Thera Solutions Ltd has announced a licensing agreement with Hungary’s Gedeon Richter Plc for BAT1706, its biosimilar version of Roche’s (SWX: RO) Avastin (bevacizumab). Under the agreement, Gedeon Richter will obtain exclusive commercialization rights for the drug in the European Union (EU), the UK, Switzerland, Australia, and other European…
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Jiangsu Aidea Pharmaceutical Secures NMPA Approval for Expanded Indication of Fubangde in HIV Treatment
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China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that the National Medical Products Administration (NMPA) has approved an additional indication filing for its HIV treatment Fubangde (ainuovirine, lamivudine, tenofovir disoproxil). The new indication targets two groups of adults infected with human immunodeficiency virus type 1 (HIV-1) weighing over…
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Ascentage Pharma Receives Approval for Two Phase III Trials of APG-2449 in NSCLC
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China-based biopharmaceutical company Ascentage Pharma (HKG: 6855) has announced that it has received approval from the Center for Drug Evaluation of the National Medical Products Administration (NMPA) to conduct two separate Phase III clinical studies assessing its investigational drug APG-2449. The trials will evaluate the FAK/ALK/ROS1 tyrosine kinase inhibitor (TKI)…
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MicroPort Endovascular MedTech’s Fiber Wool Plug Spring Coil Gains NMPA Marketing Approval
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016) has received marketing approval from the National Medical Products Administration (NMPA) for its fiber wool plug spring coil, a device used for the filling treatment of peripheral vascular aneurysms, arteriovenous malformations, and arteriovenous fistulas. The spring coil is constructed from a platinum…
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Kailera Therapeutics Emerges with USD 400 Million in Series A Funding for Anti-Obesity Pipeline
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Kailera Therapeutics, a newly launched US-based biotechnology company, secured USD 400 million in Series A financing last week. Previously operating as Hercules CM Newco Inc., the company was established by a consortium of investors including Bain Capital Life Sciences, RTW Investments, Atlas Venture, and Lyra Capital. The pipeline of Kailera…
