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Kira Pharmaceuticals Gains NMPA Approval for Phase II Study of KP104 in PNH
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Sino-US biotech Kira Pharmaceuticals has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase II clinical study assessing the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104, a first-in-class bifunctional biologic. The drug will be evaluated as a treatment for paroxysmal nocturnal hemoglobinuria…
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RemeGen’s Telitacicept Gains EU, China Approvals for Global Phase III Study
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China-based pharma firm RemeGen (HKG: 9995) has announced receiving approvals from authorities in the European Union (EU) and China to conduct a global multi-center Phase III clinical study for its fusion protein drug telitacicept in systemic lupus erythematosus (SLE). This marks a significant step forward in the development of innovative…
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Zelgen’s Jacktinib Shows Strong Efficacy in Phase III Myelofibrosis Study
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has published major data from a Phase III clinical study for its Janus kinase (JAK) inhibitor, jacktinib, in patients with medium- to high-risk myelofibrosis (MF). The results indicate an excellent efficacy and safety profile for the drug. A New Drug Application (NDA) for…
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Ningbo Menovo to Sell Zhejiang Liaoyuan Pharma Stake to Jemincare for RMB 512.58M
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China-based Ningbo Menovo Pharmaceutical Co., Ltd (SHA: 603538) has announced plans to transfer all of its ownership in Zhejiang Liaoyuan Pharmaceutical Co., Ltd (23,771,218 shares, or 84.5661% of the target company’s total shares) to Jiangxi Jemincare Group for a consideration of RMB 512.58 million (USD 71.2 million). The deal is…
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Alioth Biotech Raises RMB 100M in Series A Financing for Pharma Processing Products
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China-based Alioth Biotech (Shanghai) Co., Ltd has raised close to RMB 100 million (USD 13.9 million) in a Series A financing round. The round was led by Matrix Partners and Legend Capital, with participation from Shanghai Yishuishan Enterprise Consulting Partnership Limited. The proceeds will be used to construct a membrane…
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HICOMP MicroTech Raises RMB 100M in Series B+ Financing for Microfluidics Expansion
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China-based micro/nano technology developer HICOMP MicroTech (Suzhou) Co., Ltd has raised RMB 100 million (USD 13.9 million) in a Series B+ financing round. The round was led by Shunwei Capital, with contributions from IC Space’s industrial investment platform. The proceeds will be used to support microfluidics research and development (R&D),…
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Kintor’s Dual c-Myc/GSPT1 Degradation Therapy GT19715 Shows Promise in Pre-Clinical Studies
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has published positive results from a pre-clinical study of its dual c-Myc/GSPT1 degrader GT19715 in acute myeloid leukemia (AML) and lymphomas. The findings highlight the potential of GT19715 as a targeted therapy for these challenging cancers. Pre-Clinical Study ResultsCell-free, cellular assays, and animal studies…
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CARsgen’s BCMA-Targeted CAR-T Therapy CT053 Gains Priority Review in China
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The Center for Drug Evaluation (CDE) website indicates that China-based chimeric antigen receptor (CAR)-T cell specialist CARsgen Therapeutics Holdings Ltd’s (HKG: 2171) B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy CT053 (zevor-cel) is set for priority review. This status relates to a market approval filing to treat adult patients with recurrent…
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LianBio Cancels Phase III Trial for Truseltiq in China Amid Global Halt
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China-based LianBio (OTCMKTS: LIANY) revealed in an SEC filing that it is canceling work on a Phase III trial in China for Truseltiq (infigratinib). The decision follows an announcement by BridgeBio Pharma Inc. (NASDAQ: BBIO), the drug’s discoverer, that the ongoing global Phase III PROOF-301 trial is being closed. This…
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Accutar Biotechnology Initiates Phase I Trial for ERα Targeting Degradation Molecule AC0682
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New Jersey-based Accutar Biotechnology Inc., which is heavily backed by Chinese funds, has announced the first patient dosing in a Phase I trial for AC0682, an orally bioavailable chimeric degrader molecule targeting the ERα protein. The molecule, which previously entered a Phase I study in the US, is the firm’s…
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CDE Releases Draft Guidelines for Extrapolating Adult Drug Data to Pediatric Use
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The Center for Drug Evaluation (CDE) has released the “Guidelines on Quantitative Methodology for Extrapolating Adult Drug Use Data to Pediatric Populations” (draft proposal), soliciting public feedback. This initiative aims to address the challenges in pediatric drug development by leveraging existing adult data to optimize the research and development process…
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RemeGen’s Telitacicept Receives FDA Orphan Drug Designation for Myasthenia Gravis
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China-based pharma firm RemeGen (HKG: 9995, SHA: 688331) has announced receiving Orphan Drug Designation (ODD) status from the US FDA for its fusion protein drug telitacicept in myasthenia gravis (MG). This designation highlights the potential of telitacicept in treating this rare and chronic autoimmune disease. The drug previously concluded a…
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Jacobio Partners with Merck KGaA for KRAS G12C Inhibitor Clinical Study
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China-based Jacobio Pharmaceuticals Group Co., Ltd (HKG: 1167) has announced a clinical study collaboration partnership with German giant Merck KGaA (ETR: MRK). The focus of the study is the combination of Jacobio’s KRAS G12C inhibitor JAB-21822 with Merck’s cetuximab in KRAS G12C mutant colorectal cancer (CRC). This partnership aims to…
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Hotgen Biotech Gains Regulatory Approvals in Saudi Arabia and India
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China-based Hotgen Biotech Co., Ltd (SHA: 688068) has announced receiving one certificate from the Saudi Food & Drug Authority (SFDA) and six certificates from the Drugs Controller General of India (DCGI) for its in-house developed products. These approvals mark significant milestones in the company’s global expansion efforts. Saudi Arabia ApprovalSpecifically,…
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BeiGene’s Brukinsa Outperforms Imbruvica in Phase III ALPINE Study
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) demonstrated superior progression-free survival (PFS) in the Phase III ALPINE study compared to Johnson & Johnson’s Imbruvica (ibrutinib). The 12-month PFS rate for Brukinsa was 94.9%, compared to 84%…
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Hengrui Medicine’s Deputy GM Tao Weikang Resigns, Joins Qilu Pharma
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its deputy general manager Tao Weikang has resigned, citing personal reasons, effective immediately. According to Healthcare Executive, Tao has joined Qilu Pharmaceutical Co., Ltd, to serve as the Shandong-based company’s vice-president and global novel drug research and development (R&D)…
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Proxinse Medtech Raises Series A Funding for Endoscope Camera System
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Shenzhen Proxinse Medical Technology Co., Ltd, a provider of minimally invasive surgery endoscope camera systems based in China, has reportedly raised “tens of millions” of renminbi in a Series A financing round. The round was led by Guangdong Technology Financial Group, with participation from Shenzhen HTI Group and Zhongshan Huoju…
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AlphaLife Sciences Raises Series A+ Funding for Clinical Research SaaS
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China-based clinical research SaaS service provider AlphaLife Sciences has reportedly raised “tens of millions” of US dollars in a Series A+ financing round. The round was led by Hankang Capital, with participation from B Capital. The proceeds will be used to further develop and expand the company’s next-generation clinical study…
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Aosaikang’s Neratinib Maleate API Market Filing Accepted by NMPA
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced that the market filing for its neratinib maleate active pharmaceutical ingredient (API) has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the company’s efforts to bring this important drug to the…
