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Sichuan Kelun’s KL340399 Wins NMPA Approval for Solid Tumor Trials
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its next-generation small-molecule STING agonist, KL340399. The approval allows the company to proceed with trials for locally advanced, recurrent, or metastatic solid tumors suitable for intratumoral injection. Drug Mechanism…
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WinHealth Pharma and Ferring Partner to Co-Promote Pentasa in China
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China-based Hong Kong WinHealth Pharma Group Ltd has entered into a new partnership with Switzerland-headquartered Ferring Pharmaceuticals Ltd, this time securing co-promotion rights for Ferring’s Pentasa (mesalazine) in mainland China. This collaboration follows previous joint efforts on terlipressin and desmopressin. Partnership DetailsUnder the terms of the agreement, WinHealth Pharma will…
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WuXi ATU Partners with Wugen to Accelerate NK Cell Therapy Development
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WuXi ATU, the gene and cell therapy-focused CTDMO unit of WuXi Apptec (SHA: 603259, HKG: 2359), has formed a partnership with US clinical biotech firm Wugen, Inc. This collaboration centers on Wugen’s immunotherapy candidate WU-NK-101, with WuXi ATU providing Good Manufacturing Practice (GMP)-compliant manufacturing and testing services to support regulatory…
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Jiangsu Hengrui Medicine’s SHR4640 Receives NMPA Approval for Gout Trial
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 innovative gout drug SHR4640. The study will evaluate the drug in combination with febuxostat for hyperuricemia in gout patients. Drug MechanismSHR4640 is…
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Beijing Aosaikang’s ASKG315 Receives NMPA Approval for Solid Tumor Trial
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) announced that its clinical trial application for ASKG315, an in-house developed recombinant human interleukin-15 prodrug Fc fusion protein, has been accepted by China’s National Medical Products Administration (NMPA). This marks a significant milestone for the company’s oncology pipeline. Drug Mechanism and InnovationASKG315 is…
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Jacobson Pharma Leads HKD 6 Million JV for Specialty Drug Distribution
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China-based Jacobson Pharma Corporation (HKG: 2633), Ban Loong Holdings Ltd (HKG: 0030), and JBM (Healthcare) Limited (HKG: 2161) are set to establish a joint venture (JV) with a capital of HKD 6 million (USD 764,361). The companies will hold stakes of 20%, 60%, and 20% respectively. The JV aims to…
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Hansoh Pharmaceutical’s Ameile Accepted for UK Regulatory Review
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that a Marketing Authorization Application (MAA) for its epidermal growth factor receptor (EGFR) inhibitor Ameile (almonertinib) has been accepted for review by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The application seeks approval for Ameile as a first-line treatment…
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MegaRobo Secures USD 300 Million in Series C Round Led by Goldman Sachs
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Beijing-based MegaRobo Technologies, a company applying robotics and artificial intelligence (AI) in the life sciences field, has reportedly secured USD 300 million in a Series C financing round. The funding was led by Goldman Sachs, GGV Capital, and Asia Investment Capital, with participation from Sinovation Ventures, Pavilion Capital, Starr Capital,…
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China Issues Monkeypox Diagnosis Guidelines Amid Global Outbreaks
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China’s National Health Commission (NHC) has formulated and released the “Monkeypox Diagnosis and Treatment Guidelines” (2022 Edition) in response to the recent outbreaks of monkeypox in multiple non-pandemic countries since May this year. The guidelines aim to enhance early clinical identification and standardized diagnosis and treatment, ensuring thorough preparedness against…
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Quoin Pharmaceuticals Partners with WinHealth for Rare Disease Treatments in Greater China
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US-based rare disease specialist Quoin Pharmaceuticals Ltd (NASDAQ: QNRX) announced a licensing and distribution agreement with Hong Kong WinHealth Pharma Group Ltd. The deal grants WinHealth rights to Quoin’s pipeline candidates QRX003 and QRX004 for Netherton syndrome and epidermolysis bullosa (EB) in the Greater China territory, including Hong Kong, Macau,…
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US Bipartisan Bill Seeks to Regulate Investments in Chinese High-Tech Firms
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US senators are preparing a bipartisan bill that would require US investors targeting Chinese high-tech companies, including those in the pharmaceutical sector, to seek government approval in the future. The draft proposals are part of an economic competitiveness bill aimed at countering China’s rise. Proposed MechanismThe proposals would establish a…
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Alphamab Oncology Doses First Patient in Phase I Trial for PD-L1/OX40 Bispecific Antibody KN052
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China-based Alphamab Oncology (HKG: 9966) has announced the dosing of the first patient in a Phase I clinical trial in China (KN052-CHN-001) for its pipeline candidate KN052. This bispecific antibody (BsAb) targets programmed-death ligand 1 (PD-L1) and OX40 and is being evaluated as a treatment for general advanced solid tumors.…
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Walvax Biotechnology Halts EV71 Vaccine Development Amid Changing Disease Trends
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced the decision to terminate a clinical study and end development for its recombinant enterovirus 71 (EV71) virus vaccine (Pichia pastoris). The company’s press release states that the recombinant EV71 vaccine, which first entered clinical trials in China in June 2019, was…
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Jiangsu Hengrui Medicine’s Hetrombopag Olamine Receives FDA Orphan Drug Designation for ITP
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received orphan drug designation (ODD) status from the US FDA for its hetrombopag olamine as a treatment for primary immune thrombocytopenia (ITP). The drug was approved in China in June 2021 for the treatment of ITP in…
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WuXi AppTec Faces Shareholder Divestment of Up to 3% Stake
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China-based Contract Research Organization (CRO) WuXi AppTec Co., Ltd (SHA: 603259, HKG: 2359) has disclosed that a group of shareholders plans to divest up to 3% of their holdings in the company. This translates to the auctioning of up to 88.68 million A shares in blocks, representing RMB 9.12 billion…
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Zai Lab Ltd Makes FcRn Antagonist Efgartigimod Available for Myasthenia Gravis Treatment
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Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced the availability of efgartigimod, the world’s first FcRn antagonist, via the Bo’Ao Lecheng Medical Tourism Pilot Zone for the treatment of myasthenia gravis (MG). Understanding Myasthenia GravisMyasthenia gravis is a rare and chronic autoimmune disease caused by the dysfunction of nerve…
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Bristol-Myers Squibb Launches Reblozyl in China for β-Thalassemia Treatment
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US pharmaceutical giant Bristol-Myers Squibb (BMS; NYSE: BMY) has announced the commercial launch of its first-in-class erythrocyte maturation agent, Reblozyl (luspatercept), in China. The product, filed by its subsidiary Celgene, received approval in China in January 2022 for the treatment of adult β-thalassemia patients who require regular red blood cell…
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China NT Pharma Group Company Ltd Inks Licensing Deal for Monoclonal Antibodies
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China-based China NT Pharma Group Company Ltd (HKG: 1011) has announced a potential acquisition agreement with an undisclosed US firm. Under the terms of the agreement, its wholly owned subsidiary, Green-Life Technology (Hong Kong) Co., Ltd, will obtain exclusive and permanent commercial licensing rights to several monoclonal antibodies (mAbs) for…
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Clover Biopharmaceuticals Initiates SCB-219M Clinical Study for CIT Treatment
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China-based Clover Biopharmaceuticals Ltd (HKG: 2197) has announced the first subject dosing in a Phase I clinical study for its in-house developed thrombopoietin receptor agonist, SCB-219M. This multi-center, dosage escalation and expansion study will evaluate the safety, tolerability, immunogenicity, pharmacokinetic characteristics, and efficacy of SCB-219M in CIT patients. Interim safety…
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Changchun High & New Technology’s Jinnamab Approved for AOSD Clinical Study by US FDA
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China-based Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) has announced that it has received approval from the US FDA to conduct a clinical study for its jinnamab in adult-onset still disease (AOSD). Understanding AOSDAOSD, originally referring to the systemic onset of juvenile chronic arthritis, can also occur…
