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China’s generative artificial intelligence (AI)-driven biotech company, Insilico Medicine, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its potential best-in-class ENPP1 inhibitor, ISM5939, in solid tumors. ISM5939: A Promising ENPP1 InhibitorISM5939 targets ENPP1, an external nucleotide pyrophosphatase…
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China-based Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has announced the enrollment of the first patient in the Phase I study for its 20-valent pneumococcal polysaccharide conjugate vaccine. This vaccine is designed to prevent infectious diseases caused by 20 pneumococcal serotypes, targeting infants and children aged between 2 months…
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that it has received clearance from the National Medical Products Administration (NMPA) in China for a clinical trial filing of its pipeline candidate, SKB501. The novel antibody drug conjugate (ADC) is now set to be assessed in the treatment of advanced…
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China-based Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a leading provider of cardiovascular disease solutions, has announced that it has received clinical approvals from the National Medical Products Administration (NMPA) for its innovative therapies, MWN109 and MWN105. Both treatments are indicated for overweight or obesity and type 2 diabetes,…
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China-based GeneQuantum Healthcare, a leading developer of antibody drug conjugates (ADCs), has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for GQ1011 (AMB302). This FGFR3-targeted ADC was co-developed with South Korea-based biotech Aimed Bio under an agreement established in…
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Shanghai Henlius Biotech Co., Ltd (HKG: 2696) has announced the dosing of the first patient in a global, multi-center Phase III study for its drug candidate HLX22. The study will compare the combination of HLX22 with trastuzumab and chemotherapy against the same regimen with or without pembrolizumab in the first-line…
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Shanghai-based cell therapy specialist Base Therapeutics has achieved clearance from the US Food and Drug Administration (FDA) to study its NK510 in advanced solid tumors, following clinical approval in China last month. This development marks a significant step forward for the company’s base-edited universal NK cell therapy. NK510: A Leap…
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China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its biosimilar version of Denmark-based Novo Nordisk’s (NYSE: NVO) weight loss drug semaglutide, which is marketed as Ozempic and Wegovy. The product is set to…
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the first patient dosing in an open, multi-center Phase II study. The study is designed to assess the safety and efficacy of its investigational drugs ABSK061 combined with ABSK043, with or without chemotherapy, in patients with metastatic or unresectable solid…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its investigational drug HRS-6208 as a monotherapy for solid tumors. HRS-6208: A Selective Small Molecule InhibitorThe drug, a selective small molecule inhibitor with…
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Apeiron Therapeutics, a biomarker-driven cancer therapy developer with operations in Shanghai, China, and San Francisco, US, has announced the enrollment of the first patient in the Phase Ia/B study for its investigational drug GTA182. The dosage escalation study aims to assess the safety, efficacy, and pharmacokinetics of the small molecule…
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China’s Betta Pharmaceuticals (SHE: 300558) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate, MCLA-129. The upcoming trial will evaluate the biologic product as a potential treatment for advanced solid tumors, including wild-type colorectal cancer, liver cancer,…
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Holland-based Xeltis AG has announced the enrollment of the first patient in a US-staged pivotal trial for its flagship product, aXess, which has been granted Breakthrough Device Designation (BTD) status by the US FDA. This marks a significant milestone in the development and potential approval of aXess, a novel medical…
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical trials for its protein drug DR10624 in metabolic related fatty liver disease (MAFLD) and metabolic associated steatohepatitis (MASH). DR10624’s Mechanism and Pre-Clinical PerformanceDR10624 is a…
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Huadong Medicine Co., Ltd (SHE: 000963), a China-based pharmaceutical company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its Category 1 chemical drug, HDM1005, in metabolic associated steatohepatitis (MASH). This development marks a significant step forward for…
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Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392), a leading Chinese pharmaceutical company, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its nine-valent human papillomavirus (HPV) vaccine (Escherichia coli), specifically designed for the male population. Global Impact and Vaccine RelevanceGlobally, approximately…
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China-based Hasten Biopharmaceutical Co., Ltd, a comprehensive biopharmaceutical company co-established by CBC Group, has announced the first subject dosing in its Phase III clinical study for lerodalcibep, a third-generation PCSK9 inhibitor. The drug was in-licensed from US firm LIB Therapeutics Inc. in September of the previous year. Study Design and…
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China-based biopharmaceutical company CanSino Biologics (HKG: 6185) has announced the commencement of a Phase I clinical study for its freeze-dried Haemophilus influenzae type b (Hib) conjugate vaccine, marking a significant step in the development of this important pediatric vaccine. The study has begun with the enrollment of the first subject,…
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a leading biopharmaceutical company based in China, has announced receiving separate Investigational New Drug (IND) approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugates (ADCs), SKB535 and SKB571, which target solid tumors. This development marks a significant milestone in…