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Huadong Medicine’s DR10624 Receives NMPA Approval for MAFLD and MASH Clinical Trials
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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’s HDM1005 Receives FDA Approval for MASH Clinical Study
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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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NucMito and Amoytop Biotech Seal Deal for Development and Commercialization of NASH Drug Candidate in Greater China
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NucMito, a pioneering nuclear receptor drug developer headquartered in Xiamen, has entered into a licensing agreement with fellow Chinese firm Xiamen Amoytop Biotech Co., Ltd (SHA: 688278). The agreement, valued at up to RMB 145 million (approximately USD 20.37 million) in upfront and milestone payments, as well as royalties, grants…
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Kanghong Pharmaceutical’s NASH Drug KH629 Approved for Clinical Trials in China
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Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its Category 1 chemical drug KH629, which is intended for the treatment of adult non-alcoholic steatohepatitis (NASH). This development follows the…
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Ascletis Pharma Faces US Import Ban for NASH Drugs ASC41 and ASC43F in Trade Secrets Dispute
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China’s Ascletis Pharma Inc. (HKG: 1672) is navigating legal proceedings involving its oral thyroid hormone receptor-beta (THRβ) agonist ASC41 and a compound preparation ASC43F, both under development for the treatment of non-alcoholic steatohepatitis (NASH). US-based Viking Therapeutics (NASDAQ: VKTX) filed a lawsuit in the United States against Ascletis in December…
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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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Hinova Pharmaceuticals’ HP515 Receives NMPA Approval for NASH Clinical Study
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Hinova Pharmaceuticals Inc., a biotech firm headquartered in Chengdu and listed on the Shanghai Stock Exchange (SHA: 688302), has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 chemical drug candidate, HP515. The molecule is intended for the treatment of nonalcoholic…
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Amoytop Biotech Opts for NASH Drug Candidate KN069 in Licensing Deal with Alphamab Oncology
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Xiamen Amoytop Biotech Co., Ltd (SHA: 688278), a biopharmaceutical company based in China, has exercised its option rights for KN069, a drug candidate for non-alcoholic steatohepatitis (NASH), under a licensing agreement with fellow Chinese firm Alphamab Oncology (HKG: 9966). The original deal, signed in December 2023, granted Amoytop the choice…
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Rona Therapeutics Secures USD 35 Million in Series A+ Round to Advance Nucleic Acid Therapies
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Rona Therapeutics, a Shanghai-based nucleic acid drug developer, has secured USD 35 million in a Series A+ financing round led by LongRiver Investments. The funding round also saw participation from Zhaode Investment, Zhongqi Capital, BioTrack Capital, and Lilly Asia Ventures. The company plans to utilize the proceeds to accelerate its…
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Moon Biotech Secures Exclusive State-Owned Fund Investment in Series C+ Round
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Moon (Guangzhou) Biotech Co., Ltd, a leading microbiome platform company based in China, has reportedly secured RMB 300 million (USD 41.3 million) in a Series C+ financing round. The funding was exclusively provided by SDIC JULI Investment, a state-owned investment fund. Established in 2015, Moon is recognized for possessing the…
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CSPC Pharmaceutical’s βKlotho Monoclonal Antibody JMT202 Receives Clinical Trial Approval from NMPA
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its βKlotho monoclonal antibody (mAb), JMT202. This molecule is intended to reduce triglyceride (TG) levels in patients…
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89bio Partners with BiBio Biopharma to Build API Facility for Pegozafermin in China
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U.S. biotechnology company 89bio (NASDAQ: ETNB) has secured the services of China-based Contract Development and Manufacturing Organization (CDMO) BiBio Biopharma Engineering to construct an API facility in China. The facility will supply the active pharmaceutical ingredient (API) for 89bio’s lead pipeline candidate, pegozafermin, an investigational FGF21 analog currently in Phase…
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Sino Biopharmaceutical Advances Lanifibranor and TQA2225 into Late-Stage Clinical Trials for MASH
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading biopharmaceutical company based in China, has announced the commencement of Phase III and Phase II clinical studies for two of its drug candidates. Lanifibranor, a PPAR agonist, and TQA2225, an FGF21-Fc fusion protein, are both being evaluated as potential treatments for metabolic dysfunction-associated…
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Boehringer Ingelheim Partners with Suzhou Ribo Life Science to Develop siRNA Therapies for NASH/MASH
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Boehringer Ingelheim (BI), a Germany-headquartered pharmaceutical company, has entered into a collaboration agreement with Suzhou Ribo Life Science Co., Ltd, a Chinese biotechnology firm, to co-develop small interfering RNA (siRNA) drugs for the treatment of non-alcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH). This strategic partnership aims to leverage Ribo’s proprietary RIBO-GalSTAR…
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Ascletis Pharma’s ASC41 Shows Promising Results in Phase II NASH Study
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Ascletis Pharma Inc. (HKG: 1672), a Chinese pharmaceutical company, has announced positive interim results from a 52-week Phase II study evaluating the efficacy of the thyroid hormone receptor β (THRβ) agonist ASC41 in patients with liver biopsy-proven non-alcoholic steatohepatitis (NASH). The ongoing, randomized, double-blind, placebo-controlled, and multi-center Phase II study…
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Chengdu Kanghong Pharmaceutical’s KH629 Receives FDA Approval for NASH Clinical Trial
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Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its Category 1 chemical drug, KH629, which is intended for the treatment of non-alcoholic steatohepatitis (NASH). KH629’s Profile and Previous…
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Novo Nordisk Halts Phase III Ozempic Study on Renal Impairment in Diabetes Patients
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Denmark-based pharmaceutical giant Novo Nordisk (NYSE: NVO) has decided to discontinue a Phase III global study evaluating the impact of the GLP-1 receptor agonist Ozempic (semaglutide) on the progression of renal impairment in individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD). The decision was recommended by an…
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Tasly Pharmaceuticals Gets NMPA Approval for B1344 Clinical Study in NASH
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Tasly Pharmaceuticals (SHA: 600535), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its human fibroblast growth factor 21 injection, B1344, in patients with non-alcoholic steatohepatitis (NASH). This development marks a significant step in the…
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Hepagene Therapeutics’ HPG7233 Receives US FDA IND Approval for NASH Treatment
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Hong Kong-based biopharmaceutical company Hepagene Therapeutics Inc. has announced that the US Food and Drug Administration (FDA) has granted an Investigational New Drug (IND) approval for its drug candidate, HPG7233. This small-molecule thyroid hormone receptor beta (THR-β) agonist is poised for development as a treatment for non-alcoholic steatohepatitis (NASH) and…
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United Laboratories’ UBT251 Receives Tacit Approval for NAFLD Clinical Study in China
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Hong Kong firm United Laboratories International Holdings Ltd (HKG: 3933) has announced that its Category 1 drug candidate UBT251 has been tacitly approved in China for a clinical study focusing on non-alcoholic fatty liver disease (NAFLD). UBT251: A Triple Agonist for Metabolic ImprovementsUBT251 is a long-acting GLP-1 (glucagon-like peptide-1)/GIP (glucose-dependent…
