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Haisco Pharmaceutical’s HSK31679 Receives Clinical Trial Approval for NASH Treatment
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that its in-house developed Category 1 drug candidate, HSK31679, has obtained clinical trial approval for the treatment of non-alcoholic steatohepatitis (NASH). HSK31679: A Selective THR-β Agonist for Lipid MetabolismHSK31679 is a highly selective thyroid hormone β receptor (THR-β) agonist that…
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NMPA Approves XZenith Biopharm’s Anaprazole for Duodenal Ulcer Treatment
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The National Medical Product Administration (NMPA) has granted marketing approval for anaprazole, a proton pump inhibitor (PPI) developed by China-based XZenith Biopharm. This home-grown Category 1 drug is now approved for use in treating duodenal ulcers. Anaprazole’s Mechanism of Action and Clinical AdvantagesAnaprazole, a benzimidazole compound, functions by inhibiting gastric…
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Sichuan Kelun’s SKB264 Earns Breakthrough Therapy Designation for Breast Cancer Treatment
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The Center for Drug Evaluation (CDE) website has indicated that China-based Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) antibody-drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has obtained breakthrough therapy designation (BTD) status. This designation is for use in locally advanced or metastatic hormone receptor positive and HER2…
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Shionogi’s Acquisition of Qpex Impacts Brii Biosciences’ Rights to Anti-infective Drugs
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Japan’s Shionogi & Co., Ltd (TYO: 4507) announced on June 26, 2023, its planned acquisition of US anti-infectives specialist Qpex Biopharma Inc., for USD 100 million upfront and an additional USD 40 million based on certain development and regulatory milestones. This deal has significant implications for China-based biotech Brii Biosciences…
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Innovent Biologics and RemeGen Partner on Clinical Study for PD-1 Inhibitor and ADC Drugs
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China-based Innovent Biologics Inc., (HKG: 1801) has entered into a clinical study and supply cooperation agreement with compatriot firm RemeGen (HKG: 9995). The collaboration will pair Innovent’s programmed death-1 (PD-1) inhibitor Tyvyt (sintilimab injection) with RemeGen’s antibody drug conjugate (ADC) drug candidates RC88 and RC108 in a clinical study. Clinical…
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Sino-Cuban JV Biotech Pharmaceutical Receives NMPA Approval for Nimotuzumab in Pancreatic Cancer
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Sino-Cuban joint venture (JV) Biotech Pharmaceutical Limited (BPL) announced last week that it has received an indication extension from China’s National Medical Products Administration (NMPA) for its biologic drug nimotuzumab. This new approval marks an expansion of the drug’s use beyond its original authorization in nasopharyngeal carcinoma (NPC) to now…
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Sarepta Therapeutics’ Elevidys Receives FDA Accelerated Approval for Duchenne Muscular Dystrophy
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US-based Sarepta Therapeutics, Inc. (NASDAQ: SRPT) has announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Elevidys (delandistrogene moxeparvovec-rokl), an adeno-associated virus-based gene therapy co-developed by Roche. This treatment is designed for ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD)…
