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The official website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has indicated that Daiichi Sankyo (TYO: 4568)’s pexidartinib (PLX3397) is on track to receive priority review status for the treatment of symptomatic giant cell tumor of the tendon sheath (TGCT) in adult patients…
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AbbVie (NYSE: ABBV), a leading pharmaceutical company based in the U.S., has announced a licensing agreement with Gedeon Richter Plc, aimed at strengthening the development of new potential targets for neuropsychiatric conditions. This collaboration builds upon the nearly two decades of successful partnership on central nervous system (CNS) projects, which…
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Asieris Pharmaceuticals (SHA: 688176), a China-based specialist in urogenital cancer treatments, has announced that it has received clinical clearance from the U.S. Food and Drug Administration (FDA) for its in-house developed ubiquitin specific peptidase 1 (USP1) inhibitor, APL-2302, for the treatment of advanced solid tumors. Preclinical studies have indicated that…
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced the dosing of the first patient in a global, multi-center Phase III study for its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab, HLX10). The study combines serplulimab with bevacizumab and chemotherapy for the first-line treatment of…
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541), a Chinese biopharmaceutical company, has announced the first patient in (FPI) for a Phase Ib clinical study of its dual-target macromolecular drug amulirafusp alfa (IMM0306) in the treatment of moderate to severe systemic lupus erythematosus (SLE). This marks a significant advancement in the…
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Sanofi (NASDAQ: SNY), the French pharmaceutical giant, has announced the presentation of new data from the Phase III LIBERTY-CUPID Study C for its drug Dupixent (dupilumab) in the treatment of chronic spontaneous urticaria (CSU) at the American College of Allergy, Asthma and Immunology (ACAAI) 2024 annual meeting. The LIBERTY-CUPID Study…
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Shanghai Haihe Pharmaceutical Co., Ltd and 3SBio Inc. (HKG: 1530), two Chinese pharmaceutical companies, have jointly announced a licensing agreement that grants 3SBio the exclusive rights to commercialize Haihe’s paclitaxel oral solution in mainland China and Hong Kong. According to the agreement, 3SBio will pay an undisclosed upfront sum along…
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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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HELP Therapeutics Co. Ltd, a clinical-stage cell therapy company headquartered in Nanjing, has announced that it has received clearance from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its allogeneic human induced pluripotent stem cell-derived cardiomyocytes (HiCM-188). This treatment involves administration via intramyocardial…
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Merck, Sharp & Dohme Inc. (MSD; NYSE: MRK), a leading U.S. pharmaceutical company, has bolstered its oncology pipeline through the acquisition of Modifi Biosciences, Inc., a biotechnology company specializing in direct DNA modification-enabled cancer therapeutics. This strategic move provides MSD with preclinical compounds aimed at exploiting DNA repair defects in…
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Eli Lilly & Co. (NYSE: LLY) has announced that it has received marketing approval in Great Britain for Kisunla (donanemab), an Alzheimer’s disease (AD) treatment. Kisunla is an intravenous infusion administered every four weeks to eligible adults with mild cognitive impairment and mild dementia due to AD. Eligibility is restricted…
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Sino Medical Sciences Technology Inc., (SHA: 688108) a China-based medical device company, has announced that it has received marketing approval in Morocco for its SC HONKYTONK coronary balloon dilation catheter. This product, designed for balloon catheter dilation of narrowed segments or bridging sites in coronary arteries to enhance myocardial perfusion,…
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Gan & Lee Pharmaceuticals (SHA: 603087), a Chinese pharmaceutical company, has announced the commencement of a Phase I clinical study for GLR1023, a biosimilar candidate to Novartis’ Cosentyx (secukinumab). The company has recently dosed the first patient in the trial, which is focused on evaluating the safety and efficacy of…
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Vyepti (eptinezumab), a migraine treatment developed by Denmark-based biopharmaceutical company H. Lundbeck A/S (OTCMKTS: HLBBF), has been introduced at Sun Yat-sen Memorial Hospital, Sun Yat-sen University, facilitated by the “Hong Kong-Macau Drug and Device Access” policy. This policy, part of the broader Greater Bay Area initiative, enables patients to access…
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a China-based pharmaceutical company, through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced positive top-line results from the Phase III China CHAMP study for NVK002, an atropine external use eye solution designed to address myopia progression. The Phase III study, a randomized, double-blinded,…
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Sino-US firm Eccogene Inc. announced on October 23rd that it is set to receive a $60 million payment from AstraZeneca (AZ, NASDAQ: AZN) following the successful achievement of development milestones for ECC5004/AZD5004, including the dosing of the first patient in the Phase 2b trial. This payment is a part of…
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd (SHA: 688336), a subsidiary of 3SBio Inc. (HKG: 1530), has released its financial report for the third quarter of 2024. The company reported revenues of RMB 939 million (USD 131.8 million) for the period, marking a 28.58% increase year-on-year. The net profit attributable to…
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LINDIS Biotech GmbH, a German biotechnology company, has announced that the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) has issued positive opinions regarding Korjuny (catumaxomab). The trifunctional anti-CD3 x anti-EpCAM antibody (trAb) is recommended for the intraperitoneal treatment of malignant ascites (MA) in adults with…
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Beijing Biostar Technologies Ltd (HKG: 2563), a leading synthetic biology-driven anti-tumor drug specialist based in China, has successfully completed an initial public offering (IPO) on the Hong Kong Stock Exchange. The company issued 14,588,000 shares at a price of HKD 22 each, raising a total of HKD 320 million (USD…
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China Grand Pharmaceutical and Healthcare Holdings Ltd (CGP; HKG: 0512) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its adjustable intracranial thrombectomy stent, marking a significant milestone as the first domestically produced device of its kind in China for the treatment of…