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Enhertu (trastuzumab deruxtecan), an HER2-targeted antibody-drug conjugate co-developed by AstraZeneca (NASDAQ: AZN, LON: AZN) and Daiichi Sankyo (TYO: 4568), has received conditional approval in China for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ) who have undergone two or more…
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Novartis Inc. (NYSE: NVS) is intensifying its efforts to thwart the entry of generic competitors for its heart failure and hypertension medication, Entresto (valsartan + sacubitril), following the U.S. FDA’s approval of a generic version from India-based MSN Laboratories on July 24. A federal court judge in Delaware recently denied…
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Beijing Wantai Biological Pharmacy Enterprise Co., Ltd (SHA: 603392) has announced that its nine-valent recombinant human papillomavirus (HPV) vaccine, co-developed with Xiamen University, has received priority review status from China’s Center for Drug Evaluation (CDE). This vaccine targets seven high-risk HPV types (HPV16, 18, 31, 33, 45, 52, and 58)…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical trial for its investigational drug SHR7280, aimed at treating heavy menstrual bleeding associated with uterine fibroids. SHR7280 is an oral small molecule…
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GSK (NYSE: GSK), the UK-based pharmaceutical giant, has registered a Phase III bridging study for its recombinant RSV vaccine in China on ClinicalTrials.gov. The vaccine, which received marketing approval in the U.S. in May 2023, will undergo a study that aims to complete its primary endpoint follow-up by March 2025.…
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Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has secured separate marketing approvals from China’s National Medical Products Administration (NMPA) for its biosimilars of Novo Nordisk (NYSE: NVO)’s Tresiba (insulin degludec) and Ryzodeg (insulin degludec and insulin aspart), both of which are indicated for the treatment of type 2 diabetes. These…
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The China Center for Drug Evaluation (CDE) has accepted for review a market approval filing for Pfizer Inc.’s (NYSE: PFE) Category 1 biologic drug marstacimab (PF-06741086), according to the agency’s website. This regulatory milestone in China follows similar submissions to the U.S. Food and Drug Administration (FDA) and the European…
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced a new indication filing with Chinese regulators for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The company is pursuing marketing approval for Loqtorzi as a first-line therapy for patients with unresectable or metastatic melanoma, marking the twelfth indication filing…
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Nanjing Sanhome Pharmaceutical Co., Ltd, a notable player in the pharmaceutical sector, has announced the widespread distribution of its Category 1 chemical drug, oritinib, across key regions in China, including Jiangsu, Shanghai, Beijing, Henan, and Inner Mongolia. The drug has been made available to lung cancer specialists who are now…
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Boehringer Ingelheim, a leading German pharmaceutical company, has received a significant endorsement from China’s Center for Drug Evaluation (CDE) with the breakthrough therapy designation (BTD) for its investigational HER2-targeted tyrosine kinase inhibitor (TKI), zongertinib (BI 1810631). This designation underscores the potential of zongertinib in treating adult patients with HER2-mutated advanced,…
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IASO Biotherapeutics, a Chinese biotech firm, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to commence trials of its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Fucaso (equecabtagene autoleucel), for the treatment of non-renal systemic lupus erythematosus (SLE) and systemic lupus nephritis…
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This week, the U.S. Food and Drug Administration (FDA) granted market approval to Ascendis Pharma A/S (NASDAQ: ASND), a Denmark-based pharmaceutical company specializing in rare diseases, for its hypoparathyroidism treatment, palopegteriparatide. The therapy, to be marketed as Yorvipath, is a once-daily prodrug of parathyroid hormone (PTH[1-34]) designed to address the…
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Pfizer Inc. (NYSE: PFE), a pharmaceutical titan based in the US, has announced encouraging topline results from a sub-study within its ongoing Phase III clinical trial (NCT05842967) for Abrysvo, a vaccine designed to combat respiratory syncytial virus (RSV). The data indicate that Abrysvo offers robust protection against RSV infections in…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received additional indication approval from the National Medical Products Administration (NMPA) for its generic version of Abraxis BioScience’s Abraxane (paclitaxel, albumin-bound). The drug is now approved for use in combination with gemcitabine…
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative therapy, SYS6020. This therapy is a BCMA-targeted chimeric antigen receptor (CAR)-T cell treatment designed for systemic lupus erythematosus (SLE),…
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062), a biopharmaceutical company based in China, has announced that its antibody drug conjugate (ADC), 9MW2821, which targets Nectin-4, is on track to receive breakthrough therapy designation (BTD) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the…
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has announced that its Phase III clinical study for the drug candidate SSGJ-608 has successfully met all primary endpoints (PASI 75 and sPGA 0/1), key secondary efficacy endpoints (PASI 90, PASI 100, and sPGA 0), and all…
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Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317), a pharmaceutical company based in China, has announced that it has obtained marketing approval for its drug Yueruiling (leritrelvir) in Macau. The drug, a 3CL protease (3CLpro) inhibitor, is now authorized for use in treating mild to moderate cases of COVID-19. Leritrelvir functions…
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has announced that its Phase II clinical study for SSGJ-611, an IL-4Rα monoclonal antibody (mAb) candidate for chronic sinusitis with nasal polyps (CRSwNP), has met its primary endpoint. The study demonstrated the efficacy and safety of SSGJ-611…