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Yixintang Partners with Huawei Cloud to Drive Digital Transformation in Pharma Retail
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Yixintang Pharmaceutical Group Co., Ltd. (SHE: 002727), a prominent pharmaceutical retail chain in China, has entered into a strategic partnership with telecom giant Huawei Cloud. The collaboration aims to enhance information infrastructure, develop data-enabled platforms, and innovate within the burgeoning health industry, all while driving the digital and intelligent transformation…
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CARsgen Completes Patient Enrollment for Phase II Trial of CT041 in Advanced Gastric Cancer
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), a leading China-based developer of chimeric antigen receptor (CAR)-T cell therapies, has announced the completion of patient enrollment in a confirmatory Phase II clinical trial for its investigational CAR-T therapy, CT041. The study aims to evaluate CT041 as a potential treatment for advanced gastric…
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Kelun Pharmaceutical’s Sacituzumab Tirumotecan Receives Priority Review for NSCLC Treatment
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Sichuan Kelun Pharmaceutical Co., Ltd. (SHE: 002422) has announced that its drug sacituzumab tirumotecan (SKB264/MK-2870) has been granted priority review status by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). This designation is for the drug’s application as a treatment for locally advanced or metastatic…
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Lykos Therapeutics Faces Setback as FDA Rejects Midomafetamine for PTSD Treatment
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Lykos Therapeutics, a U.S.-based biotech firm, has expressed concern over the impact of the FDA’s August 9 decision to reject its New Drug Application (NDA) for midomafetamine (MDMA) as a treatment for post-traumatic stress disorder (PTSD) in adults. This ruling is seen as a pivotal moment for the emerging psychedelics…
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Chugai Seeks Approval for Elevidys Gene Therapy in Japan, Targeting Duchenne Muscular Dystrophy
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Chugai Pharmaceutical Co., Ltd. (TYO: 4519), a subsidiary of Roche, has submitted a product approval application in Japan for delandistrogene moxeparvovec, marketed globally as Elevidys, a gene therapy aimed at treating Duchenne muscular dystrophy (DMD). The therapy is specifically indicated for ambulatory boys aged 3 to 7 years with DMD…
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Staidson Launches Phase Ia Trial for STSP-0902 Injection in Oligoasthenozoospermia
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Staidson (Beijing) Pharmaceutical Co., Ltd. (SHE: 300204) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase Ia clinical trial for its STSP-0902 injection, targeting oligoasthenozoospermia. The randomized, double-blinded, placebo-controlled study aims to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of STSP-0902…
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Jiangsu Hengrui Secures NMPA Approval for Clinical Trials of SHR-2106 in Primary Sjögren’s Syndrome
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its investigational drug SHR-2106, targeting active primary Sjögren’s syndrome (pSS). Primary Sjögren’s syndrome is a chronic autoimmune disorder predominantly affecting middle-aged and elderly women, characterized by…
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Vimgreen Pharma Launches Phase II Trial for A2AR Antagonist VG081821AC in Parkinson’s Disease
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Zhejiang-based Vimgreen Pharma has announced the launch of a Phase II clinical trial for its innovative A2AR antagonist VG081821AC, targeting early to mid-stage Parkinson’s disease (PD). The company has successfully completed patient dosing for the study. This 12-week, multi-center, randomized, double-blinded trial aims to evaluate the safety and efficacy of…
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Gilead Secures FDA Accelerated Approval for Livdelzi in Liver Disease Treatment
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Gilead Sciences Inc. (NASDAQ: GILD) has received accelerated approval from the U.S. FDA for its liver disease treatment, Livdelzi (seladelpar), following its acquisition of CymaBay Therapeutics Inc. for $4.3 billion earlier this year. The FDA has authorized Livdelzi for use in combination with ursodeoxycholic acid (UDCA) to treat primary biliary…
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Astellas Pharma Secures UK Approval for First-in-Class Gastric Cancer Therapy Vyloy
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Astellas Pharma (TYO: 4503), a leading Japanese pharmaceutical company, has secured market approval in the UK for its first-in-class gastric cancer therapy, Vyloy (zolbetuximab), targeting Claudin18.2 (CLDN18.2). According to a press release from the Medicines and Healthcare products Regulatory Agency (MHRA), the approval allows Vyloy to be used as a…
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Shandong Buchang Pharmaceuticals Partners with Lancet for BC001 Licensing in Eurasia
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Shandong Buchang Pharmaceuticals Co., Ltd. (SHA: 603858), based in China, has announced plans to enter a licensing agreement with Russia’s Lancet Pharmaceuticals, granting the latter regulatory filing, commercialization, and other rights for Buchang’s pipeline candidate BC001 across the Eurasian Economic Union, which includes Russia, Belarus, Kazakhstan, Armenia, Kyrgyzstan, and Uzbekistan.…
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Biogen and Eisai Secure UAE Approval for Alzheimer’s Therapy Leqembi
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Biogen Inc. (NASDAQ: BIIB), based in the U.S., and Japan’s Eisai Co., Ltd. have announced that their Alzheimer’s disease therapy, Leqembi (lecanemab), has received approval in the United Arab Emirates (UAE) for the treatment of patients with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and/or mild AD dementia.…
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CStone to Manufacture Gavreto Locally Following NMPA Approval, Expanding Market Presence
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to locally manufacture its Gavreto (pralsetinib tablets, 100mg), transitioning from overseas supply. Domestic production is anticipated to begin by late this year or early next year, following the approval of the 300mg…
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Qilu Pharmaceutical Gains Approval for Generic Dasatinib, Expanding CML Treatment Options in China
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Qilu Pharmaceutical, based in China, has received marketing approval for its generic version of Bristol-Myers Squibb’s (BMS) Sprycel (dasatinib) in China. This second-generation BCR-ABL tyrosine kinase inhibitor (TKI) is now available for the treatment of patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) who are resistant to or intolerant…
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Ascentage Pharma Secures NMPA Approval for Phase III Trial of Lisaftoclax in MDS
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Ascentage Pharma (HKG: 6855), based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a multi-center, randomized, double-blind Phase III study evaluating the efficacy of its novel drug, lisaftoclax (APG-2575), in combination with azacitidine (AZA) for the first-line treatment of newly diagnosed patients with higher-risk…
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Enhertu Gains Conditional Approval in China for Advanced HER2-Positive Gastric Cancer
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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 Intensifies Legal Action Against FDA Over Entresto Generic Approval
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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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Wantai Biological’s HPV Vaccine Receives Priority Review from China’s CDE
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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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Hengrui Pharmaceuticals Launches Phase II Trial for SHR7280 to Treat Uterine Fibroids
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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 Initiates Phase III Study for RSV Vaccine in China Following U.S. Approval
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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.…
