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Yipinhong Pharmacy’s AR882 Earns FDA Fast-Track Status for Gout Treatment
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BEIJING—China-based Yipinhong Pharmacy Co., Ltd (SHE: 300723) has announced that its novel drug AR882 has received fast-track designation from the US Food and Drug Administration (FDA) for the treatment of visible tophi in patients with gout. This Category 1 drug, co-developed with US firm Arthrosi Therapeutics Inc., is a next-generation…
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Astellas Pharma’s Padcev Receives NMPA Approval for Urothelial Cancer Treatment
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TOKYO—Astellas Pharma Inc. (TYO: 4503) has announced that its anti-HER3 antibody-drug conjugate (ADC), Padcev (enfortumab vedotin), in partnership with Pfizer, has been granted approval by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who have received prior platinum-containing…
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BioNTech’s BNT326/YL202 Clears FDA Hurdle, Advancing in Clinical Trials for Solid Tumor Treatment
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FRANKFURT—BioNTech SE (NASDAQ: BNTX), a leading German biotechnology company, has announced that the US Food and Drug Administration (FDA) has lifted the partial clinical hold on its Phase I clinical trial for BNT326/YL202, an anti-HER3 targeted antibody drug conjugate (ADC). This development paves the way for the resumption of trials…
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Changchun High & New Technology Secures NMPA Approval for Turner Syndrome Treatment
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CHANGCHUN—Changchun High & New Technology Industries (Group) Inc., (SHE: 000661), a leading biopharmaceutical company in China, has announced that it has received additional indication approval from the National Medical Products Administration (NMPA) for its polyethylene glycol recombinant human somatropin. This long-acting somatropin is now approved for use in growth disorders…
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AstraZeneca’s Fasenra Secures NMPA Approval for Severe Eosinophilic Asthma Maintenance Therapy
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BEIJING—The National Medical Products Administration (NMPA) of China has granted market approval for AstraZeneca (NASDAQ: AZN, LON: AZN) ‘s Fasenra (benralizumab) as a maintenance therapy for severe eosinophilic asthma (SEA) in adults and adolescents aged 12 and above. This decision follows the positive outcomes of the MIRACLE Phase III clinical…
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Genmab’s Tepkinly/Epkinly Receives EC Nod for Relapsed Lymphoma Treatments
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COPENHAGEN—Genmab A/S (NASDAQ: GMAB), a leading biotech company, has announced that the European Commission (EC) has granted market approval for its Tepkinly/Epkinly (epcoritamab), a CD3/CD20 bispecific T cell engager. The drug is indicated for third-line or later treatment of relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large…
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Beijing Proposes New Regulations to Enhance Pharmaceutical Retail Standards and Services
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The Beijing Municipal Medical Products Administration has unveiled a draft proposal titled “Guiding Opinions on Further Strengthening the Standardized Management of Pharmaceutical Retail Enterprises and Improving the Quality of Pharmaceutical Services,” inviting public feedback until September 12, 2024. The proposal outlines several key initiatives aimed at enhancing the management and…
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AstraZeneca’s Imfinzi Gains FDA Approval for Neoadjuvant Use in Early-Stage Lung Cancer
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AstraZeneca (NASDAQ: AZN, LON: AZN) , the UK-based pharmaceutical powerhouse, has secured US FDA approval for a new indication of its PD-L1 inhibitor, Imfinzi (durvalumab). The FDA has authorized the use of Imfinzi in combination with chemotherapy for adults with resectable early-stage non-small cell lung cancer (NSCLC) classified as IIA-IIIB,…
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Sichuan Biokin Launches Phase III Trial for Bispecific ADC BL-B01D1 in Lung Cancer
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Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has commenced the first patient dosing in a Phase III clinical trial for its proprietary bispecific antibody drug conjugate (ADC), BL-B01D1. This innovative therapy is being evaluated for the treatment of recurrent small-cell lung cancer (SCLC) in patients who have previously not responded…
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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.…
