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Sichuan Biokin Gets NMPA Green Light for BL-B01D1 ADC in NSCLC Clinical Trial
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative antibody-drug conjugate (ADC), BL-B01D1. The approval allows for the combination of BL-B01D1 with a PD-1 inhibitor, with…
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Innovent Biologics’ Pemazyre Wins Macau Approval for Cholangiocarcinoma Treatment
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Innovent Biologics Inc. (HKG: 1801), a leading biopharmaceutical company in China, has received marketing approval from Macau for its cancer therapy Pemazyre (pemigatinib). The drug is indicated for patients with advanced, metastatic, or unresectable cholangiocarcinoma, who have been previously treated with at least one systemic therapy and have confirmed FGFR2…
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Kintor Pharmaceutical’s GT20029 Meets Primary Endpoint in Phase II AGA Trial
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Kintor Pharmaceutical Ltd (HKG: 9939), a clinical-stage biotechnology company, has announced that its Phase II clinical study for GT20029, a first-in-class proteolysis targeting chimera (PROTAC) compound, has met its primary endpoint in the treatment of male androgenetic alopecia (AGA) in China. The multi-center, randomized, double-blind, placebo-controlled study aimed to evaluate…
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GSK’s Shingrix Vaccine Maintains High Efficacy for Over a Decade, Phase III Data Show
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GlaxoSmithKline (GSK, LON: GSK, NYSE: GSK), the UK-based pharmaceutical giant, has this week released long-term data from a follow-up Phase III trial of its recombinant herpes zoster vaccine, Shingrix. The vaccine demonstrated robust efficacy in adults aged 50 and above, with a 79.7% efficacy rate sustained from year 6 to…
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AbbVie’s Rinvoq Meets Main Goal in Late-Stage Giant Cell Arteritis Trial
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AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has announced that a late-stage clinical trial for its JAK inhibitor Rinvoq (upadacitinib) in combination with corticosteroids has successfully met the primary endpoint in patients with giant cell arteritis (GCA). The study demonstrated sustained remission from week 12 through week 52. The…
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Chia Tai Tianqing’s Rovadicitinib Meets Main Goal in Myelofibrosis Trial, Eyes Market Filing
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Chia Tai Tianqing, a renowned pharmaceutical company based in China, has declared that it has successfully met the primary endpoint in a pivotal study for its Category 1 drug, rovadicitinib, for the treatment of medium-to-high-risk myelofibrosis (MF). The company is advancing towards filing for market approval in China, following consultations…
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Novartis’s Kesimpta Shows Sustained Efficacy in 6-Year Relapsing MS Study
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has this week unveiled six-year efficacy data for its anti-CD20 drug Kesimpta (ofatumumab) in the treatment of recently diagnosed relapsing multiple sclerosis (MS) in treatment-naive patients. The data shows that first-line continuous Kesimpta treatment, as compared to a teriflunomide regimen switched to Kesimpta, resulted…
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ImmuneOnco Receives NMPA Approval for Phase III Clinical Trial of CD47 Inhibitor TIMDARPACEPT
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its investigational drug timdarpacept (IMM01). This drug is the first SIRPαFc fusion protein targeting CD47 to be designed in China.…
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Shanghai Henlius Biotech Advances TIGIT-Targeting HLX53 to Phase II Clinical Trial for Hepatocellular Carcinoma
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Shanghai Henlius Biotech Inc., (HKG: 2696), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to commence a Phase II clinical study. The study will evaluate the tolerability, safety, and efficacy of HLX53, an Fc fusion protein targeting T cell immunoglobulin and ITIM…
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Amgen’s Tezspire Shows Promise in Phase IIa COPD Trial, Reduces Exacerbations
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Amgen (NASDAQ: AMGN), a multinational biopharmaceutical company, has this week announced results from a Phase IIa proof-of-concept trial for its anti-thymic stromal lymphopoietin (TSLP) biologic, Tezspire (tezepelumab), in patients with moderate-to-very-severe chronic obstructive pulmonary disease (COPD). The trial indicated that Tezspire reduced the annualized rate of moderate or severe exacerbations…
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Sichuan Biokin’s BL-B01D1 Earns Breakthrough Designation for Nasopharyngeal Carcinoma Treatment
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from the National Medical Products Administration for its antibody-drug conjugate (ADC), BL-B01D1. This designation is for the treatment of patients with late-stage locally advanced or metastatic nasopharyngeal…
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Innovent Biologics’ IBI133 Receives Tacit Approval for Clinical Trial from China’s CDE
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The Center for Drug Evaluation (CDE) in China has granted tacit clinical trial approval to Innovent Biologics, Inc. (HKG: 1801) for its antibody drug conjugate (ADC) IBI133. The molecule is slated for assessment as a treatment for irresectable locally advanced or metastatic solid tumors. Previously, in December 2023, IBI133 had…
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Shionogi’s Xofluza Gains Approval in Taiwan for Pediatric Influenza Treatment and Prophylaxis
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Shionogi & Co., Ltd, a leading Japanese pharmaceutical company, has announced that it has received approval for a supplemental new drug application (sNDA) in Taiwan for its influenza treatment and prophylaxis drug, Xofluza (baloxavir marboxil). This first-in-class, oral anti-viral medication is now approved for use in children aged between 5…
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Kangtai Biological Receives NMPA Approval for 20-Valent Pneumococcal Vaccine Clinical Trial
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Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601), a leading biopharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its 20-valent pneumococcal polysaccharide conjugate vaccine. The vaccine is designed to prevent infectious diseases caused by…
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KPC Pharmaceuticals Gets NMPA Green Light for Clinical Trial on Familial Mediterranean Fever Treatment
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Yunnan-based KPC Pharmaceuticals Inc., (SHA: 600422) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 2.2 product KPC-149, which is intended for the treatment of familial Mediterranean fever (FMF). FMF is an autosomal recessive autoimmune disease associated with mutations in…
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Carvykti CAR-T Therapy Sales Reach $157 Million in Q1 2024, Reports GenScript Subsidiary Legend Biotech
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GenScript Biotech Corporation (HKG: 1548), a leading Contract Research Organization (CRO) based in China, has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), achieved sales of USD 157 million for its BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), in the first quarter of 2024, which…
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China’s NMPA Releases 79th Batch of Reference Drugs for Generic Quality Evaluation
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The National Medical Products Administration (NMPA) in China has released the 79th batch of reference drugs for Generic Quality Consistency Evaluation (GQCE) work, marking a significant step in ensuring the quality and consistency of generic drugs in the country. This batch includes 64 new specifications and 34 modified specifications for…
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AstraZeneca’s Imfinzi Shows Sustained Survival Benefit in Advanced Biliary Tract Cancer Trial
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical and biopharmaceutical company, has this week announced 3-year results from a Phase III clinical trial of its anti-PD-L1 therapy Imfinzi (durvalumab) in combination with chemotherapy for the treatment of advanced biliary tract cancer (BTC). The trial, after a median follow-up of 41.3 months,…
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Sirnaomics Receives FDA Feedback on STP705 Development Plan for isSCC Treatment
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Sirnaomics Ltd (HKG: 2257), a leading biopharmaceutical company focused on the discovery and development of RNAi therapeutics, has announced receiving a written response from the U.S. Food and Drug Administration (FDA) regarding the required Class C meeting for STP705, a treatment for in situ squamous cell carcinoma (isSCC). The Class…
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China Medical System’s Opzelura Approved in Macau for Vitiligo Treatment
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China Medical System Holdings (CMS; HKG: 0867) has announced that it has received market approval in Macau for Opzelura (ruxolitinib) cream, a topical treatment indicated for patients aged 12 and above with non-segmental vitiligo involving the face. Opzelura, a topical Janus kinase (JAK) inhibitor, was initially approved in the U.S.…
