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Acotec Scientific’s Vericor Catheter Wins NMPA Approval for Peripheral Vascular Surgery
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) announced that its peripheral disposable support catheter Vericor has received marketing approval from the National Medical Products Administration (NMPA). The device is designed for peripheral vascular surgery, aiding in lesion access and treatment. Product ProfileSupport catheters are essential tools in peripheral vascular procedures,…
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CANbridge Pharmaceuticals Doses First Patient in CAN108 Biliary Atresia Study
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China-based rare disease specialist CANbridge Pharmaceuticals Inc. (HKG: 1228) announced that the first patient has been dosed in the Phase II EMBARK study of CAN108 (maralixibat) for biliary atresia (BA). The global, multi-center, randomized, controlled trial aims to enroll 72 patients, including 20 in China, to evaluate the drug’s efficacy…
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Sandoz Launches Pyzchiva Biosimilar of J&J’s Stelara in US
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Switzerland-based Sandoz (SWX: SDZ) announced the launch of Pyzchiva, a biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) autoimmune drug Stelara (ustekinumab), in the US. The drug, developed by South Korea’s Samsung Bioepis Co., Ltd., is approved for the same chronic inflammatory disease indications as the originator. Licensing DealSandoz…
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CDE Includes Chiral Tech’s Cerdelga Generic in Rare Disease Care Plan
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China’s Center for Drug Evaluation (CDE) announced the inclusion of Beijing Chiral Tech’s generic version of Sanofi Genzyme’s Cerdelga (eliglustat) in the patient-centered rare disease drug development pilot program, known as the Care Plan. The move aims to accelerate access to affordable treatments for rare diseases. Drug ProfileEliglustat, a glucosylceramide…
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Medtronic’s BrainSense Adaptive DBS Wins FDA Approval for Parkinson’s Treatment
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US-Irish medical device giant Medtronic (NYSE: MDT) announced that the US Food and Drug Administration (FDA) has approved its BrainSense Adaptive deep brain stimulation (aDBS) system and BrainSense Electrode Identifier (EI) for treating Parkinson’s disease (PD). The approval marks a milestone in personalized neurological therapies. Technology HighlightsThe BrainSense system uses…
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SMPA Suspends Indobufen Procurement After Patent Infringement Verdict
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Shanghai’s Sunshine Medical Procurement All-In-One (SMPA) announced the suspension of procurement for indobufen, manufactured by Hunan Jiudian Pharmaceutical and Zhejiang Tongwu Biomedical, following a patent infringement verdict by the Hangzhou Intellectual Property Office. The decision highlights ongoing disputes over the drug’s patent status in China. BackgroundIndobufen, an isoindolylphenylbutyric acid derivative…
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Xellsmart’s iPSC Therapy XS-228 Receives FDA Approval for ALS Study
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Suzhou-based stem-cell startup Xellsmart announced that the U.S. FDA has approved its regulatory study of XS-228, an iPSC-derived neural precursor cell therapy, for amyotrophic lateral sclerosis (ALS). The therapy, designed to provide a universal cell treatment for ALS patients, received orphan drug designation (ODD) from the FDA in December 2023.…
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Huadong Medicine’s HDM1005 Receives NMPA Approval for OSA Treatment
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China-based Huadong Medicine Co., Ltd (SHE: 000963) announced that its HDM1005, a long-acting GLP-1/GIP receptor agonist, has received clinical trial approval from the National Medical Products Administration (NMPA) for obstructive sleep apnea (OSA) combined with obesity or overweight. The drug previously received nods for type 2 diabetes, weight loss, and…
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Pfizer’s Hympavzi (Marstacimab) Launched in China’s Boao Lecheng Pilot Zone for Hemophilia
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Pfizer Inc. (NYSE: PFE) announced the implementation of its hemophilia therapy Hympavzi (marstacimab) in China’s Boao Lecheng Medical Tourism Pilot Zone. The drug, approved in the U.S. and European Union, is the first innovative therapy to be administered subcutaneously once weekly via a pre-filled injection pen for hemophilia A and…
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Summit Therapeutics and Pfizer Collaborate on Ivonescimab-ADC Combo for Solid Tumors
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Summit Therapeutics Inc. (NASDAQ: SMMT), the U.S. partner of China-based Akeso Inc. (HKG: 9926) for ivonescimab, announced a clinical collaboration with Pfizer (NYSE: PFE) to evaluate the combination of ivonescimab, Akeso’s PD-1/VEGF bispecific antibody (BsAb), with Pfizer’s antibody drug conjugates (ADCs) in multiple solid tumors. Collaboration DetailsUnder the agreement, Summit…
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Dizal Pharma’s 2024 Revenues Surge 295% to RMB360M, Loss Narrows by RMB251M
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) released its 2024 financial preview, showing annual revenues jumped 294.79% year-on-year (YOY) to RMB360.4 million ($49.67 million). Net loss attributable to the parent company was RMB856.77 million ($118 million), down RMB250.94 million ($34.6 million) from 2023. Key Highlights
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Bristol-Myers Squibb’s Opdivo-Yervoy Combo Nears FDA Approval for MSI-H Colorectal Cancer
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Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the U.S. FDA has accepted its filing for Opdivo (nivolumab) combined with Yervoy (ipilimumab) as a first-line treatment for adult and pediatric patients (aged 12+) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC). The FDA set…
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CanSino Biologics Receives NMPA Approval for DTcP Hib MCV4 Combined Vaccine
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China-based vaccine specialist CanSino Biologics Inc. (HKG: 6185) announced that its absorbed diphtheria, tetanus, acellular pertussis (DTcP), Haemophilus influenzae type b (Hib), and Group ACYW135 meningococcal (MCV4) combined vaccine has received clinical trial approval from the National Medical Products Administration (NMPA). The single-dose vaccine aims to provide comprehensive immune protection…
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MGI Tech Partners with Oncoclínicas&Co to Advance Precision Medicine in Brazil
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China-based gene sequencing specialist MGI Tech Co., Ltd (SHA: 688114) has partnered with OC Medicina de Precisão of Oncoclínicas&Co, Latin America’s largest cancer treatment group. The collaboration aims to promote precision medicine innovation in Brazil, offering efficient and personalized cancer diagnosis and treatment. Partnership DetailsThe partnership combines OC Medicina de…
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Boehringer Ingelheim’s Nerandomilast Receives NMPA Review for IPF Treatment
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Boehringer Ingelheim announced that its investigational drug nerandomilast has been accepted for review by the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA). The German pharma giant seeks approval for the oral phosphodiesterase 4B (PDE4B) inhibitor to treat idiopathic pulmonary fibrosis (IPF) in adults. Clinical Trial…
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QYuns Therapeutics’ QX002N Meets Primary Endpoint in AS Phase III Study
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China-based Jiangsu QYuns Therapeutics Co., Ltd (HKG: 2509) announced that its Phase III study of QX002N, an anti-IL-17A monoclonal antibody, in ankylosing spondylitis (AS) has met its primary endpoint. The multi-center, randomized, double-blinded, placebo-controlled trial enrolled 641 patients with moderate to severe AS. Study Results
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Takeda’s Takhzyro Receives EMA Approval for New Administration Form in HAE Patients
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Japan-headquartered Takeda (NYSE: TAK, TYO: 4502) announced that the European Medicines Agency (EMA) has approved a label extension for Takhzyro (lanadelumab) for subcutaneous administration in adolescents aged 12 and above and adult patients with Hereditary Angioedema (HAE) using a 2 mL pre-filled pen. Drug ProfileTakhzyro is now approved in the…
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National Allied Procurement Office Allows VBP Winners to Adjust MAH and Manufacturing Details
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The National Allied Procurement Office has issued a notification clarifying rules for China’s Volume-Based Procurement (VBP) tender program, allowing winning manufacturers to modify key details such as the marketing authorization holder (MAH), manufacturing company, packaging specs, and supply arrangements under specific conditions. The changes aim to maintain supply stability while…
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Ipsen Posts 8.7% Revenue Growth in 2024, Driven by Rare Diseases and Oncology
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French biopharma firm Ipsen (EPA: IPN, OTCMKTS: IPSEY) reported an 8.7% year-on-year (YOY) increase in global revenues to €3.4 billion ($3.57 billion) for 2024, according to its annual financial report. Core operating profit rose 10.8% YOY to €1.109 billion ($1.165 billion), driven by strong performances across all business sectors. Sector…
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Meyer FSMP Hong Kong Secures NMPA Approval for First FSMP in Greater China
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Hong Kong-based Meyer FSMP Hong Kong Limited, an oncology-focused foods for special medical purpose (FSMP) company, announced it has received marketing approval from China’s National Medical Products Administration (NMPA) for its carbohydrate component formula. The product is the first FSMP approved in the Hong Kong, Macao, and Taiwan regions. Product…
