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J&J’s Tremfya Wins NMPA Approval for Crohn’s Disease Treatment
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Johnson & Johnson (J&J, NYSE: JNJ) announced that its Tremfya (guselkumab) has received marketing approval from China’s National Medical Products Administration (NMPA) for treating moderate to severe active Crohn’s disease (CD) in adults who have not responded adequately to traditional therapies or biologics. Drug ProfileTremfya, an interleukin-23 monoclonal antibody, was…
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Sanofi’s Sarclisa Wins New Japan Approval for Multiple Myeloma Combination Therapy
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Sanofi (EPA: SAN, NASDAQ: SNY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved a new indication for Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for adult patients with newly diagnosed multiple myeloma (NDMM). This marks the fourth treatment regimen approved for Sarclisa in…
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YolTech Therapeutics’ YOLT-203 Shows Promise in Primary Hyperoxaluria Type 1 Trial
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YolTech Therapeutics, a Shanghai-based startup specializing in lipid nanoparticle delivery and gene editing, announced positive results from an investigator-initiated trial (ITT) of YOLT-203 in patients with primary hyperoxaluria type 1 (PH1). The therapy marks the first in vivo gene-editing treatment to demonstrate positive clinical data for PH1, showing excellent safety…
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HQ Pharma and Shanghai Pharmaceuticals Expand Collaboration for Global Market Access
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China’s HQ Pharma (Shanghai) Co., Ltd has entered into a new collaboration agreement with Shanghai Pharmaceutical Import & Export Co., Ltd., a wholly owned subsidiary of Shanghai Pharmaceuticals (SPH, HKG: 2607, SHA: 601607). This partnership builds on their existing agreement from December 2023, aiming to enhance the international market access…
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Green Valley and Vazyme Team Up on Alzheimer’s Disease Initiatives
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China-based Green Valley (Shanghai) Pharmaceuticals Co., Ltd. and Vazyme Biotech Co., Ltd (SHA: 688105) have entered into a strategic partnership to collaborate on the screening, diagnosis, and early intervention of Alzheimer’s disease (AD). Collaboration GoalsThe partnership will leverage the strengths of both companies to: Strategic SynergiesBy combining their expertise, Green…
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Merck’s Keytruda sBLA for LA-HNSCC Accepted by FDA for Review
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Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced that the US Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) for review. The application seeks approval for Keytruda’s use in patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC)…
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CARsgen Therapeutics and Zhuhai SB Xinchuang Invest in UCARsgen for Allogeneic CAR-T Therapies
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has entered into an agreement with an investment fund managed by Zhuhai Hengqin SB Xinchuang Equity Investment Management Enterprise (Limited Partnership) to jointly invest in its subsidiary UCARsgen Biotech Limited. UCARsgen focuses on developing allogeneic CAR-T cell therapies for hematologic malignancies. Deal Highlights
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Eli Lilly Launches New Zepbound Doses with Lower Prices for Self-Pay Patients
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Eli Lilly & Co. (NYSE: LLY) announced the launch of 7.5 mg and 10 mg single-dose vials of Zepbound (tirzepatide) for self-pay patients with obesity, priced at USD 499 under the new Zepbound Self Pay Journey Program. Dosing OptionsThe program offers self-pay patients a range of Zepbound doses: 2.5 mg,…
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Suzhou Ribo Life Science’s RBD2080 siRNA Drug Receives Australian Clinical Trial Approval
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China-based Suzhou Ribo Life Science Co., Ltd announced that its siRNA drug RBD2080 has received clinical trial approval from Australia’s Therapeutic Goods Administration (TGA). The drug, designed to treat autoimmune diseases, will soon enter a Phase I study in Australia. Trial DetailsThe upcoming trial is a randomized, double-blind, placebo-controlled study…
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MicuRx Pharmaceuticals Sues Medpace Over Breach of Contract in Phase III Study
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Sino-US biotech firm MicuRx Pharmaceuticals Inc. (SHA: 688373) has filed a lawsuit against US-based Medpace, Inc. in the Western Division of the United States District Court for the Southern District of Ohio. The suit accuses Medpace of violating contractual obligations and seeks compensation for losses and expenses, including interest up…
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Eli Lilly Acquires Organovo’s FXR Program for Inflammatory Bowel Disease
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US-based Organovo Holdings, Inc. (NASDAQ: ONVO), a clinical-stage biotech focused on inflammatory bowel disease (IBD), announced that its FXR program, including lead asset FXR314, has been acquired by Eli Lilly and Company (NYSE: LLY). The transaction grants Lilly global commercial and intellectual property rights to the program. Transaction DetailsUnder the…
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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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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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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
