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Akeso Biopharma’s Penpulimab Approved for First-Line NPC Treatment
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China-based Akeso Biopharma (HKG: 9926) announced receiving another indication approval from the National Medical Products Administration (NMPA) for its PD-1 inhibitor penpulimab (AK105). The drug is now approved for use in combination with chemotherapy for first-line recurrent or metastatic nasopharyngeal carcinoma (NPC). Commercialization and Market PresencePenpulimab, a differentiated PD-1 therapy,…
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BioCity and MSD Enter Clinical Collaboration for BC3195 and Keytruda Combination Trial
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China-based BioCity Biopharmaceutics Co., Ltd. announced a clinical collaboration agreement with US-based giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK). The partnership will initiate a global Phase I/II study to evaluate the safety and efficacy of BioCity’s BC3195 in combination with MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) for patients with…
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CSPC Pharmaceutical Group Receives FDA Approval for SYH2051 Clinical Trial
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced receiving approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its in-house developed Category 1 chemical drug SYH2051. This ATM inhibitor will be assessed for use in general solid tumors, an indication previously approved for trials…
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Zai Lab Submits TIVDAK BLA to China’s NMPA for Cervical Cancer Treatment
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Zai Lab Limited (NASDAQ: ZLAB, HKG: 9688) announced that a Biological License Application (BLA) for TIVDAK (tisotumab vedotin-tftv), an antibody-drug conjugate (ADC) originated by Seagen Inc., has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step forward in making this innovative therapy available…
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MindRank Ltd Receives FDA Clearance for MRANK-106 Clinical Study in Solid Tumors
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China-based artificial intelligence (AI)-enabled drug developer MindRank Ltd announced receiving clearance from the US Food and Drug Administration (FDA) to initiate a clinical study for its MRANK-106, a dual inhibitor of WEE1 and YES1 kinases. This marks a significant milestone for the company as it expands its innovative oncology pipeline…
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AstraZeneca’s Imfinzi Approved by NMPA for Early-Stage NSCLC Treatment
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UK-based giant AstraZeneca (NASDAQ: AZN) received approval from China’s National Medical Products Administration (NMPA) for a new indication for its PD-L1 inhibitor Imfinzi (durvalumab). The approval allows Imfinzi to be used in combination with chemotherapy for adults with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC), specifically for patients without…
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Genmab’s HexaBody-CD38 Clinical Development Halted After J&J Opt-Out
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Denmark-based Genmab A/S (NASDAQ: GMAB) announced that US giant Johnson & Johnson (J&J, NYSE: JNJ) has decided not to exercise its option to obtain a worldwide license for the development, manufacturing, and commercialization of HexaBody-CD38 (GEN3014). Consequently, clinical development of the drug will be terminated. The decision was based on…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for SHR-4602 Clinical Study in Advanced Solid Tumors
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) announced receiving approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its SHR-4602 in combination with SHR-A2102, with or without adebrelimab (SHR-1316), in advanced solid tumors. This marks a significant step forward in the development of innovative…
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Jiangsu Cowin Biotech Obtains NMPA License for Gene Methylation Detection Kit
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China-based Jiangsu Cowin Biotech Co., Ltd. (SHA: 688426) announced receiving a Category III medical device license from the National Medical Products Administration (NMPA) for its human Septin9, SDC2, and NDRG4 gene methylation detection kit (fluorescence PCR method). This approval marks a significant step forward in the company’s efforts to provide…
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Pfizer’s Elrexfio Receives Conditional NMPA Approval for Relapsed Multiple Myeloma
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US giant Pfizer (NYSE: PFE) announced receiving conditional approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb) Elrexfio (elranatamab). The drug is now approved to treat triple-class exposed (TCE) relapsed or refractory multiple myeloma (r/r MM). Mechanism of ActionElrexfio works by binding to CD3 on T…
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TYK Medicines Inc.’s TY-9591 Shows Superiority Over Osimertinib in EGFR Mutated Lung Cancer with Brain Metastasis
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Zhejiang-based TYK Medicines Inc. (HKG: 2410) announced positive results from a pivotal Phase II study positioning TY-9591 against osimertinib as a first-line treatment for epidermal growth factor receptor (EGFR) mutated lung cancer with brain metastasis. The data demonstrated statistical significance and significant clinical benefits, marking a potential breakthrough in the…
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Fosun Pharmaceutical’s Foritinib Accepted for Review by China’s NMPA for NSCLC Treatment
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) announced that the National Medical Products Administration(NMPA) has accepted for review a market filing for its subsidiary Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.’s Category 1 chemical drug foritinib. This novel small molecule chemical drug is designed to treat…
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Abbisko Therapeutics’ ABSK131 Receives Clinical Trial Approval from China’s NMPA
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving clinical trial approval from the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) for its small molecule inhibitor ABSK131. This follows a similar approval from US regulators in December of last year. ABSK131: Promising Anti-Tumor ActivityABSK131…
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Cryofocus Medtech’s Malignant Stenosis Cryoablation System Approved by NMPA for Chinese Market
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Shanghai-based cryoablation treatment specialist Cryofocus Medtech (Shanghai) Co., Ltd (HKG: 6922) has announced receiving endorsement from the National Medical Products Administration (NMPA) to market its malignant stenosis cryoablation system in China. This innovative technology represents a significant advancement in the treatment of malignant airway tumors. Innovative Cryoablation TechnologyThe malignant stenosis…
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BioRay Biopharmaceutical’s BR111 Receives NMPA Clearance for Clinical Trials in ROR1-Positive Malignancies
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Zhejiang-based BioRay Biopharmaceutical has announced receiving clearance from the National Medical Products Administration (NMPA) to initiate clinical trials for its Category 1 biologic product, BR111. The drug, an antibody-drug conjugate (ADC) targeting dual epitopes of ROR1, is being developed to treat ROR1-positive hematological malignancies and solid tumors, marking a significant…
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Antengene’s Xpovio Receives Marketing Approval in Indonesia
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced receiving marketing approval in Indonesia for its Xpovio (selinexor). The approval grants the drug three indications in the Southeast Asian country. Indications ApprovedThe drug is approved for: Drug BackgroundXpovio, the world’s first and only FDA-approved oral XPO1 inhibitor, was discovered by US-based…
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Yifan Pharma Secures Rights to Bayer’s Stivarga and Nexavar in China
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China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) announced a commercialization agreement with Bayer (ETR: BAYN), securing exclusive rights to promote the German company’s Stivarga (regorafenib) and Nexavar (sorafenib) in mainland China. Yifan Pharma’s PortfolioYifan Pharma has a team of 300 specialists in oncology marketing and sales. Its product lineup includes…
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RongCan Biotech’s mRNA HPV Vaccine Receives FDA Clinical Approval
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China-based mRNA specialist RongCan (Shanghai) Biotech Co., Ltd announced that it has received clinical approval from the US Food and Drug Administration (FDA) for its mRNA-based human papillomavirus (HPV) therapeutic vaccine. Clinical Approval and SignificanceThis approval marks a significant step forward in the development of therapeutic options for HPV-related conditions.…
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Baheal Pharmaceutical Gains Exclusive Rights to Roche’s MabThera in China
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China-based health services and distribution giant Baheal Pharmaceutical Group (SHE: 301015) last month reached an accord with Roche (SWX: ROG, OTCMKTS: RHHBY), securing exclusive market promotion rights to the Swiss giant’s MabThera (rituximab) in mainland China. Drug ProfileMabThera, the world’s first anti-CD20 monoclonal antibody (mAb), is used to treat Hodgkin…
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CStone Pharmaceuticals and SteinCares Ink Licensing Deal for PD-L1 Inhibitor in Latin America
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China-based CStone Pharmaceuticals (HKG: 2616) and Costa Rica-based drug maker and distributor SteinCares have entered into a licensing agreement. Under the terms of the agreement, SteinCares will obtain exclusive commercialization rights to CStone’s anti-programmed death-ligand 1 (PD-L1) inhibitor sugemalimab (trade name: Cejemly) in the Latin American market, including Brazil, Argentina,…
