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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,…
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BeiGene’s Tevimbra Receives FDA Approval for ESCC Treatment
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BeiGene, Ltd. (NASDAQ: ONC, HKG: 6160, SHA: 688235), a multinational oncology company planning to change its name to BeOne Medicines Ltd, announced that it has received another indication approval from the US Food and Drug Administration (FDA) for its Tevimbra (tislelizumab). The PD – 1 inhibitor is now approved for…
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AstraZeneca and Daiichi Sankyo’s Enhertu Shows Positive Results in Phase III Study
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Partners AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) announced positive topline results from the Phase III DESTINY-Gastric04 study for Enhertu (trastuzumab deruxtecan). The HER2-targeted antibody drug conjugate (ADC) has demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of overall survival (OS) in patients with second-line…
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Fapon Biopharma’s FP008 Receives FDA Approval for Clinical Trials
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China-based Fapon Biopharma announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its FP008, an anti-PD-1 × IL-10M fusion protein designed to target solid tumors refractory to anti-PD-1 therapy. Drug ProfileFP008 is a first-in-class immunocytokine with a unique mechanism of action (MOA).…
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Zai Lab’s Augtyro Receives TFDA Approval for ROS1-Positive NSCLC and NTRK Fusion Solid Tumors
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) announced that it has received marketing approval from the Taiwan Food and Drug Administration (TFDA) for its Augtyro (repotrectinib). The drug is approved for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC) and adult…
