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Astellas Pharma’s Xospata Wins Regular NMPA Approval for FLT3-Mutated AML
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Japan-based Astellas Pharma Inc. (TYO: 4503, OTCMKTS: ALPMY ) announced that the National Medical Products Administration (NMPA) has converted the conditional approval for its Xospata (gilteritinib) into regular approval. The decision is based on data from the COMMODORE study, a Phase III trial comparing gilteritinib to salvage chemotherapy in patients…
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Sunshine Guojian and Shenyang 3SBio License 612 and 708 Programs for Anti-Tumor Development
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China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd and Shenyang 3SBio Co., Ltd, both subsidiaries of 3SBio Inc. (HKG:1530), have entered into a licensing agreement for Sunshine Guojian’s 612 and 708 programs. Under the agreement, Shenyang 3SBio will obtain exclusive rights to develop, file regulatory applications, modify, use, manufacture, and market…
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CSPC Pharma Licenses SYS 6005 to Radiance Biopharma for Global Markets
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) announced a licensing agreement with Radiance Biopharma, Inc., granting the US firm exclusive development and commercialization rights to its SYS 6005 in multiple countries, including the United States, European Union, United Kingdom, Switzerland, Australia, and Canada. Deal TermsUnder the agreement, CSPC Pharma will…
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InnoCare Pharma Receives NMPA Approval for Mesutoclax Phase III Study in CLL/SLL
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Beijing-based biotech InnoCare Pharma (HKG: 9969, SHA: 688428) announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a regulatory Phase III clinical study for its B-cell lymphoma-2 (BCL2) inhibitor mesutoclax (ICP-248) in combination with its Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib. The study will…
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Zelgen Biopharmaceuticals’ ZG005 Bispecific Antibody Receives NMPA Approval for Biliary Tract Cancer Trials
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its pipeline candidate ZG005. The Category 1 biologic product will be tested in combination with a platinum-containing chemotherapy regimen for advanced biliary tract cancer. Drug ProfileZG005…
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3SBio and Sichuan Biokin Partner to Advance Solid Tumor Treatment in China
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China-based 3SBio Inc. (HKG: 1530) has announced a strategic partnership with fellow domestic firm Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506). The collaboration aims to advance the exploration of combining 3SBio’s 707 and Sichuan Biokin’s BL-B01D1 for the treatment of solid tumors in mainland China. Drug Profiles Collaboration DetailsThe partnership…
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IASO Bio’s Fucaso NDA Accepted by Hong Kong DOH for Relapsed/Refractory Multiple Myeloma
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China-based IASO Bio announced that a New Drug Application (NDA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy Fucaso (equecabtagene autoleucel) has been accepted for review by the Hong Kong Department of Health (DOH). The application is for the treatment of relapsed/refractory multiple myeloma (R/R MM) in patients…
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Innovent Biologics’ IBI363 Receives FDA Fast-Track Designation for sqNSCLC
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China-based Innovent Biologics, Inc. (HKG: 1801) announced that it has received another fast-track designation from the US Food and Drug Administration (FDA) for its IBI363. The PD-1/IL-2α bispecific antibody fusion protein, previously granted fast-track status for melanoma, has now been awarded the designation for the treatment of unresectable, locally advanced,…
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Konruns Pharmaceutical’s KC1036 Enters Phase II Trial for Ewing’s Sarcoma in Adolescents
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) announced the first patient dosing in a Phase II clinical study of its KC1036 for adolescents aged 12 and above with advanced Ewing’s sarcoma (ES). Drug DetailsKC1036 is a Category 1.1 chemical drug and a tyrosine kinase inhibitor (TKI) targeting AXL, VEGFR2, and…
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New Guidelines for Advanced Gastric Cancer Drug Development Released in China
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The National Medical Products Administration (NMPA) of China has published the “Guidance Principles for Clinical Trial Design of New Drugs for Advanced Gastric Cancer,” offering a comprehensive framework to optimize drug development and accelerate patient access to innovative treatments. Key Components of the Guidance 1. Molecular Profiling and BiomarkersThe document…
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Bristol Myers Squibb’s Opdualag Fails to Meet Primary Endpoint in Melanoma Study
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US pharmaceutical major Bristol-Myers Squibb (BMS, NYSE: BMY) provided an update on the RELATIVITY-098 study for its Opdualag (nivolumab and relatlimab-rmbw). The Phase III study, which evaluated the drug as an adjuvant treatment for patients with completely resected stage III-IV melanoma, failed to meet its primary endpoint of recurrence-free survival…
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Betta Pharma Files for EMA Approval of ALK Inhibitor Ensartinib
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Betta Pharmaceuticals (SHE: 300558) announced the initiation of a market approval filing with the European Medicines Agency (EMA) for its anaplastic lymphoma kinase (ALK) inhibitor, ensartinib. The drug is under co-development with Betta affiliate Xcovery. The Chinese firm is seeking EMA approval for the drug’s use as a first-line treatment…
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Antengene’s Xpovio Included in Taiwan’s NHI Drug List for Myeloma Treatment
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China-based biopharma Antengene Corp., Ltd (HKG: 6996) announced that its Xpovio (selinexor), the world’s first FDA-approved oral XPO1 inhibitor, has been included in Taiwan’s National Health Insurance (NHI) drug list. The approved indication is for use in combination with bortezomib and dexamethasone in adults previously treated with one therapy for…
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OnCusp Therapeutics’ CUSP06 Receives FDA Fast Track for Ovarian Cancer
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Sino-US company OnCusp Therapeutics Inc. has announced that it has received Fast Track Designation (FTD) from the US Food and Drug Administration (FDA) for its CUSP06. CUSP06 is a Cadherin-6 targeting antibody-drug conjugate (CDH6 ADC). The targeted indication for this therapy is platinum-resistant ovarian cancer (PROC). Drug DetailsCUSP06, the CDH6…
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AbbVie Collaborates with Xilio Therapeutics on Tumor-Activated Immunotherapies
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US pharmaceutical giant AbbVie (NYSE: ABBV) has announced a collaboration and option-to-license agreement with fellow US firm Xilio Therapeutics, Inc. (NASDAQ: XLO). The partnership aims to leverage Xilio’s proprietary technology to develop novel tumor-activated, antibody-based immunotherapies, including masked T-cell engagers. Details of the CollaborationXilio, with its proprietary, clinically-validated platform technology…
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Bristol-Myers Squibb’s Breyanzi Hits Primary Endpoint in Lymphoma Study
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Bristol-Myers Squibb (BMS, NYSE: BMY) reported positive results from the Phase II TRANSCEND FL study of Breyanzi (lisocabtagene maraleucel), its CD19-directed CAR T cell therapy, in adults with relapsed or refractory indolent B-cell non-Hodgkin lymphoma (NHL). The trial met its primary endpoint in the marginal zone lymphoma (MZL) cohort, demonstrating…
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CARsgen’s Allogeneic BCMA CAR-T Therapy Achieves sCR in First Patient
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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) announced that the first patient treated with its allogeneic BCMA chimeric antigen receptor (CAR)-T therapy, developed on the THANK-u Plus platform, achieved a stringent complete response (sCR) and minimal residual disease (MRD) negativity at the Day-28 assessment. Patient Background and TreatmentThe patient, diagnosed…
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Biokin Pharmaceutical’s BL-M07D1 Gains NMPA Approval for Phase III Study
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China-based Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III clinical study for its BL-M07D1. The randomized, controlled trial will assess BL-M07D1 versus trastuzumab emtansine as a postoperative adjuvant treatment for HER2-positive breast cancer…
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Henlius Biotech Licenses HLX15 to Dr. Reddy’s for US and European Markets
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) announced a licensing deal with India-headquartered Dr. Reddy’s Laboratories Ltd. (BOM: 500124) for its HLX15, a biosimilar version of Johnson & Johnson’s Darzalex (daratumumab). Under the agreement, Dr. Reddy’s will obtain exclusive commercialization rights to the anti-CD38 monoclonal antibody (mAb), including both intravenous…
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Chipscreen Biosciences Gains NMPA Approval for Epidaza Phase III Study
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China-based Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase III study assessing its Epidaza (chidamide) combined with CHOP in naive, peripheral T-cell lymphoma with T-follicular helper phenotype (PTCL-TFH). This approval marks a significant step…
