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China’s Henlius Biotech Partners with Sermonix for Japan Development of Breast Cancer Drug
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Shanghai Henlius Biotech Inc. (HKG: 2696), a prominent biopharmaceutical company based in China, has announced an expansion of its licensing agreement with Sermonix Pharmaceuticals Inc., to include additional territories in Asia for the development and commercialization of HLX78 (oral lasofoxifene). This supplementary agreement facilitates a co-development partnership between Henlius and…
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Healthcare Firms Line Up for HKEX IPOs as Biotech Market Recovery Gains Momentum
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A number of healthcare companies are seeking to capitalize on the recovering market conditions by filing for initial public offerings (IPOs) on the Hong Kong Stock Exchange (HKEX), a venue that has been gaining traction among life sciences companies for their public listings. According to the HKEX website, recent IPO…
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Hinova Pharmaceuticals’ HP518 Earns FDA Fast-Track Designation for AR+ Triple Negative Breast Cancer
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Hinova Pharmaceuticals (SHA: 688302), a biopharmaceutical company based in China, has announced that it has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its drug candidate HP518 for the treatment of androgen receptor (AR)-positive triple negative breast cancer (TNBC). The Category 1 innovative drug candidate, HP518,…
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Gloria Bio’s Motixafortide Approved as Urgently Needed Import Drug by Hainan Medical Products Administration
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Guangzhou Gloria Biosciences Co., Ltd, a biopharmaceutical company based in China, has received approval from the Hainan Medical Products Administration for its CXCR4 antagonist motixafortide (BL-8040) as a special drug for import due to clinical urgency. The drug will be implemented and administered by Hainan Boao Lu Medical Hospital, a…
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BeiGene’s Tislelizumab Approved by China’s NMPA for First-Line Extensive Stage Small Cell Lung Cancer
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235), a biopharmaceutical company, has announced that its programmed-death (PD)-1 monoclonal antibody (mAb), tislelizumab, has received approval from the National Medical Products Administration (NMPA) in China. The drug is now approved to be used in combination with chemotherapy for the treatment of patients with…
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Grand Pharmaceutical Group Ltd’s SIR-Spheres Set to Reach Wider Patient Base Through MediTrust Health Deal
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Grand Pharmaceutical Group Ltd (HKG: 0512), a leading pharmaceutical company based in China, has announced a strategic partnership with MediTrust Health, an insurance, financing, and direct-to-patient pharmacy subsidiary of Shanghai Pharmaceuticals Holding Co., Ltd. This collaboration will focus on integrating Grand Pharma’s 90Y product into various commercial insurance schemes, aiming…
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IASO Biotherapeutics’ RD118 CAR-T Therapy Receives Clinical Trial Approval for Multiple Myeloma
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IASO Biotherapeutics, a biopharmaceutical company based in China, has announced that it has received tacit clinical trial approval from the National Medical Products Administration (NMPA) for its investigational therapy, RD118. RD118 is a fully human GPRC5D-targeted chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of relapsed/refractory multiple myeloma (r/r…
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CSPC Pharmaceutical’s Enronsubaimab Gets NMPA Nod for Recurrent Cervical Cancer
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) of China has approved its market approval filing for enronsubaimab, a programmed-death 1 (PD-1) monoclonal antibody (mAb). The drug is indicated for the treatment of recurrent or metastatic…
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Genmab and AbbVie’s Epcoritamab Earns FDA Accelerated Approval for Follicular Lymphoma
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Genmab A/S (NASDAQ: GMAB), a Danish biotechnology company, and its co-development partner AbbVie (NYSE: ABBV), have announced that the U.S. Food and Drug Administration (FDA) has granted the first approval for Tepkinly/Epkinly (epcoritamab), an off-the-shelf T-cell engaging CD3xCD20-targeted bispecific antibody (BsAb). The molecule has received accelerated approval for the treatment…
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Novo Nordisk Moves to Acquire 2seventy bio’s Hemophilia A Program and Gene-Editing Technology
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Novo Nordisk (NYSE: NVO; CPH: NOVO-B), a leading Danish biopharmaceutical company, is transitioning from a partnership to an acquisition deal with U.S. biotech firm 2seventy bio Inc. (NASDAQ: TSVT) for the development of a hemophilia A drug candidate. The companies have entered into an asset purchase agreement that will see…
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Abbisko Therapeutics Presents Positive Phase II Results for HCC Treatment at ESMO-GI
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotech company, has announced the presentation of Phase II study results for its irpagratinib in combination with atezolizumab for the treatment of advanced hepatocellular carcinoma (HCC) at the 2024 ESMO-GI annual meeting. Irpagratinib, a novel FGFR4 inhibitor discovered and developed by Abbisko,…
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Dizal Pharmaceutical’s Golidocitinib Breaks Record with Rapid Market Launch in China
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has seen its drug golidocitinib go from marketing approval to first prescriptions in a record time of just two days in China. This marks a significant milestone, as golidocitinib is the first and only approved Janus kinase 1…
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Amoy Diagnostics Partners with Servier to Develop Companion Diagnostic Reagent for IDH Mutations in China
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China-based Amoy Diagnostics Co., Ltd (AmoyDx, SHE: 300685) has entered into a partnership with French pharmaceutical company Servier to co-develop a companion diagnostic (CDx) reagent in China. This reagent is designed for detecting mutations in the isocitrate dehydrogenase (IDH) 1 and 2 genes. The product will complement Servier’s vorasidenib, which…
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Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Nod for First-Line TNBC Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced that it has received an additional indication approval from China’s National Medical Products Administration (NMPA) for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab). The drug can now be used in combination with Paclitaxel (Albumin bound) for the first-line treatment…
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Antengene’s Xpovio Included in South Korea’s NHIS Reimbursement Drug List
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that South Korea’s National Health Insurance Service (NHIS) has included its drug Xpovio (selinexor) in the medical insurance reimbursement drug list, effective from July 1, 2024. The drug is indicated for the treatment of adult patients with…
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Novartis’s Scemblix STAMP Inhibitor for CML Accepted for Review by China’s NMPA
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Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has had its market filing for Scemblix (asciminib) accepted for review by China’s National Medical Products Administration (NMPA). Scemblix is a Specifically Targeting the ABL Myristoyl Pocket (STAMP) inhibitor, which is filed for the treatment of chronic myeloid leukemia (CML). As the world’s…
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Merck’s HER3-Targeted ADC Patritumab Deruxtecan Faces FDA Complete Response Letter
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Merck, Sharp & Dohme Inc. (NYSE: MRK), a leading U.S. pharmaceutical company, has announced that it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for patritumab deruxtecan, a first-in-class HER3-targeted antibody-drug conjugate (ADC) discovered by Daiichi Sankyo…
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AstraZeneca’s Tagrisso Wins NMPA Approval for First-Line EGFR-mutated NSCLC Treatment
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its drug Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI). The drug is now approved for use in combination with chemotherapy as a first-line treatment for…
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CSPC Pharmaceutical’s BCMA-Targeted CAR-T Therapy SYS6020 Receives NMPA Clinical Trial Approval
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for SYS6020, a BCMA-targeted chimeric antigen receptor (CAR)-T cell therapy. This marks a significant milestone for the company as SYS6020 is…
