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InventisBio’s KRAS G12C Inhibitor Garsorasib NDA Accepted for Review by China’s NMPA
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InventisBio (Shanghai) Co., Ltd (SHA: 688382), a China-based pharmaceutical company, has announced that the New Drug Application (NDA) for its candidate garsorasib (D-1553) has been accepted for review by China’s National Medical Products Administration (NMPA). The KRAS G12C inhibitor is intended for the treatment of locally advanced or metastatic non-small…
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Shanghai Junshi Biosciences’ Toripalimab Gains NMPA Approval for NSCLC Perioperative Treatment
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180), a leading biopharmaceutical company based in China, has announced an additional indication approval for its programmed death-1 (PD-1) inhibitor, Loqtorzi (toripalimab), from China’s National Medical Products Administration (NMPA). The drug is now approved for use as perioperative treatment in combination with…
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Roche’s Phesgo and Faricimab Receive NMPA Approvals for Breast Cancer and nAM
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The National Medical Products Administration (NMPA) has granted separate approvals for two distinct drugs from Swiss pharmaceutical giant Roche (SWX: ROG). The first approval is for Phesgo (trastuzumab, pertuzumab), indicated for the treatment of HER2-positive early and metastatic breast cancer. The second approval is for faricimab, which targets neovascular age-related…
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BeiGene’s Tislelizumab Secures 12th Indication Approval in China for HCC First-Line Treatment
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BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has received approval in China for the first-line treatment of irresectable or metastatic hepatocellular carcinoma (HCC), marking the drug’s 12th indication approval in the country. The approval is supported by the RATIONALE 301 study, a randomized, open-label, global…
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BMS’ Augtyro Receives EMA Review for Advanced Lung Cancer and Solid Tumors Treatments
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The European Medicines Agency (EMA) has accepted for review a filing submitted by Bristol Myers Squibb (BMS; NYSE: BMY) for its orphan drug, Augtyro (repotrectinib), which targets ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and NTRK-positive locally advanced or metastatic solid tumors. The next-generation tyrosine kinase inhibitor…
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Allorion Therapeutics Strikes Deal with AstraZeneca for EGFR L858R Inhibitor Development and Commercialization
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Allorion Therapeutics, a China-based biopharmaceutical company, has announced an exclusive option and global licensing agreement with AstraZeneca (AZ, NASDAQ: AZN) to develop and commercialize a novel allosteric inhibitor targeting the L858R mutation of the epidermal growth factor receptor (EGFR). The drug is intended for the treatment of advanced EGFR mutant…
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Hainan Poly Pharm’s Novel Nanomedicine PLAT001 Gets US FDA Approval for Clinical Trials
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its novel injectable PLAT001, intended for the treatment of advanced or metastatic solid tumors, including pancreatic cancer. PLAT001, a groundbreaking nanomedicine,…
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Medilink Therapeutics Secures Multi-Billion Dollar Deal with Roche for c-MET Targeting ADC
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Medilink Therapeutics, a Suzhou-based biopharmaceutical company, has entered into a global collaboration and licensing agreement with Swiss pharmaceutical giant Roche concerning YL211, an antibody drug conjugate (ADC) targeting c-Mesenchymal-epithelial transition factor (c-MET) for the development of a treatment for solid tumors. This agreement marks Medilink’s fifth out-license deal for ADC…
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Beijing Avistone Pharmaceuticals Raises RMB 1 Billion in Series B Funding to Accelerate Drug Development
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Beijing Avistone Pharmaceuticals Biotechnology Co., Ltd, based in China, has successfully closed its Series B funding round, raising RMB 1 billion (approximately USD 140 million). The round was jointly led by CS Capital and IDG Capital, with additional contributions from YanChuang Group, Cathay Capital, and existing investor Bain Capital. The…
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Boan Biotech Secures FDA Orphan Drug Designations for Pancreatic Cancer Treatments
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China-based Boan Biotech (HKG: 6955) has announced that its novel antibody BA1105 and antibody-drug conjugate (ADC) BA1301 have received orphan drug designations (ODDs) from the U.S. Food and Drug Administration (FDA). Both therapies target Claudin18.2 (CLDN18.2) for the treatment of pancreatic cancer. BA1105 is being developed for Claudin18.2 positive advanced…
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Gilead’s Kite Receives FDA Nod to Add Overall Survival Data to Yescarta for Large B-Cell Lymphoma
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Gilead Sciences Inc. (NASDAQ: GILD) subsidiary Kite has received approval from the U.S. Food and Drug Administration (FDA) to update the label of Yescarta (axicabtagene ciloleucel) to include overall survival (OS) data for its use as a second-line treatment for relapsed or refractory large B-cell lymphoma (r/r LBCL). This new…
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Shanghai Henlius Secures Indonesian Approval for HanSiZhuang in Small-Cell Lung Cancer
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Shanghai Henlius Biotech Inc. (HKG: 2696) has received market approval from the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan) for its anti-PD-1 monoclonal antibody, HanSiZhuang (serplulimab). This approval allows the drug to be used in the treatment of extensive-stage small-cell lung cancer (ES-SCLC). Henlius is collaborating with…
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Eli Lilly Completes Acquisition of Point Biopharma, Expanding Radiopharmaceutical Portfolio
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Eli Lilly (NYSE: LLY) has finalized its acquisition of radiopharmaceutical company Point Biopharma (NASDAQ: PNT) this week, following the clearance of the last regulatory requirement last month. As part of the acquisition, Lilly gains access to Point’s PNT2002, a PSMA-targeting radiopharmaceutical currently in Phase III trials for metastatic castration-resistant prostate…
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Fosun’s HLX42 Receives Fast-Track Designation from FDA for NSCLC Treatment
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Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196; SHA: 600196) has announced that its antibody-drug conjugate (ADC) HLX42 has received fast-track designation from the U.S. Food and Drug Administration (FDA). The drug is being co-developed with its subsidiary Shanghai Henlius Biotech Inc. (HKG: 2696) and Suzhou-based Medilink Therapeutics, specifically targeting advanced…
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Simcere Secures Approval for Local Manufacturing of Cosela, Boosting Patient Access
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China-based Simcere Pharmaceutical Group (HKG: 2096) has received supplementary filing approval for its drug Cosela (trilaciclib), enabling the transfer of its manufacturing technology from G1 Therapeutics to Simcere’s facility in Hainan. This transition paves the way for localized production of the CDK4/6 inhibitor, enhancing patient accessibility across the region. Trilaciclib,…
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Elpiscience Partners with Astellas for Bi-Specific Macrophage Engager Research
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China-based Elpiscience Biopharmaceuticals has announced a research collaboration and licensing agreement with Japan’s Astellas Pharma Inc. (TYO: 4503), focusing on Elpiscience’s innovative bi-specific macrophage engager, ES019, along with another program. The partnership will involve joint early-stage research on these two initiatives, with Elpiscience granting Astellas the option to include up…
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J&J’s Janssen Secures Exclusive Global Rights to Develop LCB84 ADC from LegoChem Biosciences
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Johnson & Johnson’s (J&J; NYSE: JNJ) pharmaceutical subsidiary, Janssen, has entered into an exclusive global agreement with South Korean-based LegoChem Biosciences (LCB; KOSDAQ: 141080) to develop and commercialize the antibody drug conjugate (ADC) LCB84. Under the terms of the agreement, LCB is set to receive $100 million in upfront payments…
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BMS Expands Oncology Portfolio with $4.1 Billion RayzeBio Acquisition
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Bristol Myers Squibb (BMS; NYSE: BMY) has announced the acquisition of RayzeBio (NASDAQ: RYZB), a clinical-stage developer of actinium-based radiopharmaceutical therapeutics (RPT), bolstering its oncology portfolio. BMS will purchase all outstanding shares of RayzeBio for an estimated $4.1 billion, with the transaction anticipated to close in the first half of…
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Amgen’s Lumakras Faces Full Approval Delay as FDA Requests New Study
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The US Food and Drug Administration (FDA) has declined to grant full approval for Amgen’s (NASDAQ: AMGN) Lumakras (sotorasib), a first-in-class KRASG12C inhibitor, for the treatment of locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer (NSCLC). The regulator has requested an additional confirmatory study, which Amgen intends to…
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Konruns Pharmaceutical Receives NMPA Go-Ahead for KC1036 Esophageal Cancer Study
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Beijing-based Konruns Pharmaceutical Co., Ltd (SHA: 603590) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for KC1036 in combination with a programmed-death 1 (PD-1) inhibitor as first-line maintenance therapy for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC). KC1036, a…
