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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…
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Simcere Affiliate Shanghai Simnova Biotech Gets China Nod for CAR-T Therapy SNC109
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Shanghai Simnova Biotech Co., Ltd, known as Simnova outside of China and an affiliate of Simcere Investment Group, has received tacit clinical trial approval from Chinese authorities for its SNC109, an in-house developed treatment for recurrent glioblastoma. SNC109 is a dual chimeric antigen receptor (CAR)-T cell therapy designed on Simnova…
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Biocytogen and Lepu Biotechnology Develop WT1-Targeted Trispecific Antibody for Cancer Treatment
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Biocytogen Pharmaceuticals (Beijing) Co., Ltd, (HKG: 2315) and Lepu Biotechnology Co., Ltd (HKG: 2157) have announced significant progress in the co-development of their trispecific T cell connector, having identified a WT1/HLA-A02 targeted T-cell connector, WT1×CD3×4-1BB trispecific antibody, as part of their collaboration initiated last year. Pre-clinical data for this product…
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Aidea Pharmaceutical Co. Terminates ACC006 Technology Transfer Deal with Lixin Bio
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Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has resolved to terminate its technology transfer agreement with Guangzhou Lixin Biological Technology Co., Ltd. concerning the drug candidate ACC006. Initially inked in December 2021, the agreement saw Aidea Pharma bestow upon Lixin Bio the rights to its cancer drug candidate ACC006 for…
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AstraZeneca to Acquire China’s Gracell Biotechnologies in $1.2 Billion Deal
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Pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced its intention to fully acquire Gracell Biotechnologies Inc., (NASDAQ: GRCL), a China-based developer of chimeric antigen receptor (CAR) T cell therapies. This marks the first major merger and acquisition (M&A) deal by a foreign company targeting one of China’s newest generation biotechs.…
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FDA Grants Priority Review to MSD and Daiichi Sankyo’s ADC for Lung Cancer
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The US Food and Drug Administration (FDA) has accepted under priority review a filing from Merck, Sharp & Dohme (MSD; NYSE: MRK) and Daiichi Sankyo (TYO: 4568) for their jointly developed antibody-drug conjugate (ADC) patritumab deruxtecan. The treatment is intended for patients with locally advanced or metastatic EGFR-mutated non-small cell…
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J&J’s Rybrevant-Lazertinib Combo Accepted for FDA Review in NSCLC
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The US Food and Drug Administration (FDA) has accepted for review Johnson & Johnson’s (J&J; NYSE: JNJ) application for Rybrevant (amivantamab), a bispecific antibody, in combination with lazertinib, a tyrosine kinase inhibitor (TKI), for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon…
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Shouyao Holdings Receives Ethical Approval for Phase III Study of ALK Inhibitor SY-3505
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Beijing-based Shouyao Holdings (Beijing) Co., Ltd (SHA: 688197) has announced that it has received ethical approval to conduct a pivotal Phase III clinical study for its third-generation anaplastic lymphoma kinase (ALK) inhibitor, SY-3505. The study is a randomized, controlled, multi-center trial designed to assess the efficacy and safety of SY-3505…
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Hengrui Pharmaceuticals-Backed Nanjing Tianyinshan Hospital Opens as Class 3A Oncology Specialist Center
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Nanjing Tianyinshan Hospital, a private Class 3A oncology specialist hospital invested in by Hengrui Pharmaceuticals (SHA: 600276), commenced operations on December 22. The hospital is headed by Professor Qin Shukui, a prominent figure in the field of oncology. Situated in the Nanjing Jiangning High Tech Zone, the hospital spans a…
