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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…
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Jiangxi Jemincare Group Secures Clinical Trial Approvals for Six Drugs in China and the US
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China-based Jiangxi Jemincare Group (SHA: 603222) has announced receiving clinical trial approvals for six of its Category 1 chemical drugs in China and the United States, with indications spanning cancer, kidney diseases, and infectious diseases. JMKX003801, approved for study in China for severe infections caused by Gram-negative bacteria, has demonstrated…
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CStone Pharmaceuticals Regains Exclusive Rights to Tibsovo in Greater China and Singapore
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CStone Pharmaceuticals (HKG: 2616), a China-based biopharmaceutical company, has announced an agreement with French pharmaceutical company Servier that returns exclusive development, manufacturing, and commercialization rights to Tibsovo (ivosidenib) in Greater China, which includes mainland China, Hong Kong, Macau, and Taiwan, as well as Singapore. Originally developed by US-based Agios Pharmaceuticals,…
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Sanofi Halts Development of Tusamitamab Ravtansine After Missed Trial Endpoints
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Sanofi (NASDAQ: SNY) has announced the discontinuation of its antibody-drug conjugate (ADC) tusamitamab ravtansine following disappointing results from a Phase III trial in metastatic non-squamous (NSq) non-small cell lung cancer (NSCLC) patients with high CEACAM5 expression. The trial did not meet its dual primary endpoints, as indicated by an interim…
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CStone Pharmaceuticals Disbands Sales Team for Gavreto After NRDL Setback
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CStone Pharmaceuticals (HKG: 2616) has confirmed media reports regarding the dismissal of its sales team for Gavreto (pralsetinib), marking a significant shift in the Chinese company’s commercial strategy for its first product to reach the market. Gavreto, which was licensed to Allist Pharmaceuticals Co., Ltd in November 2023, did not…
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Sino Biopharmaceutical Completes Enrollment for Phase III Trial of Anlotinib in Soft Tissue Sarcoma
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Sino Biopharmaceutical Ltd (HKG: 1177), a China-based pharmaceutical giant, has announced the completion of patient enrollment for a Phase III clinical trial of anlotinib, marketed under the trade name FOCUS V, in conjunction with chemotherapy for first-line treatment of advanced soft tissue sarcoma. The trial, conducted by Jiangsu Chia Tai…
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Legend Biotech’s Carvykti Therapy to Include Myeloid Neoplasms Warning in Label Update
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GenScript Biotech Corporation (HKG: 1548), a China-based Contract Research Organization (CRO), has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), will update the warning label for its BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), to account for the potential risk of myeloid neoplasms in patients…
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AstraZeneca Advances to Phase III with PD-1xTIGIT BsAb for Biliary Tract Cancer
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AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, is set to initiate a Phase III study for its PD-1xTIGIT bispecific antibody (BsAb) rilvegostomig in combination with chemotherapy for patients with biliary tract cancer (BTC) following surgical resection. The double-blind, placebo-controlled, global trial aims to assess the efficacy and tolerability of…
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Lee’s Pharmaceutical’s Socazolimab Becomes China’s First PD-L1 mAb for Cervical Cancer
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Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) has secured in-licensed rights for socazolimab, a treatment for recurrent-metastatic cervical cancer, according to the National Medical Products Administration (NMPA) website. This drug marks the first programmed-death ligand 1 (PD-L1) monoclonal antibody (mAb) for cervical cancer in China. Socazolimab, originally developed by US-based Sorrento…
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Jiangsu Hengrui Pharmaceuticals Wins NMPA Approvals for SLE and Lymphoma Drug Candidates
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has announced that it has received separate clinical trial approvals from China’s National Medical Products Administration (NMPA) for two of its drug candidates, SHR0302 and SHR2554. SHR0302 is anticipated to treat systemic lupus erythematosus (SLE), while SHR2554 is…
