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Sichuan Kelun Pharmaceutical Secures Exclusive Rights to TBM-001 for Bone Metastasis Diagnosis
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), through its innovative drug development subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has entered into an exclusive licensing agreement with the Affiliated Hospital of Southwest Medical University. The agreement pertains to TBM-001, a radionuclide drug conjugate (RDC) designed for early diagnosis and…
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Chongqing Lummy Pharmaceutical’s Subsidiary Receives NMPA Approval for CUD002 mRNA Vaccine
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Chongqing Lummy Pharmaceutical Co., Ltd (SHE: 300006), through its subsidiary Sichuan Cunde Therapeutics Co., Ltd, has received clinical trial approval from the National Medical Products Administration (NMPA) for the CUD002 injection. This mRNA-edited DC (dendritic cell) tumor therapeutic vaccine product is based on patient tumor neoantigens, marking a significant step…
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Dizal Pharmaceutical’s Golidocitinib NDA Accepted for Review by NMPA
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China-based Dizal Pharmaceutical Co., Ltd (SHA: 688192) has announced that the National Medical Products Administration (NMPA) has accepted for review its New Drug Application (NDA) for golidocitinib, a first-in-class JAK1 inhibitor. The drug candidate is filed for the initial indication of treating recurrent refractory peripheral T-cell lymphoma (r/r PTCL). Supporting…
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EMA Approves Astellas’ Xtandi for Non-Metastatic Hormone-Sensitive Prostate Cancer
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The European Medicines Agency (EMA) has granted Japan-based Astellas (TYO: 4503) an indication extension approval for its androgen receptor inhibitor Xtandi (enzalutamide). This approval expands the use of Xtandi as a treatment for non-metastatic hormone-sensitive prostate cancer (nmHSPC) in patients with high-risk biochemical recurrence (BCR) who are unsuitable for salvage-radiotherapy.…
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Boehringer Ingelheim Gets NMPA Approval for Brigimadlin Safety and Efficacy Study in China
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Germany-based Boehringer Ingelheim (BI) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct the Brightline-2 study in China. The study will assess the safety and efficacy of the company’s MDM2-p53 antagonist, brigimadlin (BI 907828), in patients with locally advanced/metastatic, MDM2 amplification, TP53 wild-type…
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AstraZeneca’s Tagrisso Combination Therapy Shows Improved Efficacy in EGFR-mutated NSCLC
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UK-headquartered AstraZeneca (AZ; NASDAQ: AZN) has announced interim Phase III data demonstrating that the addition of pemetrexed plus cisplatin/carboplatin chemotherapy to tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) improves therapeutic effects in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). The combination therapy reduced the risk of…
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Janssen Reports Positive Results from Phase Ib/II Study of Rybrevant Combo in EGFR-mutated NSCLC
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Johnson & Johnson (J&J; NYSE: JNJ) subsidiary Janssen has provided an update on an ongoing Phase Ib/II study cohort assessing the safety and pharmacokinetics of the bispecific antibody (BsAb) Rybrevant (amivantamab) in combination with tyrosine kinase inhibitor (TKI) lazertinib and chemotherapy for the treatment of relapsed/refractory EGFR-mutated non-small cell lung…
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AstraZeneca’s Enhertu Shows Promising Results in Phase II HER2-mutant NSCLC Trial
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AstraZeneca (AZ; NASDAQ: AZN) has released early data from a Phase II trial investigating the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) in patients with HER2-mutant unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC). The trial assessed the efficacy and safety of different dosages of Enhertu, revealing that while a…
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JW Therapeutics and 2seventy Bio Expand Partnership for Cell Therapy Development
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China-based cell therapy firm JW Therapeutics (HKG: 2126) and US biotech 2seventy Bio Inc., (NASDAQ: TSVT) have announced plans to build on their 2022 collaboration agreement. The latest deal grants JW Therapeutics the option to develop up to two additional candidate drugs from 2seventy Bio’s product portfolio, including a T…
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Exelixis Secures Global Rights to Develop Insilico Medicine’s USP1 Inhibitor ISM3091
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China-based generative artificial intelligence (AI)-driven biotech Insilico Medicine has entered into an exclusive license agreement with US firm Exelixis Inc., (NASDAQ: EXEL), granting Exelixis global rights to develop and commercialize ISM3091, a potentially best-in-class small molecule inhibitor of USP1. USP1 has been identified as a synthetic lethal target in the…
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HutchMed Advances Tazverik Phase II Trial for Follicular Lymphoma in China
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China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced the completion of patient enrollment in a bridging study for Tazverik (tazemetostat) in China. Tazverik, originated by US firm Epizyme Inc., was licensed to HutchMed for development in Greater China in an agreement reached in August 2021. Tazverik’s Background and Previous ApprovalsThe…
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Amgen’s Lumakras Combo Shows Promising Results in KRAS-mutated NSCLC Early-Stage Trial
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Amgen (NASDAQ: AMGN) has announced positive early-stage data for its KRASG12C inhibitor Lumakras (sotorasib) when combined with carboplatin and pemetrexed in the treatment of KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC) in adults. The confirmed objective response rate (ORR) and disease control rate (DCR) in treatment-naive patients were 65%…
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Gilead’s Trodelvy Combo with MSD’s Keytruda Shows Promise in NSCLC Phase II Trial
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Gilead (NASDAQ: GILD) has announced interim data from a Phase II trial assessing the antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan) in combination with Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 Keytruda (pembrolizumab) for first-line advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations. The interim results…
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Shanghai Junshi Biosciences to Acquire Stake in Anlingke Biopharmaceutical for Cancer Therapy Programs
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China-based Shanghai Junshi Biosciences Co., Ltd (HKG: 1877; SHA: 688180) has announced its intention to acquire a 9.45% stake in start-up biopharma company Shanghai Anlingke Biopharmaceutical Co., Ltd for a consideration of RMB 30.6 million. This strategic acquisition is set to be completed through the transfer of two cancer therapy…
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Oriomics Secures Series B+ Funding to Advance Liver and Digestive Cancer Screening
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Hangzhou-based Oriomics, a specialist in cancer screening based on circulating tumor DNA (ctDNA) methylation detection, has reportedly raised close to RMB 100 million (USD 13.7 million) in a Series B+ financing round. The round was led by Fortune Capital, with additional investments from Tao Capital, Hotgen Biotech, and the company’s…
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Abbisko Therapeutics Receives EMA Approval for Phase III Study of Pimicotinib for TGCT
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the European Medicines Agency (EMA) to conduct a Phase III clinical study for its Category 1 innovative drug ABSK021 (pimicotinib), which is being assessed as a treatment for tendon sheath giant cell tumor (TGCT).…
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Allist Pharmaceuticals and ArriVent Biopharma Release Promising Interim Data on Furmonertinib for NSCLC
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Shanghai-based biotech Allist Pharmaceuticals Co., Ltd and its US partner ArriVent Biopharma Inc. have jointly released interim data from a Phase Ib trial at the 2023 World Conference on Lung Cancer (WCLC) meeting. The trial assessed the efficacy of furmonertinib as a treatment for non-small cell lung cancer (NSCLC), specifically…
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EMA Reviews Janssen’s Balversa for Advanced Urothelial Carcinoma with FGFR3 Alterations
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The European Medicines Agency (EMA) has accepted for review a filing made by the Janssen unit of Johnson & Johnson (J&J; NYSE: JNJ) for the tyrosine kinase inhibitor (TKI) Balversa (erdafitinib) as a treatment for locally advanced unresectable or metastatic urothelial carcinoma (UC) in adults with susceptible fibroblast growth factor…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for Phase Ib/III Study of Dalpiciclib in mHSPC
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, double-blind Phase Ib/III clinical study. The study will assess the combination of dalpiciclib (SHR6390) with abiraterone plus prednisone in patients with metastatic hormone…
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Merck’s Keytruda Approved in China for MSI-H/dMMR Advanced Solid Tumors: A Biomarker-Driven Milestone
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US pharmaceutical major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its programmed drug Keytruda (pembrolizumab) has been approved in China for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene deficient (dMMR) advanced solid tumors. This includes colorectal cancer patients who have…
