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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 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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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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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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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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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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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 (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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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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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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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 (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 (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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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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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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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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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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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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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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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…