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Hengrui Medicine’s SHR-1802 + SHR-1316 Combo Receives NMPA Approval for Solid Tumor Study
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct an open-label, multi-center Phase Ib/II clinical study of its SHR-1802 combined with SHR-1316 for advanced solid tumors. Drug Profiles Global PD-L1 MarketGlobal PD-L1 products include AstraZeneca’s Tecentriq…
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Hengrui Medicine’s SHR-A1811 Combo Receives NMPA Approval for HER2+ NSCLC Study
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib/II clinical study of SHR-A1811, a HER2-targeted antibody drug conjugate (ADC), combined with SHR-1316 or pyrotinib for advanced non-small cell lung cancer (NSCLC) with HER2…
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Ascentage Pharma Launches Olverembatinib Named Patient Program with Tanner Pharma
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China-based Ascentage Pharma (HKG: 6855) announced the launch of a Named Patient Program (NPP) for its drug olverembatinib in partnership with US-based Tanner Pharma Group. The program aims to provide access to the drug in over 100 countries and regions where it is not yet commercially available. Drug ProfileOlverembatinib is…
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Sirnaomics’ STP705 Receives Approval for Liver Cancer Trial in Taiwan
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced that it has received approval from the Ministry of Health and Welfare of Taiwan to conduct a Phase I clinical study of its therapeutic candidate STP705 for advanced liver cancer. Drug ProfileSTP705 is a siRNA (small interfering RNA) therapeutic that leverages…
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Luye Pharma’s LY01005 Meets Phase III Trial Goals in Breast Cancer Treatment
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China-based Luye Pharma Group (HKG: 2186) announced that its Phase III clinical study for LY01005 in breast cancer treatment has successfully met pre-set endpoints. The study demonstrated that LY01005 effectively controls serum estradiol to postmenenopausal levels, with clinical efficacy comparable to a control drug, achieving a non-inferiority standard. Study DetailsThe…
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Junshi Biosciences’ Toripalimab Receives EC Orphan Drug Designation for NPC
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) announced that its PD-1 inhibitor Toripalimab (trade name: Tuoyi) has received orphan drug designation (ODD) from the European Committee (EC) for the treatment of nasopharyngeal carcinoma (NPC). This marks the sixth ODD for Toripalimab in the US and Europe, following previous designations for…
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Lepu Biopharma’s Pucotenlimab Receives Conditional NMPA Approval for MSI-H/dMMR Tumors
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The National Medical Products Administration (NMPA) has granted conditional market approval to Lepu Biopharma Co., Ltd’s pucotenlimab (HX008), a programmed death 1 (PD-1) targeted humanized IgG4 monoclonal antibody (mAb). The drug is indicated for microsatellite instability-high/deficient mismatch repair (MSI-H/dMMR) expressing tumors in two patient groups: (1) those with advanced colorectal…
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Roche Posts 5% H1 Sales Growth, Led by New Drugs and Immunodiagnostics
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Swiss pharmaceutical giant Roche (SWX: ROG, OTCMKTS: RHHBY) reported a 5% year-on-year (YOY) increase in overall group sales at constant exchange rates (CER) to CHF 32.3 billion (USD 33.3 billion) for the first half of 2022. The growth was driven by new drugs for hemophilia, cancer, and neurological disorders, which…
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InnoCare’s Tafasitamab Receives First Prescription in China’s Bo’Ao Lecheng Pilot Zone
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China-based InnoCare (HKG: 9969) announced that the first prescription for its pipeline candidate tafasitamab (trade name: Monjuvi) has been issued in the Bo’Ao Lecheng Medical Tourism Pilot Zone. The drug is intended for the treatment of relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) in patients not eligible for…
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Harbin Gloria Partners with Genolmmune on PD-1 and Neoantigen Therapy for NSCLC
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China-based Harbin Gloria Pharmaceuticals Co., Ltd (SHE: 002437) has partnered with Genolmmune Therapeutics Biotechnology Co., Ltd, a BGI Genomics subsidiary focused on tumor immune cell therapy. The collaboration aims to develop Gloria’s PD-1 monoclonal antibody zimberelimab in combination with Genolmmune’s injectable Neo-T neoantigen immunotherapy for non-small cell lung cancer (NSCLC).…
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InxMed Receives $10M Debt Financing from SPD Silicon Valley Bank to Advance FAK Inhibitor IN10018
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China-based biotech firm InxMed (Nanjing) Co., Ltd announced it has received $10 million in debt financing from SPD Silicon Valley Bank. The funding will support the development of IN10018 (BI853520), a focal adhesion kinase (FAK) inhibitor licensed from iPharma Ltd and Boehringer Ingelheim. Drug ProfileIN10018 is under clinical investigation in…
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DAC Biotech’s DXC005 ADC Doses First Patient in Beijing Cancer Hospital Trial
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China-based Hangzhou DAC Biotech Co., Ltd announced the first patient enrollment and dosing of its antibody drug conjugate (ADC) DXC005 in a clinical study at Beijing Cancer Hospital’s gastrointestinal oncology department. The trial marks progress in DAC Bio’s pipeline of oncology-focused ADC candidates. Drug ProfileDXC005 combines a MUC-1 targeting antibody…
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Novartis Q2 Results Show 5% Growth, Led by Entresto and Cosentyx
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Swiss pharma giant Novartis (NYSE: NVS) reported a 5% year-on-year (YOY) revenue increase in constant currency terms to $12.79 billion in Q2 2022, though dollar sales dipped 1% due to currency strength. Earnings per share (EPS) rose 1%, or 10% excluding the $20.7 billion Roche stake sale in November 2021.…
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Eli Lilly’s Retevmo Wins Special Approval in China’s Lecheng Medical Pilot Zone
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Eli Lilly & Co. (NYSE: LLY) has secured special approval for its RET kinase inhibitor Retevmo (selpercatinib) in China’s Bo’Ao Lecheng Medical Tourism Pilot Zone. The drug will be available at the Boao Super Hospital to treat RET gene fusion-positive non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC), and…
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Sesen Bio Terminates Vicineum Development After FDA Talks, Citing Phase III Costs
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Sesen Bio Inc. (NASDAQ: SESN) announced the termination of clinical development for Vicineum (VB4-845), its next-generation antibody drug conjugate (ADC) for non-muscle invasive bladder cancer, following discussions with the U.S. FDA. The decision cited costs associated with conducting another Phase III study. Drug Profile and Licensing DealVicineum, developed on Sesen…
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Hengrui Medicine Launches Revelutamide for Metastatic Prostate Cancer in China
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Hengrui Medicine has launched revelutamide (SHR3680; trade name: Erion), China’s homegrown innovative androgen receptor (AR) inhibitor, for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden. The drug received conditional market approval from the National Medical Products Administration (NMPA) in June 2022 and was first prescribed at…
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HutchMed Initiates Phase I Study of CD47 Monoclonal Antibody HMPL-A83 in China
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China-based HutchMed (NASDAQ: HCM, HKG: 0013) announced the initiation of a Phase I clinical study for HMPL-A83, its monoclonal antibody (mAb) targeting CD47, in patients with advanced malignant tumors. The first patient was dosed on July 15, 2022. Study DetailsThe multi-center, open-label Phase I trial (NCT05429008) will evaluate the safety,…
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ImmuneOnco’s IMM2902 Receives FDA Fast-Track Designation for CD47/HER2 Targeting
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd announced that the U.S. Food and Drug Administration (FDA) has granted fast-track designation to its bispecific antibody (BsAb)-receptor recombinant protein IMM2902, targeting human CD47 and HER2. The product is the only CD47/HER2 BsAb to enter clinical trials globally. Drug ProfileIMM2902 inhibits tumor cell growth by…
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Luye Pharma’s Lurbinectedin Receives Hainan Approval for SCLC Treatment
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China-based Luye Pharma Group (HKG: 2186) announced approval from the Hainan Medical Products Administration for lurbinectedin (LY01017), an RNA polymerase II inhibitor, to treat metastatic small-cell lung cancer (SCLC) in patients with disease progression after chemotherapy. The drug will be available through Hainan’s Boao Lecheng International Medical Tourism Pilot Zone,…
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CStone Pharmaceuticals’ Gavreto Wins Hong Kong Approval for RET Fusion NSCLC
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CStone Pharmaceuticals (HKG: 2616) announced that its RET inhibitor Gavreto (pralsetinib) has received marketing approval in Hong Kong for treating adults with RET fusion-positive metastatic non-small cell lung cancer (NSCLC). The drug, licensed from US-based Blueprint Medicines in June 2018, was approved based on data from the global Phase I/II…
