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Luye Pharma’s Lurbinectedin Gains Priority Review Status for SCLC Treatment
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The Center for Drug Evaluation (CDE) website indicates that China-based Luye Pharma Group’s (HKG: 2186) lurbinectedin (LY01017), an RNA polymerase II inhibitor, is set to obtain priority review status for the treatment of metastatic small cell lung cancer (SCLC) with tumor progression during or after platinum-based chemotherapy. Development and Mechanism…
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Guangdong Zhongsheng’s RAY1216 Receives Conditional Approval for COVID-19 Treatment
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced that it has received conditional marketing approval from the National Medical Products Administration (NMPA) for its drug candidate RAY1216, a 3CL protease (3CLpro) inhibitor. The drug is set to be assessed as a treatment for mild to moderate COVID-19. Mechanism…
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Hengrui Pharmaceuticals’ HRS-5965 Receives NMPA Approval for Clinical Study in Hemolytic Anemia
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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 clinical study for its investigational drug HRS-5965. The study will focus on complement-mediated hemolytic anemia, including conditions such as paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic…
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Sunshine Guojian Completes Patient Enrollment for SSGJ-611 Phase II Study in Atopic Dermatitis
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China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd, a subsidiary of 3SBio Inc. (HKG: 1530), has announced the completion of patient enrollment in a China-based Phase II clinical study for its SSGJ-611, an IL-4Rα monoclonal antibody (mAb). The drug is being evaluated as a treatment for moderate to severe atopic dermatitis…
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Henlius Biotech’s Serplulimab Accepted for EMA Review for ES-SCLC Treatment
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Shanghai Henlius Biotech (HKG: 2696) has announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for its programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab). The drug is filed for its first indication as a first-line treatment in combination with chemotherapy for extensive-stage small cell lung cancer…
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Sino Biopharmaceutical’s F-star Therapeutics Signs Second Licensing Deal with Takeda
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced a second licensing agreement between its recently acquired subsidiary, F-star Therapeutics Inc. (NASDAQ: FSTX), and Japan-based Takeda Pharmaceutical Co., Ltd (TYO: 4502). The deal provides Takeda with a next-generation tumor immunotherapy bispecific antibody (BsAb), with the specific target or other molecule details undisclosed.…
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AstraZeneca’s Calquence Receives Conditional Approval in China for MCL
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AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received conditional market approval in China for its next-generation Bruton’s tyrosine kinase (BTK) inhibitor, Calquence (acalabrutinib). The drug is approved for the first indication in adults with mantle cell lymphoma (MCL) who have received at least one prior therapy. Clinical Trial…
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Biohaven Acquires Global Rights for Dual TYK2/JAK1 Inhibitor BHV-8000 from Highlightll
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US-based Biohaven Ltd. (NYSE: BHVN) has announced the acquisition of global rights, excluding China regions, for the development of an oral, brain-penetrant, dual inhibitor of Tyrosine Kinase 2 (TYK2) and Janus Kinase 1 (JAK1) for the treatment of brain disorders. The compound, BHV-8000 (previously TLL-041), was licensed from Hangzhou Highlightll…
