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BMS Regains Full Rights to Mavacamten in China and Asia from LianBio
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Bristol-Myers Squibb (BMS; NYSE: BMY) is set to regain full control of mavacamten, a treatment for hypertrophic cardiomyopathy (HCM), from China’s LianBio (NASDAQ: LIAN) in China and other Asian markets. This strategic move follows LianBio’s previous acquisition of development rights for mavacamten in Greater China, Singapore, and Thailand from MyoKardia…
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Sihuan Pharmaceutical Gains NMPA Approval for Innovative Type 2 Diabetes Treatment
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its insulin degludec, liraglutide to treat type 2 diabetes. This marks a significant step forward in the development of novel treatments for diabetes in China.…
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Jiangsu Aidea’s HIV-1 Drug ACC017 Accepted for NMPA Review in China
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China-based Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced that the National Medical Products Administration (NMPA) has accepted a clinical trial filing for its Category 1 drug, ACC017, for the treatment of HIV-1 infection in combination with other antiretroviral drugs. Mechanism and Pre-Clinical FindingsACC017 is a human immunodeficiency virus…
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Shandong Luoxin’s LX-039 Demonstrates Promise in Phase I Oncology Study at ESMO
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Shandong Luoxin Pharmaceutical Group Stock Co., Ltd (SHE: 002793), a China-based pharmaceutical innovator, has published data from a Phase I clinical study for its novel anti-tumor drug, LX-039. This oral selective estrogen receptor modulator (SERD) was in the spotlight at the European Society for Medical Oncology (ESMO) Congress 2023, where…
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Kintor’s Proxalutamide Shows Promise in Metastatic Breast Cancer Study at ESMO
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China-based Kintor Pharmaceutical Ltd (HKG: 9939) has published the latest data from a Phase Ic clinical study evaluating its proxalutamide in combination with endocrine therapies (ETs) for metastatic breast cancer. The findings were presented at the European Society for Medical Oncology (ESMO) Congress 2023, shedding light on the drug’s potential…
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Walvax Biotechnology Secures BPOM Approval for Weuphoria Pneumococcal Vaccine
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced that it has received market approval from the Indonesian Food and Drug Control Agency (BPOM) for its Weuphoria, a 13-valent pneumococcal polysaccharide conjugate vaccine (PCV-13). This approval is a significant milestone for Walvax as it expands its reach into the Indonesian…
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NMPA Implements New Measures for Drug Manufacturing Outsourcing by MAHs
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The National Medical Products Administration (NMPA) has issued a notice detailing new supervision and management measures for the outsourcing of manufacturing duties by Marketing Authorization Holders (MAHs). These measures take immediate effect and aim to enhance the regulatory framework surrounding drug production outsourcing. Regulatory Requirements for OutsourcingApplicants seeking to outsource…
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Ascentage Pharma’s Pelcitoclax Shows Promise in ESMO Study for NSCLC
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Suzhou-based pharmaceutical company Ascentage Pharma (HKG: 6855) has published the latest results from a Phase Ib study of its pelcitoclax (APG-1252), a dual inhibitor of BCL-2 and BCL-xL proteins, in combination with AstraZeneca’s Tagrisso (osimertinib) for the treatment of EGFR-mutated non-small cell lung cancer (NSCLC). The findings were presented at…
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