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Baheal Partners with AstraZeneca for Commercial Rights to Onglyza
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China-based health services and distribution giant Baheal Pharmaceutical Group has struck a partnership with AstraZeneca (AZ, NASDAQ: AZN), securing commercial operation rights to the UK major’s Onglyza (saxagliptin). This strategic move aims to enhance the distribution and accessibility of the diabetes treatment in China. Saxagliptin ProfileSaxagliptin, a dipeptidyl peptidase-4 (DPP4)…
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EQRx Shifts Strategy Amid FDA Feedback on China-Sourced Data
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US-based EQRx Inc. (Nasdaq: EQRX), a biopharma originally established with the aim of “radically” disrupting pricing in the US market using China-licensed products, has rejigged its strategy in light of recent communications with the US FDA. The firm is abandoning a low-price strategy and will apply “market-based pricing” to any…
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CDE Prioritizes Review for Jiedi Pharma’s Mitotane and Other Key Drugs
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The Center for Drug Evaluation (CDE) website indicates that market filings for several key drugs, including Jiedi Pharma’s mitotane, Pfizer’s ritlecitinib, Northrop Grumman’s trientine, and Ark Bio’s ziresovir, have been prioritized for review. This move highlights the CDE’s efforts to expedite the approval process for drugs with significant therapeutic potential.…
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CanSino Biologics’ Inhalable COVID-19 Vaccine Authorized in Morocco
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China-based CanSino Biologics (SHA: 688185, HKG: 6185) has announced that it has received emergency use authorization (EUA) for its inhalable recombinant novel coronavirus vaccine (adenovirus type 5 vector) in Morocco. This marks a significant milestone in the global deployment of innovative COVID-19 vaccines. Convidecia ProfileConvidecia, the recombinant novel coronavirus vaccine…
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Luye Pharma’s Biosimilar LY06006/BA6101 Approved for Osteoporosis Treatment
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China-based Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its pipeline drug LY06006/BA6101, a biosimilar version of Amgen’s Xgeva (denosumab). The approval is for the treatment of osteoporosis in postmenopausal women at high risk of…
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Lundbeck’s Eptinezumab Launches in Boao Lecheng for Migraine Treatment
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Lundbeck’s (FRA: LDBB) Eptinezumab has been launched in the Boao Lecheng International Medical Tourism Zone, marking it as the first innovative drug available in the region for migraine treatment. This milestone was announced on November 10, 2022, at a joint press conference held by the Hainan Boao Lecheng International Medical…
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Novartis Partners with Alibaba Health to Enhance Patient Medication Accessibility
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The 5th China International Import Expo (CIIE) saw the announcement of a partnership between Swiss pharmaceutical giant Novartis (NYSE: NVS) and China-based Alibaba Health Information Technology Ltd (HKG: 0241). The collaboration aims to utilize digitization to enhance patient medication accessibility and provide one-stop health management services. Financial details of the…
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RemeGen’s Telitacicept Set for Breakthrough Therapy Designation in Myasthenia Gravis
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The Center for Drug Evaluation (CDE) website indicates that China-based RemeGen Co., Ltd’s (HKG: 9995, SHA: 688331) novel fusion protein telitacicept is set to receive breakthrough therapy designation (BTD) status for the treatment of myasthenia gravis (MG). This marks a significant step forward in addressing a rare and challenging autoimmune…
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Harbour BioMed and Moderna Ink Licensing Deal for Oncology Immunotherapies
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Harbour BioMed (HKG: 2142), a biotech company with operations in the United States, the Netherlands, and Suzhou, China, has announced a licensing agreement between its wholly owned subsidiary Nona Biosciences and US mRNA specialist ModernaTX, Inc. (NASDAQ: MRNA). The collaboration will focus on discovering and developing nucleic acid-based immunotherapies for…
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CStone’s PD-L1 Inhibitor Sugemalimab Achieves Primary Endpoint in Gastric Cancer Study
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China-based CStone Pharmaceuticals (HKG: 2616) has announced that its GEMSTONE-303 study for the programmed death-ligand 1 (PD-L1) inhibitor sugemalimab, combined with chemotherapy as a first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (GC/GEJC) with PD-L1 expression ≥ 5%, has reached the primary endpoint of progression-free survival (PFS). This…
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BeiGene’s Brukinsa Receives Marketing Approval in Brazil
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced that it has received marketing approval in Brazil for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The in-house developed drug is now approved for the treatment of Waldenström’s macroglobulinemia (WM) and relapsed/refractory (r/r) marginal zone lymphoma (MZL)…
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Sinocelltech’s SCTV01E Vaccine Receives NMPA Approval for Phase II Study
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a bridging Phase II clinical study assessing the safety and immunogenicity of its SCTV01E vaccine. The quadrivalent (Alpha + Beta + Delta + Omicron variants) S trimer protein…
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3SBio’s Thrombopoietin Study in Pediatric ITP Reaches Primary Endpoint
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China-based 3SBio Inc. (HKG: 1530) has announced that its multi-center, randomized, double-blind, placebo-controlled study assessing the safety, efficacy, and pharmacokinetics of thrombopoietin in chronic primary immune thrombocytopenia (ITP) in children or adolescents has reached its pre-set primary endpoint. The results of the statistical analysis showed that the study group’s superiority…
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Zenas BioPharma Completes $118M Series B Financing to Advance Obexelimab
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Autoimmune disease drug developer Zenas BioPharma, which is based in the US and China, has announced the completion of a Series B financing round at USD 118 million. The round was led by Enavate Sciences, with participation from Longitude Capital, Vivo Capital, Rock Springs Capital, Perceptive Advisors, Agent Capital, Pivotal…
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LianBio Initiates Phase I Study of SHP2 Inhibitor BBP-398 in China
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Sino-US biotech LianBio has announced the first patient dosing in a Phase I clinical study for its SHP2 inhibitor BBP-398 in Chinese patients with advanced solid tumors. This marks a significant step forward in the development of BBP-398, which targets the SHP2 protein-tyrosine phosphatase. SHP2 links growth factor, cytokine, and…
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Innovex Medical Files for IPO in Hong Kong to Boost Product Development
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Innovex Medical Co., Ltd, a non-vascular interventional surgery solutions provider based in Shanghai, has filed an initial public offering (IPO) with the Hong Kong Stock Exchange. The IPO is co-sponsored by Goldman Sachs and CICC. While the price has not been disclosed at this stage, the proceeds will be used…
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Ascentage Pharma Gains CDE Approval for Phase I Study of APG-5918
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Suzhou-based Ascentage Pharma (HKG: 6855) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a multi-center, open-label, dose escalation and expansion Phase I study. The study will assess the safety, pharmacokinetics, and efficacy of its embryonic ectoderm development (EED) inhibitor APG-5918. The drug…
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Zai Lab Reports 33% YOY Revenue Growth in Q3 2022
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Chinese biopharmaceutical firm Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) released its Q3 2022 earnings report, showing total revenues of USD 57.5 million for the three-month period, up 33% year-on-year (YOY) and a 19% increase compared to USD 43.1 million for the same period in 2021. Research and Development (R&D)…
