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CStone Launches Patient Assistance Program for IDH1 Inhibitor Tibsovo
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CStone Pharmaceuticals (HKG: 2616) has announced the launch of a patient assistance scheme to support access to Tibsovo (ivosidenib), the world’s first-in-class IDH1 inhibitor used to treat leukemia. The initiative was launched this month by the Shanghai Life Oasis Public Service Center, with support from the Beijing Health Alliance Charitable…
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HutchMed Announces Initial Results from FRUTIGA Phase III Study
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China-based Hutchison China Meditech (HutchMed; NASDAQ: HCM, HKG: 0013) has announced the initial results from the FRUTIGA Phase III study, which evaluated Elunate (fruquintinib) combined with paclitaxel in 703 Chinese patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJ). The study aimed to assess the efficacy and safety of…
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BRL Medicine Raises RMB 200M in Series B Financing for CGT Development
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BRL Medicine Inc., a cell and gene therapy (CGT) developer based in Shanghai, has reportedly raised over RMB 200 million (USD 28.3 million) in a Series B financing round. The round was led by Shanghai FTZ Fund, with participation from Oriental Fortune Capital, Tasly Capital, Betta Biomedical Industry Fund, and…
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Peijia Medical Enrolls First Patient in HighLife TSMVR Study
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China’s Peijia Medical Limited (HKG: 9996) has announced the enrollment of the first patient and the implantation in a regulatory clinical study for its HighLife transcatheter septal mitral valve replacement (TSMVR) system. This marks a significant step forward in the development and potential market approval of the device. Study Design…
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Acotec Scientific Secures FDA 510(k) Approval for Vericor Catheter
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced that it has received a 510(k) license from the US FDA for its Vericor, a peripheral support catheter designed to improve peripheral vascular pathways. This approval marks a significant milestone for Acotec in expanding its presence in the US medical device…
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CStone Pharmaceuticals Suspends Operations at Suzhou Plant to Cut Costs
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CStone Pharmaceuticals (HKG: 2616) has decided to suspend manufacturing operations at its Suzhou industrialization plant, according to a recent statement. The decision was made due to the lack of a clear plan for mass production at present and to reduce enterprise operating costs. According to Healthcare Executive, the Chinese firm…
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Daxiang Biotech Raises RMB 100M in Pre-Series B Financing for Organoid-on-a-Chip
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Beijing-based Daxiang Biotech Co., Ltd., a leading domestic company in the organoid-on-a-chip field, has reportedly raised close to RMB 100 million (USD 14.18 million) in a Pre-Series B financing round. The round was led by Proxima Venture Capital, with participation from Qiandao Investment Fund, Shaanxi Growth Enterprise Guide Fund, and…
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Harbin Gloria Pharmaceuticals Faces Change in Control Amid Bankruptcy
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China-based Harbin Gloria Pharmaceuticals Co., Ltd (SHE: 002437) has disclosed that its controlling shareholder, Harbin Gloria Group Co., Ltd, has entered “bankruptcy liquidation” status. Previously, the group had been undergoing a “reorganization” process. The bankruptcy is expected to result in a change of control at Gloria Pharmaceuticals; however, the company…
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HitGen Partners with Daewoong Pharmaceutical for Drug Discovery
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China-based HitGen Inc. (SHA: 688222) has announced a research collaboration agreement with South Korea’s Daewoong Pharmaceutical Co., Ltd. Under the deal, HitGen will leverage its DNA-encoded library (DEL) technology platform to discover compounds that bind to specific targets identified by Daewoong. Financial details of the collaboration were not disclosed. Daewoong…
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Henlius Biotech’s BRAF V600E Inhibitor HLX208 Approved for Clinical Study in China
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China-based Shanghai Henlius Biotech (HKG: 2696) has announced that the National Medical Products Administration (NMPA) has approved a Phase Ib/II clinical study for its BRAF V600E inhibitor HLX208. The study will evaluate the combination of HLX208 with HaiSiZhuang (serplulimab) plus standard therapies (cetuximab or trametinib) for the treatment of advanced…
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AstraZeneca Reports 19% YOY Revenue Growth in Q3 2022
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UK-based pharmaceutical giant AstraZeneca Plc (AZ, NASDAQ: AZN) released its Q3 2022 earnings report, showing continued growth with a 19% year-on-year (YOY) expansion in product revenues to USD 10.98 billion (all growth figures in constant exchange rate terms). Business Unit PerformanceGrowth was led by the Oncology division, which saw a…
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FDA Approves Phase Ib Study for Jiangsu Yahong’s APL1401 in Ulcerative Colitis
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China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176) has announced that it has received approval from the US FDA to conduct a Phase Ib clinical study for its drug candidate APL1401. The trial will evaluate APL1401 as a treatment for moderate to severe active ulcerative colitis…
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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…
