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Shanghai Junshi Biosciences Gets FDA Approval for Phase III Study of Tifcemalimab in Small-Cell Lung Cancer
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877) has announced receiving approval from the US Food and Drug Administration (FDA) to conduct a randomized, double-blind, placebo-controlled, global multi-center Phase III study for its drug tifcemalimab (TAB004/JS004) in combination with Tuoyi (toripalimab). This consolidation therapy is intended for patients with limited-stage small-cell…
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Worg Pharmaceuticals Secures RMB 1.1 Billion in Series C Financing for Global Expansion
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Worg Pharmaceuticals, a Hangzhou-based developer of allergy drugs, has reportedly raised RMB 1.1 billion (USD 152 million) in a Series C financing round. The funding was led by DT Capital, Baron Capital, YSIM Fund, Jiansu Private Equity Fund, Kequan Fund, and a European financial institute. The proceeds will be allocated…
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AIM Vaccine Receives NMPA Approval for mRNA Vaccine Clinical Study Targeting COVID-19 Variants
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving approval from the National Medical Products Administration (NMPA) to initiate a Phase I/II clinical study for its mRNA vaccine targeting COVID-19 variants Delta and Omicron BA.5. This development marks a significant step in the company’s efforts to combat the evolving…
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Shandong Buchang Pharmaceuticals’ BC001 Gets Clinical Trial Approval for Solid Tumors
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Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a China-based pharmaceutical company, has announced receiving clinical trial approval for its investigational injectable product BC001. The drug is intended for use in combination with pucotenlimab for the treatment of advanced solid tumors, including first-line HER-2 negative advanced or metastatic gastric cancer/adenocarcinoma at…
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Sichuan Kelun-Biotech Biopharmaceutical Prices IPO at HKD 60.6 to 72.8 per Share
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Sichuan Kelun Pharmaceutical Co., Ltd’s (SHE: 002422) innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990), has priced its initial public offering (IPO) filing to the Hong Kong Stock Exchange at a range of HKD 60.6 to 72.8 per share. At an assumed offering price of HKD 60.60…
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Beijing Tiantan Biological Completes Phase I Study for Recombinant Coagulation Factor VIIa
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China-based Beijing Tiantan Biological Products Co., Ltd (SHA: 600161) has announced the conclusion of a Phase I clinical study for its recombinant human coagulation factor VIIa for injection. The company is now preparing for a Phase III study, which is expected to commence soon. This advanced treatment is aimed at…
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US FDA Issues Warning Letter to Chengdu KeCheng Fine Chemicals Over Communication Failures
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The US FDA’s Center for Drug Evaluation (CDE) issued a warning letter to China-based Chengdu KeCheng Fine Chemicals Co., Ltd earlier this month, following the company’s repeated failure to respond to the agency’s attempts to establish contact. The warning was prompted by the company’s avoidance of follow-up communications and its…
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Grand Pharmaceutical Initiates Phase I Study for TLX250-CDx in Renal Mass Imaging
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the first patient dosing in the Phase I clinical study for its TLX250-CDx (89Zr-DFO-girentuximab), an imaging agent licensed from Australia-based Telix Pharmaceuticals Ltd (ASX: TLX) in a deal valued at up to USD 225 million in 2020. Phase I Study Design…
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Teva Pharmaceutical’s Copaxone Approved by NMPA for Multiple Sclerosis Treatment in China
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The National Medical Products Administration (NMPA) website has indicated that Israel-based Teva Pharmaceutical Industries’ (NYSE: TEVA) innovative chemical drug Copaxone (glatiramer acetate) has been approved for use as a treatment for multiple sclerosis (MS) in China. This marks the second MS therapy available in China following Bristol-Myers Squibb (BMS, NYSE:…
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Fosun Pharmaceutical’s Sisram Opens Wellness Center in Chicago for Beauty and Health
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced the establishment of the Sisram Wellness Center in Chicago, United States, by its medical aesthetic solutions unit Sisram (HKG: 1696). This new venture marks the company’s expansion into providing comprehensive beauty and health experience services. Services Offered at…
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Sanyou Biopharmaceuticals and Huadong Medicine Expand Partnership on Macromolecule Therapeutics
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China-based Sanyou Biopharmaceuticals Co., Ltd has announced a licensing deal with compatriot firm Huadong Medicine Co., Ltd (SHE: 000963), expanding their strategic partnership initially formed in November 2020. The agreement focuses on the co-development of innovative bispecific antibodies (BsAbs) and antibody drug conjugates (ADCs), marking a significant step forward in…
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Daewoong Pharmaceutical Files NDA in China for Potassium-Competitive Acid Blocker Fexuclu
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South Korea-based Daewoong Pharmaceutical (KRX: 069620) has revealed that a new drug application (NDA) has been filed in China for Fexuclu/Abcito (fexuprazan) in a 40mg dosage form. Fexuclu, an in-house developed potassium-competitive acid blocker (P-CAB), represents a new generation of therapies for gastroesophageal reflux disease (GERD). Advantages of P-CABs Over…
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Insilico Medicine’s AI-Discovered Drug INS018_055 Reaches Phase II Clinical Trial Milestone
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China-based generative artificial intelligence (AI)-driven biotech Insilico Medicine has announced that its lead pipeline candidate, INS018_055, has completed first dosing in patients in a Phase II clinical trial. This small-molecule, oral anti-fibrotic drug, entirely generated by Insilico’s AI platforms, is hailed as the world’s first AI-discovered molecule to reach the…
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Biomm Secures Late-Stage Biosimilar Candidate BAT2206 from Bio-Thera Solutions
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Brazil-based biotechnology company Biomm (BVMF: BIOM3) has announced that it has in-licensed the late-stage biosimilar candidate BAT2206 from China’s Bio-Thera Solutions (SHA: 688177). This biosimilar candidate references Johnson & Johnson’s (J&J; NYSE: JNJ) subsidiary Janssen’s immunosuppressant Stelara (ustekinumab). The agreement builds upon a previous licensing and supply deal from 2020…
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AstraZeneca’s Dapagliflozin and Metformin Combo Approved by China’s NMPA for Type 2 Diabetes
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its fixed dose combination of dapagliflozin and metformin, a treatment for type 2 diabetes. This once-daily compound is now the only sustained-release formulation in China…
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Lion TCR Secures RMB 300 Million in Series B2 Financing to Advance Clinical Studies and Facility Construction
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Singapore-based clinical-stage biotechnology company Lion TCR has announced the successful completion of its Series B2 financing round, raising RMB 300 million (USD 42 million). The investment was led by Guangzhou Industrial Investment and Capital, Guoju Venture Capital, and CSPC Pharmaceutical Group. The funds will be allocated towards advancing clinical studies,…
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LianBio’s Mavacamten Receives Priority Review Status from China’s CDE for oHCM Treatment
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The Center for Drug Evaluation (CDE) has indicated on its website that China-based biotech firm LianBio (Nasdaq: LIAN) has been awarded priority review status for its drug mavacamten. This status is for the treatment of adult patients with symptomatic New York Heart Association (NYHA) heart function II-III obstructive hypertrophic cardiomyopathy…
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CSPC Pharmaceutical Group Gets NMPA Approval for JMT203 Cancer Cachexia Clinical Study
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its in-house developed Category 1 antibody, JMT203. This marks a significant step forward in the development of this novel treatment for cancer cachexia.…
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BDgene Technology Secures Over RMB 200 Million in Series B Financing Led by Lapam Capital
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Gene therapy specialist Shanghai BDgene Technology Co., Ltd has successfully raised over RMB 200 million (USD 27.7 million) in a Series B financing round. The round was led by Lapam Capital, with additional investments from Penglai Capital, Hermed Capital, Sunland Fund, and Sprinvest. The funds raised will be allocated towards…
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WuXi Biologics Partners with Pharmadule Morimatsu AB for CRDMO Expansion in Singapore
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China-based WuXi Biologics (HKG: 2269) has announced a strategic partnership with Sweden-headquartered Pharmadule Morimatsu AB (HKG: 2155), focusing on the expansion of its Contract Research, Development, and Manufacturing Organization (CRDMO) service center in Singapore. The collaboration encompasses key project lifecycle processes, including design, manufacturing, FAT (Factory Acceptance Test), installation, debugging,…
