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Novartis’ Tislelizumab Faces FDA Hurdle in First-Line NSCLC Monotherapy
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Novartis disclosed during its Q2 2022 earnings call that the U.S. FDA deemed clinical data for BeiGene’s PD-1 inhibitor tislelizumab insufficient to support an approval filing for first-line monotherapy in non-small cell lung cancer (NSCLC). Development will pivot to second-line combination therapy for NSCLC. FDA FeedbackThe FDA cited inadequate representation…
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Latin America Accelerates COVID-19 Fight with Vaccine and Treatment Initiatives Across the Region
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Latin America is ramping up its contributions to the worldwide race for COVID-19 vaccines and treatments. Cuba’s state-owned BioCubaFarma, through its Center for Genetic Engineering and Biotechnology (CIGB), has designed a vaccine candidate and is advancing its development in collaboration with China’s Research and Development Center in Yongzhou, Hunan’s Industrial…
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Exegenesis Bio Secures Multi-Million Dollar Series B Financing for Gene Therapy Pipeline
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Exegenesis Bio Inc., a leading gene therapy company, has successfully completed a Series B financing round, raising tens of millions of dollars. The round was led by Legend Capital, with Boyuan Capital, Taikang Capital, and previous investors Xianfeng Qiyun and Kaitong Capital participating. The funds raised will be directed towards…
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Genscript’s CAR-T Therapy JNJ-4528 Demonstrates 100% Effective Rate in Long-Term Myeloma Study
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Genscript Biotech Corporation (HKG: 1548), a leading China-based Contract Development and Manufacturing Organization (CDMO), has announced the publication of long-term follow-up data from the Phase 1b/2 study, CARTITUDE-1. The study, conducted in partnership with Janssen Pharmaceutical, focuses on the chimeric antigen receptor (CAR)-cell therapy JNJ-4528 for the treatment of recurrent…
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Asymchem Laboratories Secures RMB 2.31 Billion Private Placement with Hill House Capital Subscription
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Asymchem Laboratories (Tianjin) Co., Ltd, a renowned Contract Development and Manufacturing Organization (CDMO) based in China and listed on the SZSE under the ticker (002821), has unveiled a significant private placement initiative. The company will issue 18,700,000 A shares at a price of RMB 123.56 per share. Hill House Capital,…
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Innovent Biologics and Eli Lilly & Co.’s Tyvyt Achieves Primary Endpoints in Phase II ESCC Clinical Study
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Innovent Biologics (HKG: 1801), a prominent biotech firm headquartered in Suzhou, China, and Eli Lilly & Co. (Nasdaq: LLY), a titan of the US pharmaceutical industry, have jointly declared a significant milestone in the Phase II clinical study known as ORIENT-2. The study focuses on the co-developed anti-programmed death-1 (PD-1)…
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Luye Pharma Expands Latin American Reach with Exclusive Seroquel Promotion Agreement in Brazil and Mexico
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Luye Pharma Group (HKG: 2186), a leading Chinese pharmaceutical conglomerate, has declared that its wholly-owned subsidiary, Luye Hong Kong Limited, has secured an exclusive promotion agreement with two subsidiaries of US-based Moksha8 Pharmaceuticals, Moksha8 Brasil Distribuidora e Representação de Medicamentos Ltda. and Moksha8 Farmacéutica, S. de R.L. de C.V. This…
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Zai Lab’s Optune Approved by China’s NMPA, Offering New Hope for Glioblastoma Patients
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Zai Lab Ltd (NASDAQ: ZLAB), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) for its innovative therapeutic device, Optune. This tumor treating fields (TTFields) product is now cleared for use in newly diagnosed glioblastoma in combination with temozolomide, and as a monotherapy…
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Enhancing Clinical Trial Success: CDE’s New Adaptive Design Framework Opens for Comment
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The newly proposed guidelines are designed to be applicable across a spectrum of confirmatory clinical studies, encompassing chemical drugs, biological products, and traditional Chinese medicine (TCM). They also hold significant value for exploratory research endeavors. Adopting an adaptive design should be predicated on considerations of rationality, integrity, and feasibility. The…
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Thermo Fisher Scientific Develops Serology Test to Detect COVID-19 Antibodies in Collaboration with WuXi Diagnostics and Mayo Clinic
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Thermo Fisher Scientific Inc., a titan in the US device industry and listed on the NYSE under the ticker (TMO), has unveiled the development of a serology test designed to detect the SARS-CoV-2 coronavirus. This collaborative effort with China’s WuXi Diagnostics and the prestigious US medical institution, Mayo Clinic, is…
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Cuban-Chinese Pharma Synergy: Joint R&D and Sales Initiative Targets USD 24.53 Billion in Sales
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In a significant move to bolster its innovation pipeline, Guangzhou Pharmaceutical Holdings Ltd. has entered into a letter of intent with BioCubaFarma, Cuba’s leading state-owned pharmaceutical company. This strategic alliance is aimed at joint research and development (R&D), manufacturing, and sales of cutting-edge pharmaceutical products in China, with a particular…
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Guangzhou Pharma and BioCubaFarma Chart New Course with Joint Biologics R&D and Exchange Deal
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Guangzhou Pharmaceutical Holdings Ltd., a prominent player in China’s pharmaceutical sector, has inked a strategic letter of intent with BioCubaFarma, Cuba’s foremost state-owned pharmaceutical juggernaut, to embark on a joint venture in research and development (R&D), manufacturing, and commercialization of avant-garde pharmaceutical products within the Chinese market, with a spotlight…
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Hanx Biopharmaceuticals’ HX009 Receives NMPA Clinical Trial Approval for PD-1/CD47 Bispecific Antibody
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China-based Hanx Biopharmaceuticals Co., Ltd has announced that its self-developed anti PD-1/CD47 bispecific antibody drug, HX009, has received a clinical trial notice from the National Medical Products Administration (NMPA) on October 30, 2019 (Acceptance Number: CXSL1900098). This follows the drug’s ethical review approval in Australia in July, where Phase I…
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LanssonPharm Secures Series A Funding to Accelerate CNS Drug Development
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LanssonPharm, a company dedicated to the development of central nervous system (CNS) drugs, has announced the completion of a Series A funding round worth tens of millions of yuan. The financing was led by Yipu Capital, with follow-on investments from Qianrong Capital and existing shareholder Northern Light Venture Capital. This…
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China’s Ministry of Health Tightens Organ Transplant Regulations with Expert Conference
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Shi Bingyi, a distinguished Member of the National Committee of the CPPCC (Chinese People’s Political Consultative Conference) and Director of the Organ Transplantation Center of the People’s Liberation Army (PLA), has disclosed that China’s Ministry of Health has convened a panel of 70 experts to rigorously assess hospitals involved in…
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China Launches Unprecedented Multi-Center Hypertension Study with Global Implications
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On April 2nd, a landmark healthcare initiative, the “Hypertension Prevention and Treatment Research” project, commenced in Beijing with the backing of China’s Ministry of Health (MOH) and Ministry of Science and Technology (MOST). This ambitious project is structured as a multi-center clinical trial, encompassing 150 clinical centers and engaging 13,000…
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China Biopharma Posts 216% Revenue Increase, Eyes US$10 Million in 2007 with Vaccine Distribution and New Treatments
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China Biopharma Corporation, trading on the OTC Bulletin Board under the symbol (CBPC.OB), announced a remarkable leap in its financial results for 2006 on April 2nd. The company reported a staggering 216% increase in total revenues, surging from US$380,519 in 2005 to US$1.2 million in 2006. This revenue growth was…
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Shanghai to Launch China’s Largest ADR Database, Enhancing Pharmaceutical Oversight
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Shanghai is advancing towards a significant milestone in pharmaceutical safety with plans to establish the largest adverse drug reaction (ADR) database in China. The nascent database has already amassed nearly 300,000 personal drug files and an excess of 10,000 ADR reports, providing a robust foundation for the project. The “Setting…
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China Unveils TCM Development Guidelines: A Strategic Defense of Traditional Medicine
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In a strategic move to assert the value and historical significance of Traditional Chinese Medicine (TCM), China’s Ministry of Health, in conjunction with 15 other government departments, has issued the “Traditional Chinese Medicine Innovation & Development Guidelines from 2006 to 2020” in March. These comprehensive guidelines are seen as a…
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India Launches Anti-Dumping Campaign Against Chinese Vitamin B12 and Ceftriaxone Sodium Producers
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In a strategic response to India’s Ministry of Commerce and Industry’s (MOFCOM) anti-dumping ruling against Chinese vitamin A palmitate producers, Indian pharmaceutical firms have initiated a new campaign on March 13. This time, the focus is on China’s manufacturers of vitamin B12 and ceftriaxone sodium, with customs codes 29362610 and…
