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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…
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Novartis Sees 15% Global Sales Growth and Significant Investment in China for 2006
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Novartis (NYSE: NVS), a multinational pharmaceutical giant, has reported a robust sales revenue of nearly US$275.7 million in the China market for the year 2006. This figure comes as part of a broader global sales increase of 15%, propelling the company’s total global revenue to US$37 billion, with net income…
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Ruijin Hospital Researchers Uncover Five New Mutations in Rare 17OHD Endocrine Disorder
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In a significant advancement in endocrine research, scientists within the Endocrine Department at Ruijin Hospital have identified five novel mutations through clinical and genetic examinations of eight patients diagnosed with 17 alpha-Hydroxylase/17,20 Lyase Deficiency (17OHD). The most prevalent genotype observed was D487-F489del. Structural protein analysis and in vitro studies have…
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China’s SFDA Mandates Official Position Rotation to Boost Transparency
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China’s State Food and Drug Administration (SFDA) is poised to embrace a new era of transparency with the announcement of its forthcoming measures by Shao Mingli, the agency’s head. Scheduled for the second half of 2007, the SFDA is preparing to initiate regular press conferences, a proactive step designed to…
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Guangdong’s ‘Sunlight Purchase’ System Sparks Drug Pricing War and Uncovers Pricing Anomalies
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Since 2007, Guangdong province’s medical facilities have utilized an online procurement system known as “Sunlight Purchase” for drug acquisitions. However, this system has inadvertently ignited an unprecedented pricing war, simultaneously exposing deep-rooted issues within drug pricing structures. A pivotal conference convened on March 31 by the Guangdong Drug Purchase Service…
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Ruijin Hospital Unveils Five New Mutations in Rare Adrenal Hyperplasia Study
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In a groundbreaking study, Ruijin Hospital’s Endocrine Department researchers identified five novel mutations in 17 alpha-Hydroxylase/17,20 Lyase Deficiency (17OHD), a rare inherited adrenal hyperplasia. The research, spanning three years and encompassing eight patients from seven families, unveiled six mutations within the CYP17A1 gene, with five being previously unreported. The D487-F489del…
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SFDA Embraces Transparency: Regular Press Briefings and Personnel Rotations Announced
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China’s State Food and Drug Administration (SFDA) is gearing up for a transparency overhaul, with its head, Shao Mingli, unveiling a slate of reforms aimed at bolstering public and media scrutiny. Scheduled for the latter half of 2007, the agency will initiate a series of regular press conferences, marking a…
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China’s Western Pharmaceutical Exports Soar 23% in 2006, Led by Antibiotics
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The China Chamber of Commerce for Import and Export of Medicines and Health Products (CCCMHPIE) has reported a robust surge in China’s export values for Western pharmaceutical preparations in 2006. The year-on-year growth rate reached a significant 23%, with the total value amassing to US$504 million. Among the various categories,…
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Shanghai Roche Pharmaceuticals Launches Erlotinib for Advanced Non-Small Cell Lung Cancer in China
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Shanghai Roche Pharmaceuticals Ltd. made headlines in March with the launch of its lung cancer treatment, Erlotinib, in the Chinese market. This targeted therapy is designed for patients with advanced non-small cell lung cancer (NSCLC) that has continued to progress despite standard chemotherapy. Erlotinib’s mechanism of action involves the specific…
