Simplified Chinese
26
2017-09
The FDA recommends approving a new HBV vaccine for adults.
The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee voted 12 to 1 to recommend approval of a new hepatitis B vaccine for the prevention of hepatitis B. Dr. Jay M. Portnoy of Children’s Mercy Hospital in Kansas City, Missouri, noted, “The vaccine’s safety and efficacy data are reassuring.” Hepatitis B is a global epidemic with widespread impact. Currently, approximately 240 million people worldwide are chronically infected with HBV, and each year about 650,000 individuals die from liver failure, cirrhosis, and hepatocellular carcinoma (HCC) caused by HBV infection.
26
2017-09
Pharmaceutical giants’ mergers and acquisitions are reshaping the domestic vaccine market.
Recently, the renowned pharmaceutical market research firm EvaluatePharma released its report “World Preview 2017: Outlook to 2022,” offering a forecast for the pharmaceutical industry from 2017 to 2022. According to the report’s projections, in the global vaccine market, the four major players—GSK, Merck, Pfizer, and Sanofi—will continue to lead, each capturing roughly 20% of the market share. Their combined sales are expected to reach $5.568 billion, with the market share projected to decline slightly to 19.3% by 2022, while total sales are anticipated to rise to $6.826 billion.
26
2017-09
At the invitation of Cuba’s Biotechnology and Pharmaceutical Group (BioCubaFarma), Du Weimin, Chairman of Kangtai Biological; Zheng Haifa, Deputy General Manager; and Zhang Qian, Head of International Cooperation, attended the Ninth Closed‑Door Meeting of the China–Cuba Joint Working Group on Biotechnology, held in Guangzhou on July 3–4, 2017. Participants included representatives from Cuba’s Biotechnology and Pharmaceutical Group, the Cuban Center for Genetic Engineering and Biotechnology, the Cuban Center for Molecular Immunology, the Cuban Institute of Ophthalmology and the National Center for Scientific Research, as well as the Cuban Embassy in China, the Cuban National Center for Medicines and Medical Devices, and China’s National Development and Reform Commission and Ministry of Foreign Affairs.
26
2017-09
The abolition of GMP certification has finally been finalized.
According to sources, at the recently concluded National Symposium on Food and Drug Supervision, Deputy Director Wu Zhen delivered a speech reviewing drug regulation in the first half of 2017 and outlining new requirements and approaches for the second half of the year. In terms of regulatory strategy, the focus will be on core responsibilities, rigorous oversight, and accountability. The provincial drug regulatory authorities are urged to shift away from an overemphasis on approvals at the expense of supervision, strengthening inspection and enforcement while reducing reliance on licensing and approval processes. This implies that many regulators will need to pivot their priorities toward frontline inspections. Going forward, GMP, GCP, GLP, and GSP certifications are slated for abolition.
10
2017-08
I. Project Name: R&D and Production Building (R&D and Production Building Construction Project) II. Project Overview: This project is located at No. 35 Simiao Road, Biomedical Industry Base, Daxing District, Beijing. The building measures 112.9 m in length and 54.7 m in width, with one basement level and a total floor area of 6,299.39 m². Above ground, there are three floors totaling 21,042.12 m², for a combined gross floor area of 27,341.51 m². The basement has a floor-to-floor height of 5.2 m, the above-ground floors are 7.6 m high, and the mezzanine level stands at 3.8 m. The overall building height is 24 m. The structure is a reinforced concrete frame system. III. Scope of Tender: The scope of this tender covers the R&D and Production Building (R&D and Production Building Construction).