The API of GlaxoSmithKline's HIV therapy Tivicay (dolutegravir) will be made in China by Shanghai-based Desano Pharmaceuticals under a deal with the British drug maker's ViiV Healthcare arm, according to a press release.
Hypertension afflicted 25.2% of China's adult population and diabetes 9.7%, according to the state-run Xinhua news agency. That's according to a survey conducted by the National Health and Family Planning Commission over a decade that jibes with other recent public policy healthcare reform efforts by the State Council.
China-based Ascletis Pharmaceuticals has notched up a first with plans for Phase III trials of danoprevir (ASC08) and ASC16 (PPI-668) to treat chronic hepatitis C in China and Taiwan. If successful, the trials could represent a milestone that could reach an estimated patient population of 30 million to 40 million, the highest worldwide.
China's hit-and-miss government oversight poses special challenges for drug regulators who too often find companies there skirting the standards they expect. For the second time this year, European regulators have put a halt on exports from a Chinese company that they discovered had serious problems.
The FDA once again pitched in last week with other international regulators to crack down on illegal and counterfeit drugs being peddled over the internet. The FDA, Interpol and other authorities seized drugs, shut down some websites and made some arrests.
China's Zhuhai United Laboratories bills itself as the world's largest manufacturer of the API for the antibiotic amoxicillin. But the sterile manufacturing for some of its amoxicillin products has been called into question by inspectors in Europe, which is banning the sterile drugs for now, except in limited cases.
Recently listed in Hong Kong 3SBio said it has bought the ex-China rights to Apexigen's anti-TNF monoclonal antibody technology, adding to mainland rights held since 2006.
China's BeiGene has received U.S. FDA approval on an IND application for clinical development of BGB-3111, a proprietary Bruton tyrosine kinase inhibitor for the treatment of B-cell malignancies, putting a fresh round of funds to use as it works on three main oncology candidates.
A steady march of investments in U.S. high-technology sectors by Chinese companies from telecom to biotech will come into focus this week in high-level talks in Washington, DC, that will cover a proposed bilateral investment treaty, Reuters reports.
China's Pearl River flows with residues of three dozen types of common antibiotics widely consumed by top-user China, a Chinese Academy of Sciences-sponsored study found. The study suggests that overuse by humans and animals is the main driver causing densely populated areas to see high concentrations of antibiotic residue.