Close Icon
We use cookies to improve your website experience. To learn about our use of cookies and how you can manage your cookie settings, please see our Cookie Policy. By continuing to use the website, you consent to our use of cookies.
Pharma Intelligence is part of the Informa Intelligence Division of Informa PLC
This is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.
Authorities in China are tightening their oversight over suspected coronavirus cases, allowing hospitals to quarantine suspected patients upon their first visit, as one domestic pharma firm rushes to develop potential drug treatments for the spreading outbreak.
The National Health Commission issued rules allowing medical facilities this power, even if symptoms are mild. The patients must be under 65 years old, self-sustaining and without respiratory, cardiovascular or other chronic conditions and psychiatric disorders and outside visits will not be allowed. The new measures do not define the length of quarantine.
Meanwhile, China’s ruling party leadership has gathered again since the outbreak and required centralized oversight over containment efforts. One of the measures approved was to centralize the quarantine of all patients with severe symptoms. Wuhan, the epicenter of the outbreak, has been building two dedicated hospitals, with one, Huoshengshan Hospital, already completed over 10 days and put into use on 3 February.
Beijing is also rebuilding a dedicated facility, Xiaotangshan hospital, in the Changping district, whichScrip recently visited and found construction underway around the clock. Hundreds of workers from Beijing and surrounding Hebei province are working on the site, which one observer said seemed around half complete.
An IND for the local study with remdesivir, which has not been approved anywhere, has now been approved by China's regulator, the NMPA, and will be conducted at the Wuhan Sino-Japan Friendship Hospital. But the trial is expected to run months before results, cautioned experts.
In the interim, domestic antiviral-focused firm Ascletis Pharma Inc. said on 25 January it had filed an emergency approval application for its generic version of ritonavir and a combination of ritonavir and the protease inhibitor ASC09 with the NMPA’s Center for Disease Evolution.
Hangzhou-based Ascletis had filed for the approval of ritonavir last August as a generic version of originator AbbVie Inc.’s Norvir. So far, only AbbVie's Kaletra (lopinavir and ritonavir) has been formally recommended as an antiviral against the new coronavirus.
Device Makers Get Approvals
A number of domestic firms producing medical devices to treat virus-caused respiratory syndrome have also scored expedited approvals. In Hunan, the neighboring province to Hubei where Wuhan is the capital, regulators approved a major design change to an assisted respiration machine filed by Hunan Mingkang Zhongjin Medical Technology Co., which supplies Wuhan hospitals.
Guangdong provincial regulators granted green lights to a sealed hospital bed and surgical suit, both filed and approved under an emergency use pathway, while Jiangsu approved an isolation capsule used to transfer affected patients.
National Health Commission data show that by 3 February confirmed cases reached 20,438, including 2,788 severe cases. Hubei province remains the hardest hit, with 2,345 new cases and 64 deaths, out of 425 nationwide.
Outside China, there are some encouraging signs that newly confirmed cases have stabilized.
Whether you’re a small biotech start-up, research firm, generic manufacturer or a global pharmaceutical giant, you need focused, independent insight and opinion on market developments.
Support the development and validation of your strategic plans and ensure commercial decisions are based on marketplace realities. Datamonitor Healthcare offers expert coverage of key diseases, treatments, companies, drugs, market access and market trends.Results from in-depth KOL and payer interviews and physician surveys provide a current understanding of patient segmentation, influences and preferences, prescribing trends, unmet needs, and more
Trialtrove: gold standard clinical trials intelligence
Trialtrove is the go-to resource for clinical trial research. Easily track your competitors' clinical R&D activity with expert insights and continually monitored trials.
Biomedtracker: see the drug development process through analysts’ eyes
Biomedtracker provides real-time analysis of major market-moving events in the pharma and biotech industries. With catalyst tracking and expert insights, Biomedtracker helps you stay on top of breaking events, the drugs pipeline, upcoming milestones, companies, and deals – and their impact on the markets you care about.
Request a Trial
Pharma Report Store
