Domestic oral new crown prevention and treatment drugs welcome progress again, and
the homogenization of innovative drug research and development is still serious
Following Xinhua Pharmaceuticals, Henan Real Biotechnology Co., Ltd. (hereinafter referred to as "Real Bio") has finalized another production and distributor of the oral new crown prevention and control drug Azvudine.
On May 8, China Resources Shuanghe (600062) announced that the company signed the "Strategic Cooperation Agreement" and "Azvudine Tablets Entrusted Processing and Production Framework Agreement" with Real Biology, and will be entrusted with the processing and production of Azvudine tablets.
Affected by this news, on May 9, China Resources Shuanghe opened the daily limit; in foreign countries, recently, Remdesivir was authorized by the FDA to expand the scope of treatment to people under the age of 12, and was conditionally recommended by the WHO (World Health Organization). It is used to treat non-severe COVID-19 patients with a high risk of hospitalization. At the same time, Gilead is also accelerating the development of an oral version of remdesivir.
On the one hand, the research and development of innovative drugs at home and abroad is in full swing recently.
Text/Photo Guangzhou Daily
All media reporter Tu Duanyu
Many pharmaceutical companies deploy new crown prevention and treatment drug track
It is reported that after the outbreak of the new crown pneumonia, Real Bio has started clinical research on azvudine in the treatment of new coronary pneumonia. Not long ago, the website of the National Center for Drug Evaluation showed that Real Bio submitted an application for a Class III communication meeting, and the status column was changed from "Processing" Medium" was changed to "Feedbacked".
This change is believed by industry insiders that the Phase III clinical trial of Azvudine is about to be unblinded and declared for marketing, and it is expected to become the first domestically-made oral drug for the prevention and treatment of the new crown.
The novel coronavirus antiviral small molecule oral drug has become one of the most highly anticipated treatments in the epidemic because of its advantages of rapid mass production, high accessibility, and high cost performance.
At present, two oral new crown prevention and treatment drugs have been approved for marketing in the world, which are Molnupiravir of Merck and Pfizer's Paxlovid. No domestically developed oral new crown prevention and treatment drugs have been approved.
At present, there are more than 10 domestic small molecule new crown oral drugs in urgent research and development, and a number of domestic oral new crown prevention and treatment drugs have entered the third phase of clinical trials.
A number of relevant drug R&D personnel have stated that there are no technical difficulties in the research and development of oral new crown prevention and treatment drugs, and the product may be launched within this year.
Since 2022, there has been an intensive release of good news about domestically produced oral new crown prevention and treatment drugs, and more pharmaceutical companies are achieving technological breakthroughs and lining up to enter the clinical stage.
There are many domestic companies deploying oral new crown prevention and control drugs. In addition to Kintor Pharmaceuticals, Junshi Bio/Wangshan Wangshui, and Real Biology, which are the first to enter the third phase of clinical trials, there are also Simcere Pharmaceuticals, Guangshengtang Pharmaceuticals, Geography, etc. Li Pharmaceutical, Genting New Drug, Luye Pharmaceutical, Fuhong Henlius, China Cell and many other biological enterprises.
At the same time, as the original researcher of Remdesivir, Gilead also started the research and development of the oral version of Remdesivir.
Currently, Gilead is developing a remdesivir prodrug called GS-5245, which can be rapidly converted into remdesivir in the body.
Gilead’s website shows that GS-5245 is in Phase I clinical stage.
Industry: The pace of innovative drug research and development is accelerating, but there are many problems
Recently, a number of pharmaceutical companies are actively promoting innovative drug projects. Jingxin Pharmaceutical's Class 1 new drug Adacini Capsules has been reported for production, becoming the company's first small molecule innovative drug to apply for listing. A number of innovative drug projects such as Jiaxing and Jiaxing have been approved for clinical use for the first time.
In terms of clinical progress, Kelun Pharmaceutical's new Trop2 ADC drug SKB264 and Frontier Bio's new crown small molecule drug FB2001 will also start clinical registration.
Although my country's innovative drug research and development has accelerated, the industry believes that there are still many existing problems.
Du Xiangyang, chief analyst of the pharmaceutical industry at Southwest Securities, once pointed out that innovative pharmaceutical companies are currently facing three major challenges: for example, basic research is relatively weak, and there is still room for improvement in the number of top life science and medical research institutions; China's innovative research focuses on following hot frontiers. Mainly, basic research still faces many shortcomings; China's drug R&D is seriously homogenized. Taking PD-1 as an example, the domestic competition for innovative drug target research is fierce. At present, there are still a large number of PD-1 products in the clinical stage. Biopharmaceutical companies are still following research on overseas targets.
The industry's view is that with the acceleration of the research and development of innovative drugs, especially the homogenization of similar targets, the entire life cycle of innovative drugs will be further shortened.
Overseas innovative drugs have patent dividends and can basically achieve exclusive sales for more than ten years.
Domestic homogenization research, including accelerated market access, and domestic fast-following strategies will further shorten the life cycle of innovative drugs, which will also have some impact on the commercialization of innovative drugs, which is also a major challenge for innovative drugs.