The third batch of clinical urgent need for overseas new drug list public! The "heavy bomb" is in the column

Medicine Network October 30th October 29th, CDE announced the third batch of clinically urgent overseas new drugs, including Danish drugmaker Aablynx's nanoantibody drug Cablivi and Astellas' FLT3 inhibitor Xos Pata, the U.S. pharmaceutical company Agios leukemia drug Tibsovo and other 7 domestic unlisted and clinically urgently needed special effects drugs, treatment in the field of blood system diseases, malignant blood diseases, genetic metabolic diseases, nervous system, infectious diseases and eye diseases.
Three drugs have been submitted for listing in China in October 2018, the State Drug Administration, in cooperation with the National Health and Wellness Commission, has drafted the "Clinically Urgent Need for Overseas New Drug Review and Approval Procedure" to establish a special channel to speed up the review and approval of new drugs that are clinically urgently needed overseas.
It is learned that the overseas list of clinically urgently needed new drugs is mainly in recent years the United States, the European Union or Japan approved the listing of China has not yet listed, for rare diseases treatment of new drugs, as well as for the prevention and treatment of serious life-threatening or seriously affected quality of life of diseases, and there is no effective treatment or has a clear clinical advantage of new drugs.
CDE released two batches of clinically urgent overseas new drugs in November 2018 and May 2019, involving a total of 66 drugs.
According to statistics, as of October 2020, 37 new overseas drugs, including Amgen's Deshu monoantigen injection, Merca East's Pablo Pearl single anti-injection and Pfizer's chlorpyriric acid softgels, have been approved for sale in China, and the urgent need for patients to use the drug has been further alleviated.
the third batch of clinically urgent overseas new drugs, three of which have been submitted for listing in China.
April this year, Astellas announced that NMPA had accepted AMO's daily application for a new drug for oral therapy (NDA) for the treatment of recurring or refractic (therapeutic resistance) acute myeloid leukemia (AML) adult patients with FLT3 mutation-positive (FLT3mut plus).
Xospata has also been formally included in the priority review, and the industry expects the drug to be approved for sale in the second quarter of 2021.
2019 generated $136 million (14.3 billion yen) in sales for Astellas, according to public information released by the company.
addition, Yan Jian's new drug for multiple sclerosis, Tecfidera, filed a domestic listing application in February.
in 2019, Yan Jian achieved sales of $4.4 billion with this heavy-weight small molecule drug.
, Tecfidera has entered the first round of additional information and is expected to be approved in the first quarter of 2021.
is worth noting that eight local pharmaceutical companies, such as Jiangxi Qingfeng Pharmaceuticals, Shanghai Huilun Jiangsu Pharmaceuticals and Lili Pharmaceuticals, have also begun to lay out the variety.
third drug already declared on the domestic market is the super-flu-resistant new drug Xofluza.
Xofluza was developed by Shionogi, a Japanese drug company, with which Roche signed a partnership agreement in 2016 to jointly develop the drug outside Japan and Taiwan, where Roche has commercial promotion rights outside Japan and Taiwan.
is the first anti-flu drug approved in the U.S. in nearly 20 years, and Xofluza contributed $234 million to Roche in 2019 thanks to a new anti-flu mechanism.
The international industry ecological change in the direction of research and development in the industry, in recent years, the reform of drug policy has greatly accelerated the speed of foreign new drugs into the Chinese market, in the benefit of domestic patients, but also let China's new drug research and development environment has undergone great changes.
Some analysts pointed out that generic drug consistency evaluation is promoting the internationalization of generic drug quality in China, NMPA to join ICH is to achieve the internationalization of the regulatory system, regulatory authorities encourage the development of international multi-center clinical trials (MRCT) reflects the internationalization of innovative drug research and development, and the accelerated entry of imported drugs into China's market shows that the domestic pharmaceutical market is going international, the international industrial ecology of domestic pharmaceutical enterprises put forward new requirements and challenges.
" requires local pharmaceutical companies to develop new drugs from China to the global new, from the Chinese market to the global market.
", but it should not be overlooked that the development of new drugs such as PD-1/PD-L1, BTK inhibitors and other popular targets has been caught in homogenization of the competition in the Red Sea.
Faced with the difficulties of innovative drug research and development in local pharmaceutical companies, some pharmaceutical companies research and development executives pointed out that the solution must undoubtedly start from improving the innovation of new drug research and development, improve the efficiency and speed of new drug research and development, and accelerate the pace of internationalization and other dimensions.
" in the domestic first innovative drug is still facing greater difficulties, because the research and development foundation of pharmaceutical companies is not solid, there are still many thresholds, but still to firmly the goal in that direction.
Of course, the higher the innovation of the drug also means that the greater the risk of failure in research and development, and the success rate of different kinds of drugs such as biopharmaceus larger molecules and small chemical molecules themselves is very different, which requires in-depth research by pharmaceutical companies.
is also a breakthrough in how to differentiate drugs with existing targets, including new adaptive development and drug combination innovation.
In addition, how to improve efficiency and speed and form an efficient research and development system by optimizing the process, adopting new technology, establishing key technology platform, strengthening transformation research and other means, under the premise of ensuring drug quality, is also an important part of the research and development process of new drugs.
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