The declaration is bleak! New class 1 chemical drugs may be the highlight of 2016

Source: People's daily, 2016-5-19, at the juncture of new and old policies for drug registration, the relevant policies limited by the new regulations for chemical drug registration were officially published in March 2016, especially the application materials only had a trial draft in May 2016, except for category 1.1 of traditional Chinese medicine, biological agents and chemical drugs (the new category 1 application was not opened) In addition to the normal declaration, the declaration of new 2, 3, 4, 5.1 and 5.2 categories of chemical drugs and their corresponding old classifications has been relatively bleak since this year In addition, in view of the fact that the information related to excipients has not yet been released, the number of approved excipients in China is limited, and it is expected that the application for the recovery of new 2, 3, 4, 5.1 and 5.2 categories of chemical drugs will be resumed as soon as the end of the year Therefore, in 2016, the industry will focus on the declaration of chemical drugs category 1.1 and the declaration of conformity assessment test According to the statistics of the year corresponding to the application acceptance number, since this year (as of May 17, 2016), China has applied for 49 chemicals of category 1.1 In terms of progress, it was over 37% in 2016, but the number of new drugs declared in category 1.1 was only 25% of that in 2015, and the overall declaration data in category 1.1 was lower than that in 2015 As the newly issued application materials for new registration and classification of chemical drugs require that new category 1 of chemical drugs also require to submit electronic documents in CTD format, it is expected that the application of new category 1 chemical drugs will also be affected, and the application of new category 1 chemical drugs in 2016 will hardly exceed that in 2015 Figure: data source of application status of new chemical drugs in category 1.1 from 2010 to 2016: Xianda data v3.2 domestic enterprises began to apply for category 1.1: it is a transformation? Xianda data v3.2 collated the application data of new chemical drugs in category 1.1 from 2010 to now, and Shanghai Xingtai first applied for category 1.1 in 2016 According to the company's website, Shanghai Xingtai, founded in 2006 and located in Zhangjiang High Tech Park, is one of the "4 + 1" R & D platforms of Shanghai Fosun Pharmaceutical Group It is committed to the research of new drug delivery system and drug delivery technology, the development and verification of pharmaceutical chemistry and analytical methods, the research and development of CMC for innovative drugs and generic drugs, as well as domestic and international registration and other businesses In 2013, Shanghai Xingtai's new drug research and development direction was mainly "sustained and controlled release preparations" In 2012, it applied for 5 new drugs nisoldipine sustained-release tablets (Ⅱ), in 2015, it applied for 5 classes of memantine hydrochloride sustained-release capsules and 3.1 classes of enzalutamide soft capsules In 2016, Shanghai Xingtai and Shanghai Fosun Pharmaceutical Industry Development Co., Ltd jointly applied for category 1.1 PA-824 and tablets after the new registration regulations for chemical drugs were issued Xi'an Libang Pharmaceutical Co., Ltd is also the first manufacturer applying for chemical medicine 1.1 in recent six years This product line mainly focuses on surgical anesthesia and clinical nutrition The new drugs 1.1 applied for are isopropylbisphenol and isopropylbisphenol injection, which belong to surgical anesthesia Comments: the application case of Shanghai Xingtai may be considered as a kind of "stress reaction" of the enterprise after the registration requirements of the new class 2 chemical medicine improved type have come out, that is, the application of class 1 new medicine has been changed On the other hand, some domestic enterprises that have never applied for a new class 1 drug, from applying for generic drugs to applying for a new class 1 drug, are more like a breakthrough from "quantitative change" to "qualitative change" after quietly accumulating application experience Enterprises supported by foreign capital: Shanghai Yingpai Pharmaceutical Co., Ltd., initiated by Nanjing Yingpai Pharmaceutical Co., Ltd of new drug category 1.1, applied for imp4297 and capsule category 1.1 in 2016 Nanjing Yingpai and Shanghai Yingpai have not declared products in China before Nanjing Yingpai was registered and established in June 2009 It is committed to the research and development of best in class new drugs with independent intellectual property rights for the treatment of cancer and other diseases, and commercialization of them In July 2014, the first round of financing was successfully completed The funds are from Lilai Asia Investment Fund, Qianji venture capital fund, Wuxi Wuxi Wuxi yaomingkant phase I investment fund Betaporma (Shanghai) Co., Ltd., a wholly-owned enterprise invested by betaporma company of the United States in Shanghai, has applied for the first class of new drug bpi-7711 and capsule in China The business scope of Beida pharmaceutical development (Shanghai) is the research of new anticancer drugs, biological drugs and pharmaceutical intermediates, the transfer of its own technology and related technical consultation (those involving licensed operation shall be operated with license) It is estimated that bpi-7711 and capsules are anticancer drugs Kangnaide biomedical (Shanghai) Co., Ltd is also the first enterprise applying for class 1 new drugs this year The products applied for are cbp-307 and its capsules Kangnaide biomedical (Shanghai) Co., Ltd is mainly initiated by Suzhou kangnaide biomedical Co., Ltd and Suzhou kangnaide is a joint venture limited liability company between Taiwan, Hong Kong and Macao, with its shareholders including Hong Kong kangnaide biomedical Co., Ltd Comments: the number of overseas invested technology companies applying for new drugs of category 1.1 in China has increased, which represents that overseas capital is optimistic about China's pharmaceutical market The positive factors also include that the recently issued domestic new drug registration laws and regulations are good for more standardized projects and guide the projects with better quality to be listed in China In addition, the system of listing licensors also gives science and technology companies new opportunities to grow and encourage them to develop new drugs with a longer exclusive period Summary: the clinical application of class 1.1 new drugs is only the early stage of the project, and there is still a long way to go until the application for production and then to the application for listing It is worth noting that Jiangsu Hengrui, Jiangsu Haosen, Guangdong Dongguang, Shandong xuanzhu pharmaceutical technology, Baiji Shenzhou, Sinopharm and Shandong Henri have applied for 1.1 new drugs for three consecutive years In 2016, the new regulations suddenly fell silent Some enterprises are ready to layout at the same time at home and abroad Some enterprises need to re-examine the projects approved before deciding whether to move forward In 2016, it is the year that pharmaceutical enterprises rearrange according to policies.