Medical and health industry weekly (December 2-6)

Content joint release: CCID consultant, Sina pharmaceutical Data source: brain of CCID medical and health industry Six policies and regulations were issued this week, among which the notice on strengthening the performance appraisal of secondary public hospitals was the key policy of this week, which was officially released by the general office of the National Health Commission on December 5 Table 1 list of policies and regulations issued from December 2 to 6 On January 30 this year, the opinions of the general office of the State Council on strengthening the performance appraisal of three-level public hospitals was released, and the performance appraisal of three-level public hospitals was launched On the basis of summing up the work experience of performance appraisal of the third level public hospitals, the notice on strengthening the performance appraisal of the second level public hospitals (hereinafter referred to as the notice) was issued on December 5, which made it clear that the performance appraisal of the second level public hospitals would be launched in 2020 The performance evaluation index system of the secondary public hospital consists of four indicators: medical quality, operation efficiency, sustainable development and satisfaction evaluation According to the notice, the performance evaluation index system of the second level public hospital and the third level public hospital also includes four aspects: medical quality, operation efficiency, sustainable development and satisfaction evaluation The difference is that there are 28 indicators in the performance evaluation index system of secondary public hospitals, and all 28 indicators are quantitative indicators Among the 28 quantitative indicators, 13 are medical quality indicators, 9 are operational efficiency indicators, 4 are sustainable development indicators, and 2 are satisfaction evaluation indicators, among which 21 are national detection indicators According to the notice, the performance appraisal of secondary public hospitals is carried out in accordance with the year, and the appraisal data node is from January 1 to December 31 of the year The performance appraisal of the second level public hospital and the third level public hospital is also divided into three procedures: self-examination and self-evaluation of the hospital, annual evaluation at the provincial level, and national monitoring and analysis However, in the specific implementation, the performance appraisal of the second level public hospital needs to be evaluated, monitored and analyzed in combination with the actual situation of each province The notice made it clear that on the basis of the continuation of the three-level public hospital performance evaluation index system framework, according to the actual situation of the two-level public hospitals, the performance evaluation index system of the two-level public hospitals was formed in accordance with the principle of "collection first, filling in second" A total of 151 drug registration applications (excluding reexamination) were accepted this week According to the drug category, the number of chemical drug registration applications was the largest, with 115 cases accounting for 76%; the number of biological products and traditional Chinese medicine registration applications accounted for 13% and 11%, respectively According to the classification of registration application types, 99 cases are supplementary applications, accounting for 66%; the acceptance of generic drugs accounts for 14%; the acceptance of new drugs accounts for 12%; the acceptance of imported drugs accounts for 16%; and the acceptance of import re registration accounts for 8% Figure 1 drug categories accepted for registration and declaration in China this week Figure 2 types of drug registration and declaration accepted nationwide this week This week, Mengdi (China) Pharmaceutical Co., Ltd received the largest number of registered drugs, with 6 cases accepted, followed by Pfizer Investment Co., Ltd., with 5 cases accepted and 4 cases accepted by three enterprises Figure 3 the number of drug registrations declared by enterprises in China this week top 10 In terms of consistency evaluation, there are 21 application numbers in this week, mainly involving 17 drug categories such as glycerin fructose sodium chloride injection, nabufine hydrochloride injection, lidocaine hydrochloride injection, clozapine tablets, amiodarone hydrochloride tablets, compound sodium chloride injection, among which the application number of ambroxol hydrochloride injection of Hebei aierhaitai Pharmaceutical Co., Ltd reaches 3, The consistency evaluation application number of ropinirol hydrochloride tablets of Chongqing Zhien Pharmaceutical Co., Ltd reached 2 cases Table 2 list of conformity assessment application No from December 2 to December 6 In terms of the investment and financing market in the mainland, there were 7 investment and financing events in the field of medical health this week, including 2 events that disclosed a clear amount, with a total amount of 303 million yuan The investment targets are Hezuo biology, Ruibo biology, rice and millet, Yunshi software, Yujian happiness, mainly involving medical devices, genetic engineering, small nucleic acid drugs, rehabilitation and other fields In terms of the disclosed amount, the amount of UBS bio financing is the highest, reaching 203 million yuan Table 4 mainland investment and financing events from December 2 to 6 On December 2, Huida gene announced that it had completed round a financing of more than RMB 100 million, led by Chende capital, followed by four institutions, namely, new investment fangmingkant, Huiyi capital, Yahui capital and original investor Sherpa investment The financing income of this round will be mainly used for the promotion of the core clinical pipeline of Huida gene, the establishment of R & D and pre clinical research team and the construction of GMP level production workshop Founded on October 31, 2018, Huida gene is registered in Shanghai Pudong International Medical Park The company is committed to the research and development of new treatment technologies and drugs for human rare genetic diseases Now it has built a 500 square meter gene therapy research and development laboratory (BSL-2), which is a new cutting-edge enterprise in gene editing and gene therapy, covering gene editing technology platform, AAV technology platform, disease model animal The platform and process transformation and production platform are committed to becoming the best gene therapy platform in China and the world In the global environment of full competition in gene editing technology, vector screening and other fields, Huida gene is at the forefront of the industry In clinical transformation, Huida gene has a strong editing and treatment strategy, vector design and human-based animal model verification ability, while the back-end GMP level production process has made great progress in the past year This composite ability is very scarce Huida The future of genes is promising The main clinical indications selected by Huida gene are rare genetic diseases with single gene mutation, which involve neurodegenerative diseases, visual disorders and hearing disorders In the world, Zhang Feng, the leader of gene editing technology, and others have established a number of gene therapy companies, several of which have completed listing, and relevant gene editing therapy has also started clinical trials In contrast, gene therapy in China is almost blank How to get through the industrial chain is the first job to eat crabs in China At present, Huida gene does not emphasize the number of clinical pipelines, but focuses on the R & D and production mode of the whole pipeline to promote the maturity of several major technical platforms In terms of overseas investment and financing market, there were 7 major investment and financing events in the field of medical health this week, with a total financing amount of about 2.71 billion yuan The investment targets are black diamond therapeutics, limelight Bi, suvoda, diabeloop, venclose, impulse dynamics, close biopharmaceuticals, mainly involving cancer drug research and development, biotechnology, medical devices and other fields Among them, black diamond therapeutics obtained US $85 million in financing, with the highest amount Table 5 overseas investment and financing events from December 2 to 6