Medical and health industry weekly (November 4-8)

Jointly released by: Sina pharmaceutical, CCID Consultant This week, a total of 6 drafts were released, including guiding principles for drafting pharmacovigilance entrustment agreement (Draft for comments), principles and procedures for drug sampling (Draft for comments), guiding principles for technical review of registration of instructions for household medical devices (Draft for comments), evaluation of consistency of quality and efficacy of generic drugs (special injections) for chemical injections Technical requirements (Draft for comments), guidelines for technical review of 3D printing spine fusion device product registration (Draft for comments), and guidelines for technical review of hemodialysis equipment registration (Draft for comments) As they are all draft for comments, this week's focus policy is not listed Table 1 list of policies and regulations issued from November 4 to November 8 There are 144 drug registration applications this week According to the drug category, the number of chemical drug registration applications is the largest, 116 cases, accounting for 81%; the number of biological products and traditional Chinese medicine registration applications accounts for 11% and 8%, respectively According to the classification of registration application types, 80 cases are supplementary applications, accounting for 56%; generic drugs, accounting for 15%; new drugs, accounting for 17%; imported drugs, accounting for 7% 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, Jiangsu Hengrui Pharmaceutical Co., Ltd., which received the largest number of registered drugs, received up to 10 cases Figure 3 the number of drug registrations declared by enterprises in China this week top 10 In terms of consistency evaluation, 13 application numbers have been undertaken this week, mainly involving 12 drug categories, such as Avastin capsule, amoxicillin capsule, azathioprine tablet, potassium chloride injection, losartan potassium hydrochlorothiazide tablet, Difenidol hydrochloride tablet, lidocaine hydrochloride injection, berberine hydrochloride tablet, omeprazole sodium for injection, daptomycin for injection, ceftazidime for injection, etc No, two enterprises, Qing Yutang Pharmaceutical Co., Ltd of Fu'an Pharmaceutical Group and Sichuan Emei Mountain Pharmaceutical Co., Ltd., have received a lot of conformity assessment drugs, each of which is 2 cases Table 2 Application No of conformity assessment from November 4 to November 8 This week, there are 5 newly reviewed consistency evaluation cases, namely, clozapine tablets of Jiangsu Enhua Pharmaceutical Co., Ltd (acceptance No.: cyhb1850357), Nateglinide tablets of Jiangsu Deyuan Pharmaceutical Co., Ltd (acceptance No.: cyhb1850322), Loratadine Tablets of Xi'an YANGSEN Pharmaceutical Co., Ltd (acceptance No.: cyhb1840099), Yichang dongyangguang Changjiang Pharmaceutical Co., Ltd Fuduositan tablets (acceptance No.: cyhb1850213) and calcium dobesilate capsules (acceptance No.: cyhb1850195) of Ningxia Kangya Pharmaceutical Co., Ltd At present, 5 categories have been approved and are waiting for certification In terms of the investment and financing market in the mainland, there were 5 investment and financing events in the field of medicine and health this week, including 2 cases where the specific data were not disclosed and the specific amount was disclosed The investment targets are Peijia medical, Bo Bang Fangzhou, heding medical, Yikang gene and nuoxin joint venture, mainly involving high-end plant intervention equipment, precision medical and AI medical fields Table 3 mainland investment and financing events from November 4 to November 8 Among them, Peijia Medical Technology Co., Ltd was founded in 2012 and completed the strategic integration with the neuro intervention company, gage bio in 2018 This integration has strengthened the synergistic effect in R & D, clinical, quality control, operation and promotion The company's independently developed heart valve and nerve intervention products are located in the track, which is also the fastest growing field of medical devices with huge potential market scale Bo Bang Fangzhou is a medical device company integrating R & D, production and sales, Focus on the detection of noninvasive physiological parameters of human body, It is committed to building a chronic disease management system based on self-developed hardware platform; heding pharmaceutical has the world's top research and management team in the United States, the leading level of research and development, and provides customized service for research and development of APIs as well as R & D and production amplification of its own products for global pharmaceutical enterprises and chemical synthesis technology companies; Yikang gene was founded in 2012, It is dedicated to the development and application of single cell whole genome amplification and sequencing technology, It is a high-tech enterprise that provides precise medical detection technology for the fields of eugenics and early diagnosis of tumor Nexin Chuanglian is a life science marketing solution company based on AI technology The marketing product service system integrates the medical data of various regions with advanced technologies and algorithms such as NLP, big data analysis and convolution neural network, forming a doctor centered, radiation medicine, diagnosis and treatment The medical data knowledge map of materials, operations and other aspects helps medical enterprises achieve higher efficiency coverage, achieve more efficient transfer of professional information between new drugs and core doctors, and help grassroots doctors more efficiently acquire the same professional knowledge as core doctors In terms of overseas investment and financing market, this week three major investment and financing events were monitored in the field of medical health, with the investment targets of pathai, shape therapeutics and scanwell health The investment event mainly involves the fields of AI medical treatment and gene editing Table 4 overseas investment and financing events from November 4 to November 8