Joint Release: Sina Pharmaceuticals, Saidi Consultants Week Overview: Policy and Regulation, this week released three policy documents, respectively, the National Health Commission Of the State Administration of Market Supervision and Administration on the release of "Food Safety National Standard Food Flavors" (GB 30616-2 020) and other 38 national standards for food safety and 4 amendments to the list of announcements, the State Drug Administration on the key varieties of information tracing system construction work (No. 111 of 2020) and food safety national standards review committee secretariat on Letter requesting opinions on 18 national food safety standards (drafts for comments), such as glue-based and its ingredients; Medical and health industry this week inventory, wonderful continue! First, the policy direction mark this week there are 3 cases of policy release, respectively, the State Health Commission Of the State Administration of Market Supervision and Administration on the release of "food safety national standard food flavor" (GB 30616-2020) and other 38 national food safety standards and 4 amendments Announcement, the State Drug Administration on the key varieties of information tracing system construction announcement (No. 111 of 2020) and the National Food Safety Standards Review Committee secretariat on the request for glue base and its ingredients, such as 18 national standards for food safety (draft for comments).
policy document information is as follows: Table 1 This week released a list of policy documents data sources: relevant departments, Seddy consultants to organize key analysis: October 13, the State Drug Administration issued a good job in the key varieties of information tracing system construction announcement.
announcement called for the implementation of the Drug Administration Law and the State Council on the deployment of drug traceability, and actively promote the construction of a drug information traceability system, improve the level and efficiency of drug supervision, and effectively ensure the quality and safety of drugs.
Drug market license holders shall implement the main responsibility of drug quality management throughout the process, establish an information-based traceability system, collect traceability information on the whole process, and, by December 31, 2020, basically realize the traceability of key varieties such as selected varieties, narcotic drugs, psychotic drugs and blood products in the centralized procurement of national drugs.
, research and development of new drugs registration declaration, this week added 162 cases of acceptance number.
from the drug category, the largest number of chemical drug registration and declaration acceptance, 109 cases, accounting for 67%;
from the registered declaration type, 119 cases were supplementary applications, accounting for 74%, imports accounted for 15%, new drugs received 4%, imitation acceptance accounted for 4%.
From the point of view of the declared enterprises, the largest number of enterprises received this week is Beijing Novarma Pharmaceutical Co., Ltd., the number of cases accepted is 6 cases, followed by Haikou City Pharmaceutical Factory Co., Ltd., Dano and Nord Co., Ltd., AstraZenecon Pharmaceutical Co., Ltd., Pfizer Investment Co., Ltd. and Weiwei (China) Pharmaceutical Co., Ltd., the number of cases received is 4 cases.
Figure 1 This week the national acceptance of registered drug category data source: Seddy Consultants Pharmaceutical Health Industry Brain Map 2 This week National Acceptance of Drug Registration Declaration Type Data Source: Seddy Consultants Medical Health Industry Brain Map 3 This week the number of national enterprises declared drug registrations TOP10 data source: Seddy Consultants Medical Health Industry Brain Consistency Evaluation, a total of 39 drugs this week consistent evaluation status update.
13 of them have been documented and are pending approval.
13 completed drugs, mainly related to ibuprofen tablets, oxalic acid esxiplain tablets, calcium acetate tablets, coenzyme Q10 tablets, cephalosporine tablets, hydrochloride iodide tablets, hydrochloric acid Prakso tablets, Ida lafon injections and isoniazid tablets a total of 9 varieties.
Table 2 Consistency Evaluation Drug Data Source: Sadie Consultants Medical Health Industry Brain Focus Analysis Coenzyme Q10 Tablets have the function of promoting phosphoxication reaction and protecting the structural integrity of biofilms.
this product is a widely available fat-soluble quinoid compounds in organisms, different sources of coenzyme Q10 its side-chain isoprene unit number is different, humans and mammals are 10 isoprene units, so called coenzyme Q10.
Q10 plays an important role in proton displacement and electron transmission in the respiratory chain of the body, it is also an activator of cellular respiration and cell metabolism, and is also an important antioxidant and non-specific immune enhancer.
investment and financing wind to the domestic investment and financing market, this week in the field of medicine and health, a total of 7 key investment and financing incidents, disclosed the amount of financing of 1.35 billion yuan.
investment targets for Ykosai Biology, Manshi, Nordstron, Boya, Mayo Oral, Zhidao Biology, Art Magic Shenzhou, mainly involved in innovative technology research and development, oral medical services, gene editing and other fields.
the amount disclosed, Boya has the highest amount of financing, at Rmb450m.
table 3 Domestic investment and financing event data source: EdiGene, Inc., a biopharmaceutical company dedicated to accelerating drug research and developing innovative therapies for a variety of genetic diseases and cancers through international cutting-edge genomic editing technology.
Boya has established an in vitro cell gene editing treatment platform with independent intellectual property rights for hematopoietic stem cells and T-cells, an in vivo gene therapy platform based on RNA single base editing technology, and a high-volume genome editing and screening platform dedicated to targeted drug development.
founded in 2015, the company is headquartered in Beijing and has offices in Guangzhou and Cambridge, USA.
October 13, 2020, biopharmaceutical company Boya was announced to have successfully completed the 450 million yuan B round of financing.
This round of financing by Sanzheng Health Investment Lead Investment, Sequoia Capital China Fund, Yahui Investment, Kunlun Capital and Investment, the company's existing investors IDG Capital, Lilly Asia Fund, Huagai Capital, Songyu Capital and Investment, continue to support the company's development.
this round of financing will be used to advance the clinical transformation of the research and development pipeline and further expand the team.
the overseas investment and financing market, there were 11 key investment and financing incidents in the pharmaceutical and health sector this week, with a total amount of more than $1,374 million disclosed, with the target targets of OriBiotech, Instylla, 98point6, RayzeBio, WaveClear, JAXJOX, ScriptDrop, Vineti, Kanaph, GetSetUp, NymHealth, etc., are mainly involved in gene and cell therapy drugs, telehealth services, ultrasound treatment equipment and other fields.
, 98point6 received $118 million in financing, the highest amount.
table 4 Of this week's overseas investment and financing event data source: Seddy Consultants Medical Health Industry Brain Focus Analysis 98point6 is a telemedicine startup whose platform combines clinicians with AI to provide text-based care.
, chief executive of 98point6, is a former Microsoft executive and cozi founder.
98point6 is dedicated to providing an app that lets users chat with certified physicians.
can start a conversation with your doctor once all users have registered, without an appointment.
98point6's platform-specific applications are available on both Android, iOS, and PC side, and provide health management solutions for individuals, families (including families 1 year and older) and businesses.
, the app is currently only available in Washington state.
the company plans to expand its services in the future and increase services such as emergency care, chronic illness management and weight loss.
round of financing is led by L Catterton and Actant Capital, with new and old investors.
the company intends to use the money to further invest in research and development and expand medical practice.
98point6 is committed to providing personalized counseling, diagnosis and treatment to patients across the country.