Medical and Health Industry Weekly Report (August 31 - September 4)

Joint release: Sina Pharmaceuticals, Saidi consultants a week overview of policy and regulations, this week issued three policy documents, respectively, "real-world research to support children's drug research and development and review of the technical guidelines (trial)," "on the release of small live pills (big honey pills) in the heterogeneity of organic compounds supplementary testing methods" and "drug registration review conclusions dissent resolution procedures (trial)"; 39 cases of drug registration declaration acceptance number, 8 consistent evaluation acceptance number, and 18 declaration of production application number status update; investment and financing, a total of 15 investment and financing incidents in the field of domestic medical and health, disclosed financing amount of 4.305 billion yuan; Medical and health industry this week inventory, wonderful continue! Policy direction is marked by three policy releases this week, with "Technical Guidelines for Real-World Research to Support Drug Research and Review in Children (Trial)" being the policy document of this week's focus. The information in the
policy document is as follows: Table 1 A list of policy documents released this week focuses on the analysis of August 31st morning, the National Drug Administration's Drug Review Center issued Article No. 22 of 2020 - On the release of the "Technical Guidelines for Real-World Research in Support of Drug Research and Review in Children" (hereinafter referred to as "Guidelines"), which is the After the "Guidelines for Real-World Evidence Support Drug Research and Review (Trial)" and the "Draft for Comments" on "Technical Guidelines for Real-World Evidence Support for Child Drug Research and Review" in May, another policy document on real-world research supporting children's research and development has once again raised concerns about the scope of application of real-world evidence to support child drug research and development.
guidance states that Real World Research (RWS), as one of the new research methods, has been gradually used to support the development and review of childhood medicines, to support the registration of new drugs, the expansion of childhood adhesives, and the improvement of dose programmes for children.
At the same time, the guiding principles clearly distinguish between real-world research and traditional randomized controlled clinical trials and reasonable integration, point out the common situation of real-world research for children's drug research and development in China, and list two real-world studies for china's children's drug research and development cases, for the industry will have a very important reference value and guiding significance, regulatory agencies in the real drug research has taken a solid and important step.
139 new cases this week in the registration and declaration of new drugs for research and development.
from the drug category, the largest number of chemical drug registration and declaration acceptance, 116 cases, accounting for 84%, biological products accounted for 12% of the number of acceptance, the number of Chinese medicine acceptance accounted for 4%.
from the registration declaration type, 107 cases were supplementary applications, accounting for 77%, new drugs accounted for 10%, imitation acceptance accounted for 4%, import re-registration accounted for 3%.
From the point of view of filing enterprises, the largest number of enterprises received this week is Beijing Novarma Pharmaceutical Co., Ltd., the number of cases received is 15 cases, followed by Fessen Yuska Bihuari Pharmaceutical Co., Ltd., the number of cases received is 12 cases.
Figure 1 This week the national acceptance of registration declaration drug category figure 2 this week the national acceptance of drug registration declaration type figure 3 This week the national enterprises declared the number of drug registration TOP5 consistent evaluation, this week added 8 application numbers.
From the product point of view, mainly involved in benzodiacycline chloride tablets, hydrochloric acid metformin slow release tablets, injection of sodium omeprazole, cephalosporine dispersion tablets, titration tablets, omeprazole intestinal capsules, hydrochlorochloride tablets and other 7 varieties.
from the application enterprises, only Tianjin Central Pharmaceutical Co. , Ltd. cephalosporine dispersal tablet application number reached 2 cases, the rest of the enterprise application number is 1 case.
Form 2 This week, a total of 18 application number production status updates were reported on the list of consistent evaluation application numbers.
From the product point of view, mainly involved in reschuvastatin calcium tablets, isopropyl bromide inhalation solution, fumaric acid nofovir dipropylate tablets, Malay acid aphatini tablets, Adamo monoantigen injection, left oxyfluoxacin drop eyes There are 13 varieties, such as liquid, Ebersatan hydrochlorochloride tablets, hydrochloric acid quretamin tablets, temoxamine capsules, mixed sugar electrolyte injections, converted sugar injections, injections with Esomerazole sodium, calcium folate injections, etc.
the type of application, only Adamo monoantigen injections are new drugs, and the rest are generics.
Table 3 This week's list of application numbers for production status updates focused on the analysis of September 3, 2020, the State Drug Administration issued a batch of drug approval documents to be received information, Xinda Bio's Adamo single anti-injection in the first place, meaning that Xinda Bio's Adamo single anti-injection with priority evaluation qualifications successfully and quickly approved the market, becoming the third domestic Adamo single anti-biological similar drugs.
Adamo monoantigen injection is the world's first approved all-human source anti-tumor necrotic cause ɑ (TNF-ɑ) monoclonal antibody, specifically binding to soluble human TNF-ɑ and blocking its interaction with cell surface TNF ligands p55 and p75, effectively blocking the inflammatory effects of TNF-ɑ.
Adamu single antigen research drugs (commodity name: Shumeile) developed by AbbVie, the original research drugs long occupied the top ten places in the global drug sales rankings, 2019 global sales of 137.4 billion yuan, of which the original research drugs accounted for 132 billion yuan, bio-similar drugs have a great market space.
So far, including Xinda BioAdam single anti-injection (Su Lixin), a total of 3 domestic Adamo single anti-biosygenic drugs have been approved for listing, the remaining two are november 7, 2019 by Baiotai declared the listing of Greeley, December 6, 2019 by Haizheng Pharmaceuticals declared listed An Jianning.
the lowest bid price of the variety is 1150 yuan, of which 14 are in the winning area of Baiotai and 13 are in Haizheng Pharmaceuticals.
addition, the 2020 Baiotai semi-annual report shows that the first half of Greeley domestic sales of 48.7864 million yuan.
Synda Bio's Adamo single anti-approval listed, means that Xinda Bio has entered the field of lung tumor drugs, but facing greater market competition pressure, how to compete with the listed two enterprises price, how to commercialize sales and continue to expand the adaptive disease is its market to be urgently considered.
investment and financing wind to the domestic investment and financing market, this week in the field of medicine and health, a total of 15 investment and financing incidents, disclosed the amount of financing of 4.305 billion yuan.
Investment targets for China and the United States Huashitong, Yisi Medical, Several Kun Technology, Huitron Medical, Lifeline Biology, Kang for the century, Yan Huakang, minimally invasive medical robots, oral Shinkansen, Tongli Bio, Huayu Biology, Fangrun Medical, Lingda Bio, Yi's Meikang, Life Creatures, mainly involved in medicine, medical equipment, medical services and other fields.
the amount disclosed, minimally invascope medical robot financing amounted to 3 billion yuan. Table
4 This week's domestic investment and financing events focus on the analysis of the world bio is a clinical stage of biotechnology, founded at the end of 2018, has completed tens of millions of U.S. dollars of round A financing, in just over half a year to establish a complete international high-level research and development and clinical team across Shanghai, Beijing, the United States and Australia.
focuses on cancer research, based on a deep understanding of disease biology, the establishment of differentiated research and development pipeline, the main research and development pipeline includes in the clinical phase of the FAK inhibitor IN10018, in the IND preparation stage INX0001 and in the exploration phase of IN30101, mainly used to target the treatment of melanoma, non-small cell carcinoma, head and neck cancer, liver cancer, rectal cancer and other cancer diseases.
The round of financing was jointly led by Nanjing Jiangbei New Area's Ruiyou Kangke Investment Fund (Enran Venture Ventures) and China Growth Capital, with the participation of InnoMed Capital and Grand Yangtze Capital, raising 130 million yuan to accelerate the clinical development of IN10018 products and the layout of new pipelines.
IN10018 is an efficient and highly selective ATP competitive adhesive plaque kinase (FAK) inhibitor that is being developed for a variety of cancer treatments including staphylactic melanoma and NRAS mutant metastatic melanoma, diffuse stomach cancer and platinum-resistant ovarian cancer.
rapid progress in clinical development of IN10018 over the past year and has conducted three clinical studies in the United States, Australia and China, with clinical patient recruitment progressing smoothly.
years, a large number of enterprises have invested in anti-tumor biopharmaceasil research and development, especially in colorectal cancer, melanoma and other fields of research and development projects pile up, set off a wave of investment and financing.
in various research and development targets, FAK inhibitors have shown effective tumor suppression, which is one of the key directions for research and development of new drugs in China.
round of bio-financing is the microcosm of capital research on high-risk tumor drugs in China and important target research, promoting the further development of anti-tumor drugs.
the overseas investment and financing market, 11 key investment and financing events in the pharmaceutical and health sector this week, with a total of more than $388 million disclosed, were invested in Erasca, NeuroPace, Picnic Health, Mobio Interactive, LUCA Science, mfine, Biofourmis, SHINE Medical Technologies, Miracor Medical, ENvizion, PhotoniCare, and other fields.
, Biofourmis received $100 million in financing, the highest amount. Table
5 This week's overseas investment and financing event focuses on Biofourmis, an artificial intelligence healthcare company that uses artificial intelligence and machine learning to develop health management solutions that provide patient-facing tools such as wearable biosensors, app for reporting symptoms, and tools for remote monitoring by doctors.
Biofourmis focuses on three therapeutic areas: cardiovascular, respiratory and oncology.
The C round of financing, led by Vision Fund 2, will involve $100 million from existing investors Openspace Ventures, MassMutual Ventures, Sequoia Capital and EDBI, and will be used to develop, validate and commercialize a variety of published and unrealized digital treatment solutions covering heart disease, respiratory tract, oncology and pain, with a focus on major markets in the United States and Asia, including asia pacific, China and Japan.
Heart failure is currently the main focus area for wearables, with more than 6.5 million people suffering from heart failure in the United States and more than $30 billion spent by the health system, which can help clinicians predict heart failure events weeks in advance and intervene before they occur.