Pharmaceutical and Health Industry Weekly Report (August 3 - August 7)

Content Joint Release: Seddy Consultants, Sina Pharmaceuticals Week Overview: Policy and Regulation, the Drug Review Center of the State Drug Administration has formulated the Guidelines for Clinical Trials of Adamu Mono-Injectable Biosyclinders and the Guidelines for Clinical Trials of Bevajuma Anti-Injectable Biosyclinders to guide the clinical development of relevant drugs, provide reference technical standards; Registration report acceptance number, 18 consistency evaluation acceptance number, and 11 declaration production application number status update, investment and financing, a total of 7 investment and financing events occurred in the field of domestic medical and health, the amount of disclosure of financing is 2.726 billion yuan, a total of 16 key investment and financing events in the field of foreign medical and health, the total amount of disclosure financing is about 434 million U.S. dollars ... The pharmaceutical and health industry this week inventory, wonderful continue! 1. Policy guidelines were issued this week in only two cases, namely, the Guidelines for Clinical Trials of Bevaddin Anti-Injectable Bioseal Drugs and the Guidelines for Clinical Trials of Adamu's Anti-Injectable Bioseal Drugs.
Specific information is as follows: Table 1 The list of policy documents released this week focuses on the analysis: the original drug Adalimumab (commodity name: Sumerium) and Bevacizumab (commodity name: avettine) were developed by Abbvie and Roche, respectively, because the relevant patents have expired, pharmaceutical companies have joined the development of biosimilars.
In order to guide the clinical research and development of Adamu's anti-injection and bevaddin biosyclinds in China, and providing reference technical standards, under the deployment of the State Drug Administration, the Drug Review Center organized the development of the Guidelines for Clinical Trials of Adamu's Anti-injectable Biosysampsy Drugs and the Guidelines for Clinical Trials of Bevaddin's Anti-Injection Biosyclinders to discuss the design and review of clinical trials of two biosyclinic drugs from a review perspective.
so far, the Center has issued clinical trial guidelines for five popular biosysor drugs, the first three of which are lilaglutide, quertogumin and litoxima resistance.
, research and development of new drug registration declaration, this week added 155 cases of acceptance number.
drug category, the largest number of chemical drug registration declarations received, 125 cases, accounting for 81%;
the type of registration declaration, 104 cases were supplementary applications, accounting for 76%, imitation acceptance accounted for 9%, new drug acceptance accounted for 6%, import acceptance accounted for 9%.
from the reporting enterprises, this week's largest number of enterprises are Bayer Healthcare Co., Ltd., the number of acceptances are 7 cases, followed by Pfizer Investment Co., Ltd., the number of acceptance of 6 cases.
1 This week the national acceptance of the registration of drug category chart 2 this week the national acceptance of drug registration declaration type chart 3 this week the national enterprises to declare the number of drug registration TOP5 consistency evaluation, this week added 18 application numbers.
from the product point of view, mainly involved in Entikave dispersion tablets, Palitol injection, hydrochloric acid Palonosjon injection, injection of sodium cephalosporine and other 13 varieties.
from the application enterprise, Shandong Lu Anti-Pharmaceutical Co., Ltd., Shanxi Wichida Bright Pharmaceutical Co., Ltd., Tongfang Pharmaceutical Group Co., Ltd. and Zhengda Tianqing Pharmaceutical Group Co., Ltd. have the largest number of applications, the number of 2 cases.
11 application numbers were updated this week in terms of the declaration of production status on Form 2 of this week's consistency evaluation application number list.
from the product point of view, mainly related to Monrust sodium chewing tablets, hydrochloric acid Klinmycin capsules, Engli net tablets and other 7 varieties.
from the application type, Edarafun right- injection is a class 1 innovative drug. Table
3 This week's report on the production status update of the application number list key analysis: Ida Lafun right-turnalcohol injection is the first sound pharmaceutical industry after 13 years of independent research and development with independent intellectual property rights of a class of innovative drugs, used to treat acute ischemic stroke.
recent years, the incidence of stroke in China has shown an upward trend, the total number of stroke patients is about 11 million, an increase of 2.4 million per year, 1.1 million people die each year from stroke.
Idarapin rightol injections with a 4:1 ratio combination scientifically matched two active ingredients Ida lafonol (antioxidants and free-based severance removers, removal of hydroxy freeyls, nitric oxide freelance and ONOO-ions) and right-hand olols (bicyclin monosteroids, inhibit brain deficiency) The expression of inflammatory cytokines TNF-alpha, IL-1 beta and inflammatory protein COX-2 and iNOS caused by blood re-perfusion can significantly reduce and improve the brain nerve damage caused by acute ischemic stroke by using two components to remove free-base, anti-inflammatory and improve blood-brain barrier permeability.
approval of the drug will hopefully become a more effective clinical treatment for acute ischemic stroke, benefiting more stroke patients.
, investment and financing wind to the domestic investment and financing market, this week in the field of medical and health a total of 7 investment and financing events, disclosed the amount of financing of 2.726 billion yuan.
investment targets for Exegenesis, Arno Pharmaceuticals, Tulu Port Bio, Union Medicine, Lepu Bio, minimally invasive electrophysiology and Yichen Medicine, mainly involved in medicine, medical equipment and other fields.
disclosed amount, Lepu Bio-Finance amounted to the highest amount, reaching 1.291 billion yuan.
4 Highlights of this week's domestic investment and financing events: Lepu Bio was founded in 2018 by its predecessor, Dr. Pu Zhongjie, founder of Lepu Medical, focusing on the development and construction of innovative cancer treatment product platform.
company around the tumor immunotherapy, the development of focus on PD-1, PD-L1 and core combination drug (tumor virus, ADC) innovative tumor treatment product platform, while building target discovery, drug development, development and production of open industry platform.
At present, Lepu Bio has 9 subsidiaries such as Houde Oko, Han Zhong Bio, Shanghai MeiYaYu, Shanghai Airlines Jia Incubator, the company's 12 core products, 7 are in the clinical stage, 3 Sino-US double-report products.
this round of financing will be used to accelerate the development, clinical trials and product launch of several of the company's new anti-tumor drugs.
In terms of overseas investment and financing markets, there were 16 key investment and financing events in the pharmaceutical and health sector this week, with a total amount of about $433.9 million disclosed, targeting companies such as Kyber Data Science and NuView Life Sciences, mainly in the fields of medical devices, medical services and pharmaceuticals.
, Taysha Gene Therapies received the largest $95 million in financing.
5 Highlights of overseas investment and financing this week: Dallas, Texas-based Taysha Gene Therapies recently completed a $95 million B-round over-funding round.
, which was founded on April 29th, has so far received two rounds of funding totalling more than $100m for its focus on gene therapy for rare diseases, the current hot area.
Taysha will submit multiple applications for clinical trials of gene therapy in 2021 to push more therapies into clinical phases.
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