21 Jianxun Daily | Huawei into the field of heavy ion therapy; Xi'an yesterday added 95 new confirmed cases

Source丨21st Century Business Herald

Editor 丨Xu Xu

Here is 21 Health News Daily! Welcome to pay attention to the latest events in the pharmaceutical and health industry with the new health team of 21st Century Business Herald!

01 Policy Trends

●The "First Class Medical Device Product Catalog" was officially implemented

A few days ago, the State Food and Drug Administration issued a notice on the implementation of the "First Class Medical Device Product Catalog" related matters. In order to better guide the filing management of Class I medical devices, in accordance with the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council) and the Classification Rules for Medical Devices (Order No. 15 of the State Food and Drug Administration, hereinafter referred to as Order No. 15), the State Drug Administration organized the revision and issuance of the Catalogue of Class I Medical Devices, which came into effect on January 1, 2022.

02 Approval of pharmaceutical devices

●The State Food and Drug Administration approved the listing of darcily tablets of isethionate

Recently, the State Drug Administration approved the listing of The Class 1 innovative drug Darcili tablets (trade name: iReseon) declared by Jiangsu Hengrui Pharmaceutical Co., Ltd. through the priority review and approval procedure. The drug, in combination with fulvestrant, is indicated for patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative recurrence, or metastatic breast cancer who have previously experienced disease progression after receiving endocrine therapy.

Dalpiciclib is a cyclin-dependent kinase 4 and 6 (CDK4 and CDK6) inhibitor that reduces retinoblastoma protein phosphorylation levels downstream of the CDK4 and CDK6 signaling pathways and induces cell G1 phase blocking, thereby inhibiting tumor cell proliferation. The listing of the drug provides new treatment options for breast cancer patients.

●The State Food and Drug Administration approved the listing of proline hepagliflozin tablets

Recently, the State Drug Administration approved the listing of Jiangsu Hengrui Pharmaceutical Co., Ltd. for the listing of the 1 new drug proline hepagliflozin tablets (trade name: Ruiqin). The drug is an innovative drug independently developed in China and has independent intellectual property rights, which is suitable for improving the blood glucose control of adult type 2 diabetes patients.

Proline hengliflozin is a sodium-glucose synergistic transporter 2 (SGLT2) inhibitor that increases urinary glucose excretion by inhibiting SGLT2, reducing the reabsorption of tubular filtered glucose, lowering the renal threshold of glucose, and thus increasing urinary glucose excretion. The listing of this variety provides new treatment options for adults with type 2 diabetes.

●The State Food and Drug Administration approved the listing of Qirui Gastric Shu Capsules

Recently, the State Drug Administration approved the listing of Class 1.1 innovative drug Qirui Gastric Shu Capsules. This product is an innovative drug of traditional Chinese medicine developed on the basis of preparations of medical institutions, and has carried out randomized, double-blind, positive drug parallel control and multi-center clinical trials. Clinical trial results have shown that it can be used for the treatment of gastric pain caused by mild to moderate chronic non-atrophic gastritis with erosion damp heat stasis. The holder of the drug marketing authorization is Jianmin Pharmaceutical Group Co., Ltd. The listing of this variety provides new treatment options for patients with chronic gastritis.

03 Capital markets

●The CSRC decided to terminate the registration procedure for the issuance of the Chuanger BioTech Innovation Board

Recently, the China Securities Regulatory Commission issued an announcement that Chuanger Bio took the initiative to request the withdrawal of registration application documents and decided to terminate its science and technology innovation board issuance registration process.

Chuanger Bio was successfully listed on the New Third Board on October 8, 2014, and has since issued several delisting announcements to sprint to the main board. On June 23, 2020, Guangzhou Chuanger Biotechnology Co., Ltd. submitted an application for an initial public offering of shares and listing on the Science and Technology Innovation Board, but due to the expiration of financial information, the IPO review was suspended twice.

According to public information, Guangzhou Chuanger Biotechnology Co., Ltd. was established in August 2002, is a master of biomedical active rubber raw materials key technology, deeply engaged in the field of active collagen raw materials, medical equipment and biological skin care products, research and development, production, sales in one of the high-tech enterprises. As the pioneer of China's collagen patch dressing products, Chuanger has the country's first sterile class III collagen patch dressing.

●Xuanzhu Biotech announced the completion of a new round of financing of 610 million

On January 3, Xuanzhu Biologics, a subsidiary of Sihuan Pharmaceutical, announced the completion of a new round of financing, with a pre-investment valuation of 6.3 billion yuan, a financing amount of 610.5 million yuan, and a post-investment valuation of 6.9105 billion yuan.

After nearly 10 years of construction and development, the company has brought together nearly 400 excellent teams led by returnee scientists, with the ability of independent research and development of innovative drugs, forming a complete R&D system, with complete drug development and industrialization capabilities, and does not rely on License in and CRO, with the ability of continuous innovation and continuous output. Relying on the commercialization capabilities of its parent company, Sihuan Pharmaceutical, Xuanzhu Bio is now transforming from Biotech to BioPharm, and gradually becoming a company with excellent R&D and industrialization capabilities.

04 Industry events

●Huawei has entered the field of heavy ion therapy

Recently, Huawei Technologies Co., Ltd. and Lanzhou KejinTaiji New Technology Co., Ltd. (a subsidiary of the Chinese Academy of Sciences Holdings Co., Ltd. and the Institute of Modern Physics of the Chinese Academy of Sciences). Signed a comprehensive cooperation framework agreement in Lanzhou, indicating that it will jointly promote the research and development and application of carbon ion therapy systems (medical heavy ion accelerators) in the medical industry.

There are many IT giants active in the field of medical devices, foreign Apple, Google, etc. have products to obtain FDA medical device certification, and domestic ByteDance, Tencent, Ali, Meituan, Baidu, Xiaomi, etc. are competing to enter the game. As an early entrant, Huawei has tried many attempts in the medical track, consumer terminals, hospitals and medical companies have layouts, and the first remote 5G animal surgery and human surgery are completed by Huawei in cooperation with Unicom and Mobile.

● Xi'an yesterday added 95 new local confirmed cases

According to the National Health Commission, from 0 to 24:00 on January 3, 31 provinces (autonomous regions and municipalities directly under the Central Government) and the Xinjiang Production and Construction Corps reported 175 new confirmed cases. Among them, there were 67 imported cases (29 cases in Shanghai, 13 cases in Guangdong, 9 cases in Fujian, 4 cases in Guangxi, 3 cases in Sichuan, 3 cases in Yunnan, 1 case in Tianjin, 1 case in Jiangsu, 1 case in Zhejiang, 1 case in Shandong, 1 case in Henan, 1 case in Hunan), including 5 cases from asymptomatic infected people to confirmed cases (4 cases in Guangdong and 1 case in Hunan); 108 cases of local cases (95 cases in Shaanxi, all in Xi'an City; 8 cases in Zhejiang, all in Ningbo City; 5 cases in Henan, including 2 cases in Luoyang City, 2 cases in Xuchang City, and 1 case in Zhengzhou City), Including 4 cases converted from asymptomatic infected people to confirmed cases (all in Henan). There were no new deaths. There were 3 new suspected cases, all of which were imported from abroad (all in Shanghai).

● Beckman Coulter joined hands with local enterprises to launch the "Behuakang" innovative brand

Recently, Beckman Coulter reached a strategic cooperation with Shanghai Accuride Biotechnology Co., Ltd. and Shandong Ecoda Biotechnology Co., Ltd., and authorized these two enterprises to be the first batch of "Beihuakang" innovative brand cooperation units. Beckman Coulter's new localization innovation brand "Behuakang" has become an important process in building a localized innovation ecosystem.

Dr. Jiang Zhiming, Senior Vice President of Beckman Coulter Global and General Manager of China, introduced that "Behuakang" is not only a product brand, but also a service and value brand, Beckman Coulter will continue to deepen the construction of a localization ecosystem through the creation of "Behuakang" innovative brand, accelerate localization research and development and production, from the four aspects of smart medical care, health and disease management, lean management and gold medal services, and work with partners to create an excellent customer experience for the whole industry.