Morning, here's 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!
●The national medical device supervision and sampling inspection of 26 batches (units) of products are not up to standard
On the 17th, the State Food and Drug Administration issued a notice on the release of the results of the national medical device supervision and sampling test ((No. 4) (No. 89 [2021]).
In order to strengthen the supervision and management of medical devices and ensure the safety and effective quality of medical device products, the State Drug Administration organized product quality supervision and sampling inspection of 14 varieties such as semiconductor laser treatment machines, high-frequency surgical equipment, and synthetic resin teeth, and a total of 26 batches (units) of products did not meet the standard regulations. The specifics are notified as follows:
First, the sampling items do not meet the requirements of the standard of medical device products
(1) Semiconductor laser treatment machine 1: Wuhan Love Technology Co., Ltd. production, involving marking does not meet the standard regulations.
(2) 1 carbon dioxide laser treatment machine: Changchun Dimei Optoelectronic Technology Co., Ltd. production, involving instructions for use, laser pulse output mode and its time characteristics do not meet the standard regulations.
(3) 2 sets of high-frequency surgical equipment: produced by Hangzhou Dedao Medical Equipment Technology Co., Ltd. and Shandong Xinhua Health Industry Co., Ltd., respectively, involving the accuracy of control devices and instruments that do not meet the standard regulations.
(4) Synthetic resin teeth 1 batch: Shanxi Changzhi Dental Materials Co., Ltd. production, involving the size of the teeth does not meet the standard regulations.
(5) 1 endoscopic cleaning and disinfector: produced by Guangzhou Meimei Medical Technology Co., Ltd., the timing device involved does not meet the standard regulations.
(vi) Flexible contact lens 1 batch: MI GWANG CONTACT LENS CO., LTD. production, involving the total diameter, base arc radius or the height of the arrow for a given bottom diameter does not meet the standard regulations.
(7) Nerve and muscle stimulator 1 set: Harbin Guoji Xiangyun Medical Device Co., Ltd. production, involving instructions for use does not meet the standard regulations.
(8) 7 batches of surgical gowns: jiangsu health care medical technology co., LTD., Nanchang Huayi medical device co., LTD., Nanchang Aokang medical device co., Ltd., Nanchang Yimin medical hygiene materials co., LTD., Sichuan Hengming Science and Technology Development Co., Ltd., Weihai Hongyu non-woven products co., Ltd., Xinxiang Huashu medical equipment co., LTD. production, involving water impermeability (non-critical area of the product), sterility, swelling strength - dry state (product key area), Expansion and breaking strength - wet state (product critical area), resistance to microbial penetration - dry state (non-critical area of product),
Breaking strength - dry state (critical area of the product), breaking strength - wet state (critical area of the product) do not meet the standard requirements.
(9) Sleep apnea treatment equipment 1: Suzhou Anmeng Medical Equipment Co., Ltd. production, involving maximum pressure restriction, airflow resistance does not meet the standard regulations.
(10) 4 gastric lavage machines: harbin Dapeng medical equipment co., LTD., Jiangsu Keling medical device co., LTD., Nanjing Daofen Electronics Co., Ltd., Yangzhou Kaida medical equipment co., LTD. production, involving samples can not be used normally during the inspection process, limit pressure, pressure change, suction conversion device, noise, input power does not meet the standard regulations.
(11) 2 ECG machines: produced by Henan Yun ECG Network Technology Co., Ltd. and Shenzhen Bangjian Biomedical Equipment Co., Ltd., all ECG machines involved must have the function of protection against defibrillation effects and do not meet the standard regulations.
(12) Disposable human venous blood sample collection needle 1 batch, produced by Guangzhou Yangpu Medical Technology Co., Ltd., involving hoses that do not meet the standard regulations.
(13) 2 sets of intermediate frequency electrotherapy instruments: produced by Beijing Dongjiehua Medical Equipment Co., Ltd. and Beijing Tianchangfu Medical Equipment Manufacturing Co., Ltd., respectively, involving continuous leakage current and patient auxiliary current and input power at normal working temperature do not meet the standard regulations.
(14) Natural latex rubber condoms 1 batch: marked Shandong Yaqi Latex Technology Co., Ltd. production, involving blast volume and pressure does not meet the standard regulations.
The specific circumstances of the above sampling products that do not meet the requirements of the standard are shown in the annex.
Second, for the above-mentioned products found in the sampling inspection that do not meet the requirements of the standard, the State Drug Administration has required the provincial drug supervision and management department where the enterprise is located to make an administrative decision in a timely manner and announce it to the public in accordance with the requirements of the Regulations on the Supervision and Administration of Medical Devices, the Measures for the Supervision and Administration of the Production of Medical Devices, and the Measures for the Administration of the Recall of Medical Devices. Provincial drug supervision and management departments should urge enterprises to conduct risk assessments of products that do not meet the requirements of the standards, determine the recall level according to the severity of medical device defects, take the initiative to recall products and disclose recall information; urge enterprises to find out the reasons for product failure as soon as possible, formulate rectification measures and rectify them on schedule.
●Gilead/Galapagos oral JAK1 inhibitors for the treatment of ulcerative colitis are approved by the European Union
Gilead Scientific Partner Galapagos NV recently announced that the European Commission has approved a new indication for the oral anti-inflammatory drug Jyseleca, a once-daily OR JAK1 priority inhibitor for the treatment of adult patients with moderate to severely active ulcerative colitis who are inadequate, unresponsive or intolerant to conventional therapies or biologics.
●Yichang Renfu Pharmaceutical Co., Ltd. declared a new indication for the sedative drug ramazolam
On the 17th, the CDE latest announced that Yichang Renfu Pharmaceutical, a subsidiary of Renfu Pharmaceutical, has submitted a new application for the listing of "rimazolam besylate for injection". According to public information, this is the first Class 1 new drug approved for listing by Yichang Renfu Pharmaceutical, which has previously been approved for listing in China in 2020, and the indication is colonoscopy sedation.
●Baili Tianheng's application for listing on the Science and Technology Innovation Board has been accepted
On November 17, Sichuan Baili Tianheng Pharmaceutical Co., Ltd. applied for listing on the Science and Technology Innovation Board. Essence Securities is its sponsor and intends to raise RMB1.422 billion.
According to the prospectus, Baili Tianheng is a modern biomedical enterprise integrating drug research and development, production and marketing, with a business sector of chemical preparations and proprietary Chinese medicine preparations and innovative biologics business sector, and has a full range of drug research and development production capabilities including small molecule chemical drugs, large molecule biological drugs and antibody conjugated drugs (ADC drugs).
●Anxu Biologics IPO on the Science and Technology Innovation Board today
688075.SH announced that the company's shares will be listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange on November 18, 2021.
Since its inception, Anxu Biology has always focused on the research and development, production and sales of POCT reagents and instruments, and its main business has not changed. Based on the bio-raw material technology platform independently developed and produced by antigen antibodies, as well as the mature immunochromatography and dry biochemical diagnostic technology platform, the company has developed and formed a POCT reagent covering eight major fields of drug detection, infectious disease detection, chronic disease detection, pregnancy detection, tumor detection, myocardial testing, biochemical detection, allergen detection, and the products are exported to the United States, Germany, the United Kingdom, Canada, Russia, Mexico, Thailand, Indonesia and Poland and other countries. It has become one of the few Chinese in vitro diagnostic product suppliers that can compete with multinational in vitro diagnostic industry giants in the international market of POCT.
●Danxu Biology and Peking University team jointly researched new crown neutralizing antibodies
0.6 g antibody one needle, one needle for one month! At Beijing Ditan Hospital, covid-19 infected people received a "sympathetic drug" called DXP-604 independently developed in China. After use, the viral load in the patient's body dropped significantly, and the symptoms such as wheezing and decreased taste and smell improved significantly, and some patients have recovered and been discharged from the hospital.
The drug was jointly developed by Xie Xiaoliang's team at Peking University and Danxu Biologics. On November 16, the reporter of Science and Technology Daily exclusively interviewed the leader of the R&D team, Xie Xiaoliang, Chair Professor Li Shau Kee of Peking University. He said that the characteristics of a single antibody replacing the "antibody pair" make its production cost will be less than one-third of that of other drug candidates, and Danxu has reached a cooperative development intention with Sinopharm Group China Biologics.
●The first Alzheimer's vaccine enters clinical trials
On November 16, US time, Brigham and Women's Hospital announced that it will launch a Phase 1 clinical trial to evaluate the safety and efficacy of a new nasal vaccine in preventing and slowing the progression of Alzheimer's disease (AD). Howard L. Weiner, MD, of Brigham Hospital, said: "The immune system plays a very important role in all neurological disorders, and after 20 years of preclinical work, we can finally take a critical step towards clinical transformation and conduct this landmark first human trial. ”
It is worth mentioning that Tianjing Bio and Enhua Pharmaceutical have obtained the right to develop, produce and commercialize protollin, the immunomodulatory agent used in the vaccine, from Brigham Hospital and Inspirevax (formerly known as "Biodextris") to develop, produce and commercialize it worldwide.
●Fda lifts the import ban on Huahai Pharmaceutical's Chuannan API production base
On the 17th, Huahai Pharmaceutical issued an announcement that the company recently received an official letter from the FDA that the FDA's import ban on its Sichuan south API production base has been lifted. As a result, API products produced at the Chuannan production base and preparation products made from APIs produced at the Chuannan production base can enter the US market normally if they are registered and approved in the United States.
For more information, please download the 21 Finance APP