A group of 6.2 billion people from Pharmaceutical Express has acquired four pharmaceutical companies and several drugs were approved for listing today.

August 14, 2020 / Medical Information List: In the study of gene therapy Phase I/II clinical was shelved by the FDA; Hengrui PD-1 combination therapy first-line treatment of nasopharyngeal cancer Phase III clinical reached the main endpoint; Fuhong Hanyu Quto Zhudan anti-China approved listing; Hep chemical medicine "first-in-class" NASH new drugs approved clinical ... Daily fresh medicine news, speed reading society and you pay attention to! Part 1 Policy Brief State Drug Administration Flying Inspection Equipment Company discontinued the State Drug Administration official website released a message, recently organized a flight inspection of Guangzhou Runhong Pharmaceutical Technology Co., Ltd. and other 4 enterprises, found that the enterprise quality management system has serious defects, does not comply with the relevant provisions of the medical device production quality management norms.
ordered the above-mentioned four enterprises to immediately stop production and rectification.
s proposed acquisition of Qiagen has lapsed after the National Drug Administration's (NMA) part 2 production and observation of Thermo's planned acquisition of Qiagen has failed.
previously, Mr. Seymru said it had reached a conditional deal with Qiagen, but that the two companies' intention to do so would depend on whether the shares in favor of Qiagen's sale exceeded 66.67 percent.
the acquisition agreement between the two companies has lapsed in accordance with the terms, as the minimum acceptance threshold for the acquisition has not been met.
(Sina Pharmaceutical News) Ren association biotech board IPO meeting 13, Ren will bio in the Shanghai Stock Exchange science and technology board IPO application has passed the Shanghai Municipal Committee meeting, the sponsor institution is Guotai Junan.
, according to the prospectos, the IPO is expected to raise 3,005 million yuan, of which about 1.24 billion yuan will be used for new drug research and development projects.
(Pharmaceutical Mission) Yunhong Group 6.2 billion acquisition of 4 pharmaceutical companies recently, Yunhong Group 6.2 billion acquisition of 4 pharmaceutical companies, including 2 pharmaceutical companies, 2 pharmaceutical companies, respectively: Wuhan Sixth Pharmaceutical Co., Ltd., Shanghai Aning Bio (Tong Yin) Pharmaceutical Co., Ltd., Anyang Qiankang Pharmaceutical Co., Ltd., Anyang Qiankang and Pharmaceutical Chain Co., Ltd.
acquisition includes a variety of shareholder interests included in the transfer of shares, including all movable and immovable, tangible and intangible assets owned by the target company.
(dandelion) Part 3 drug information in the study of gene therapy I/II clinical by the FDA shelved recently, Passage in the study of GM1 neuro-glycoside storing gene therapy PBGM01 phase I/II clinical trial was clinically shelved by the FDA, the study may be postponed until about the end of this year, in order to further assess the risks associated with the delivery of the therapy.
(Sina Pharmaceutical News) Hengrui PD-1 combination therapy first-line treatment of nasopharyngeal cancer Phase III clinical reached the main end of the 13th, Hengrui Pharmaceuticals announced that the company injected with karili-pearl single anti-combination cisplatin and Gissytabin first-line treatment of local recurrence or distant metastatic nasopharyngeal cancer random, double-blind, placebo control, multi-center III In the clinical study, the in-period analysis results of the independent data monitoring committee determined that the main research endpoint reached the optimal standard set by the scheme, and the results showed that the patients with partial recurrence or distant metastatic nasopharyngeal cancer treated with Karelli pearl monoantigen and gisectoplabin by injection could significantly prolong the patient's non-progressing survival.
(Hengrui Pharmaceutical Announcement) Wuhan Bio-New Coronary Inactivated Vaccine I./II. Phase I./II. Clinical Trials Showing Good Immunogenicity and Safety The Journal of the American Medical Association published on the 13th the results of the new Coronary Inactivated Vaccine I./II. Phase I./II. Clinical Trials jointly developed by China Bio-Wuhan Biological Products Research Institute of China Pharmaceutical Group and Wuhan Virus Research Institute of the Chinese Academy of Sciences showed that effective induction of neutral antibodies has good immunogenicity and good safety in the human body.
(Immediate Drug News) Hengrui HER2 ADC launched the International Multi-Center Phase I clinical trial on the 13th, Hengrui Pharmaceuticals in the drug clinical trial registration and information publicity platform registration launched SHR-A1811 in HER2 expression or mutation of advanced solid tumor patients in the safety, tolerance, pharmacodynamics and efficacy of open, international multi-center Phase I clinical research.
the study will be conducted in 12 clinical centres around the world, with plans to recruit 150 patients domestically and 226 internationally.
(Pharmaceutical Rubik's Cube) Xi'an Yangsen Apatamine was approved in China the 2nd indications of drug approval documents issued by the State Drug Administration to receive the announcement shows that Xi'an Yangsen's new generation of androgen inhibitor apatamine tablets in the country's second indications market application has been officially approved.
apatamine is a second-generation strong androgen-inhibitor that blocks androgen signaling pathways in prostate cancer cells and inhibits the growth of cancer cells in three ways, delaying distant metastasis.
(State Drug Administration) Fuhong Hanyu Quzhu single anti-China approved listed State Drug Administration issued drug approval documents to be received announcement shows that Fuhong Hanyu's Quto Zhuzhu Single Resistance (HLX02) has been officially approved for listing.
HLX02 is a biosypole developed and produced in strict accordance with international standards for the treatment of HER2-positive early stage breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic stomach cancer.
(National Drug Administration) Hengrui Pharmaceutical SHR1459 tablets to obtain the drug clinical trial approval notice Hengrui Pharmaceutical 13 issued a notice that the company's subsidiary Ruishi Bio recently received the State Drug Administration approved the issuance of the "Drug Clinical Trial Approval Notice."
, on May 11, 2020, a clinical trial application submitted by Ruishi Bio to the State Drug Administration was accepted.
SHR1459 tablets are intended for the treatment of optic neurospinal cord disease.
(Hengrui Pharmaceutical Announcement) Hep chemical medicine "first-in-class" NASH new drug approved in China clinical Heplin pharmaceutical announced that its class 1 innovative drug HPN-01 intestinal capsule recently obtained the National Drug Administration clinical trial license, the adaptive disease is non-alcoholic fatty hepatitis (NASH).
HPN-01, a "first-in-class" candidate developed by Heplin Pharmaceuticals, was approved for clinical use in the United States in February.
(Pharmaceutical Mission) a number of drugs approved for market today by the State Drug Administration approved the listing, including Zhengda Qing fluorovirus group injection, Colum Pharmaceuticals Engli net, Huahai Pharmaceuticals ometantine hydrochloroquine tablets , acoustic pharmaceutical tofatisib, apocalyptic pharmaceutical thioic acid injection, garden pharmaceutical prostaline ammonia chloride tablets (I.), Puli pharmaceutical left ethyl laxitan injection with a strong solution and Chongqing drug friend toluene sulfonate soraphine tablets.
(National Drug Administration) Xinlitai "hydrochloric acid paroxetine intestinal dissolved release tablets" first imitation was approved on the 13th, Xinlitai 4 classes of generic drugs "hydrochloric acid paroxetine intestinal dissolved release tablets" approved by the State Drug Administration, successfully won the high-tech difficulty of intestinal dissolved release agent type first imitation.
is widely used clinically for various types of depressive disorders, such as obsessive compulsive disorder, generalized anxiety disorder, and social phobia.
(National Drug Administration) experimental SMA therapy by the FDA rare pediatric disease qualification Scholar announced on the 13th, the U.S. FDA has awarded its SRK-015 rare pediatric disease qualification (RPDD) for the treatment of spinal muscular dystrophy (SMA).
RPDD aims to promote the development of drugs and biologics for certain serious and life-threatening rare pediatric diseases and, more importantly, the company will be eligible for a priority review after the drug is approved for a new drug for this rare pediatric disease.
(Sina Pharmaceutical News) Kangfang BioPD-1/CTLA-4 dual resistance to FDA fast-track qualification 13, Kangfang Bio announced that its self-developed dual-specific antibody new drug PD-1/CTLA-4 (AK104) has been granted fast-track qualification by the U.S. FDA.
this is another significant development following the FDA's approval in April of a registered clinical study of AK104 monodratives for second-line treatment of relapsed or metastatic cervical cancer.
(Pharma Mission) Innovative Oral Lymphoma Therapy has been approved by the FDA for priority review TG Therapeutics announced that the FDA has accepted the company's application for a new drug for umbralisib, which is available to patients with treated marginal lymphoma (MZL) and treated with fig lymphoma.
Umbralisib is a daily oral PI3K and CK1-1-2 double inhibitor.
be granted priority review for MZL adaptation applications and is expected to receive a response by 5 February next year.
(Pharmaceutical Minder)