[March 25, 2021 / Medical Information List] Hengrui Medicine anticancer drugs through assessment; East Sunshine entacapone tablets granted; India found new variation of the double mutant virus .
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Part1 Policy BriefPart1 policy briefing Part1 policy briefing
India discovers double mutation new mutated new coronavirusIndia discovers double mutation new mutated new coronavirus
On March 25th, 24th local time, the Ministry of Health of India issued a statement stating that a new variant of the new coronavirus has been discovered in the state of Maharashtra.
The strain has double mutations, which may weaken the immune effect.
And it is more contagious.
The Ministry of Health also said that it has not been possible to determine whether the strain is related to the surge in the number of confirmed cases in Maharashtra and other regions.
(Associated Finance Press)
The group purchase of medical consumables will reduce the price of coronary dilatation balloons by 90%The group purchase of medical consumables will reduce the price of coronary dilatation balloons by 90%
On March 25, after the price of coronary stents was greatly reduced through centralized procurement, the price of coronary dilatation balloons, which are also necessary for coronary artery-related treatment, remained high.
To this end, the Beijing-Tianjin-Hebei "3+N" alliance "group purchase" coronary dilatation balloons.
A total of 72 products were selected for this purchase, and the price dropped from an average price of 3401 yuan to 319 yuan, an average price reduction of 90%.
In the first year, the number of intended purchases reached 315,000, which is expected to save 942 million yuan.
(Associated Finance Press)
A pharmaceutical company fined 10,000 yuan for producing and selling unqualified pharmaceutical packaging materialsA pharmaceutical company fined 10,000 yuan for producing and selling unqualified pharmaceutical packaging materials
On March 24, the Shandong Provincial Food and Drug Administration issued a notice on the administrative penalty information announcement of Shandong Shipuler Bio-Pharmaceutical Co.
The notice pointed out that the “non-volatile matter” item of the high-density polyethylene bottle for oral liquid medicinal use produced by the company did not meet the standard requirements.
In accordance with relevant laws and regulations, the company supervised and handled the batch of illegal products, and the company imposed a fine of 10,000 yuan.
(Shandong Drug Administration)
Part2 ObservationPart2 Sankei Observation Part2 Sankei Observation
AbbVie accused competitor of stealing Xiumile trade secretsAbbVie accused competitor of stealing Xiumile trade secrets
On March 24, according to foreign media reports, AbbVie alleged in a new lawsuit filed in Illinois that Alvotech recruited its former manufacturing executive Rongzan Ho, with the purpose of stealing secrets manufactured by Xiu Mei Le.
The complaint alleges that after Rongzan Ho joined Alvotech, he was responsible for the production of biosimilars in the company.
(Sina Pharmaceutical News)
Bojian refuses sympathetic use of experimental ALS drugsBojian refuses sympathetic use of experimental ALS drugs
Recently, nearly 70,000 people signed a petition online, asking Biogen to provide an experimental amyotrophic lateral sclerosis (ALS) drug to a patient, but the pharmaceutical company decided not to provide treatment.
The core reason for Biogen's refusal to use the drug is that it is understood to be used by more patients in the future to ensure the fairness of the research conducted by subjects randomized to receive placebo treatment.
(Sina Pharmaceutical News)
Hutchison Pharmaceuticals sells non-core non-prescription drug joint ventures for US$169 millionHutchison Pharmaceuticals sells non-core non-prescription drug joint ventures for US$169 million
On March 24, Hutchison Medicine announced that it had reached a US$169 million transaction agreement with GL Mountrose Investment Two Limited, which is controlled and managed by Telford Capital.
Hutchison Medicine stated that it would sell its indirect holdings of non-core and non-consolidated assets.
100% equity in Baiyunshan and Huang Zhongyao, an over-the-counter drug joint venture.
(Official Weibo of Hutchison Medicine)
Jingli Technology completes nearly 30 million U.
dollars in Series B financing
dollars in Series B financing
Recently, Jingli Technology, a leading private domain industry solution service provider in the country, announced the completion of nearly US$30 million in Series B financing.
This round of financing was led by Trust Capital, and the old shareholders Jingwei China and Shunwei Capital continued to follow up with the investment, and Yibai Capital served as the exclusive financial advisor for this round.
ImmuneOnco completes US$89 million Series C financingImmuneOnco completes US$89 million Series C financing
On March 24, ImmuneOnco announced the completion of a $89 million Series C financing.
The financing was jointly led by the Greater Bay Area Fund and Eli Lilly Asia Fund, with the Shanghai Science and Technology Innovation Fund co-leading the investment, Pre-A round investor Zhang Ke led and B round investor LYFE Capital continued to invest more.
Eli Lilly Asia Fund and LYFE Capital continued to invest in additional investments.
Xin Nuopu Medical receives nearly 60 million U.
dollars in Series G financing
dollars in Series G financing
Artery Network was informed for the first time that Synopsys Medical recently completed nearly US$60 million in Series G financing.
The lead investor is Huagai Capital, Yuansheng Ventures and the old shareholder SIG followed up, and Haoyue Capital served as the exclusive financing for this round of financing.
Part3 Medicine NewsPart3 Medicine News Part3 Medicine News
Clover Biology and Dynavax announced that the global Phase II/III clinical trial of the new crown vaccine candidate has completed the first volunteer vaccinationClover Biology and Dynavax announced that the global Phase II/III clinical trial of the new crown vaccine candidate has completed the first volunteer vaccination
Recently, Clover Biology and Dynavax jointly announced that Clover Biology’s new crown vaccine candidate global phase II/III clinical trial project “SPECTRA” has completed the first batch of volunteer inoculations.
The clinical trial is designed to evaluate Clover Biology’s “S-trimer” recombinant protein subunits.
The effectiveness, safety and immunogenicity of unit new crown candidate vaccines in combination with Dynavax's CpG 1018 plus aluminum adjuvant.
The world's first contact lens approved to treat eye allergies is hereThe world's first contact lens approved to treat eye allergies is here
Today, Johnson & Johnson Vision, a subsidiary of Johnson & Johnson, announced that Japan’s Ministry of Health, Labour and Welfare has approved the company’s drug-releasing contact lens Acuvue Theravision.
This contact lens contains ketotifen, an antihistamine that can treat itchy eyes associated with eye allergies.
It is understood that this is the world's first drug release contact lens approved by regulatory agencies for marketing.
East Asia Pharmaceuticals: Subsidiary cefaclor API passed Japan PMDA GMP certificationEast Asia Pharmaceuticals: Subsidiary cefaclor API passed Japan PMDA GMP certification
On March 25, East Asia Pharmaceuticals announced that its subsidiary Toho Pharmaceuticals had accepted Japanese PMDA’s GMP written inspection on September 14, 2020.
The inspection scope covers the quality, production, equipment and facilities, and laboratories of cefaclor raw materials.
Control, material and other systems.
On March 24, 2021, Toho Pharmaceutical received the "Notification of Drug Suitability Survey Results" issued by PMDA, confirming that Toho Pharmaceutical's cefaclor API passed the Japanese GMP certification.
(Announcement from East Asia Pharmaceuticals)
Boehringer Ingelheim's new drug BI 425809 for schizophrenia received clinical approvalBoehringer Ingelheim's new drug BI 425809 for schizophrenia received clinical approval
On March 24, the official website of CDE showed that Boehringer Ingelheim's new drug BI 425809 has been approved for clinical use by default and is intended to be used to treat cognitive symptoms of schizophrenia.
Huahai Pharmaceutical's voriconazole for injection was approved for clinical useHuahai Pharmaceutical's voriconazole for injection was approved for clinical use
On March 25, Huahai Pharmaceutical issued an announcement stating that it had recently received the "Notice of Drug Clinical Trial Approval" for voriconazole for injection issued by the State Food and Drug Administration.
Voriconazole for injection is a broad-spectrum triazole antifungal drug; the original research company is Pfizer, which was approved for domestic marketing in October 2004.
(Huahai Pharmaceutical Announcement)
Haisco's "Avanafil Tablets" Approved for ListingHaisco's "Avanafil Tablets" Approved for Listing
Yesterday, the official website of the State Food and Drug Administration showed that the avanafil tablets declared by Haisco according to registration classification 3 have been approved by the NMPA and will be the first imitation of this variety after listing.
It is reported that the drug is mainly used to treat erectile dysfunction, with specifications of 100mg/tablet and 200mg/tablet.
Dongyang Sunshine's "Entacapone Film" Approved for ListingDongyang Sunshine's "Entacapone Film" Approved for Listing
Recently, the official website of the State Food and Drug Administration showed that the entacapone tablets declared by Dongyang according to registration classification 4 have been approved by the NMPA for marketing.
At present, this variety is only marketed in China by the original research, and it will be the first imitation variety after it is approved for marketing.
The drug is used to treat Parkinson's disease and end-of-dose phenomenon (fluctuations in symptoms) that cannot be controlled by the above drugs.
Renhe Pharmaceuticals Entecavir Tablets Obtained Drug Registration CertificateRenhe Pharmaceuticals Entecavir Tablets Obtained Drug Registration Certificate
On March 25, Renhe Pharmaceutical announced that its subsidiary Jiangxi Pharmaceutical has recently received the "Drug Registration Certificate" for Entecavir tablets approved and issued by the State Drug Administration.
It is reported that entecavir tablets are mainly suitable for the treatment of chronic adult hepatitis B with active virus replication, continuous increase in serum alanine aminotransferase or liver histology showing active lesions.
(Announcement of Renhe Medicine)
Renfu Medicine: Mifepristone tablets passed the consistency evaluation of generic drugsRenfu Medicine: Mifepristone tablets passed the consistency evaluation of generic drugs
On March 25, Renfu Pharmaceutical announced that recently, Hubei Gedian Renfu Pharmaceutical, a holding subsidiary, received the "Drug Supplementary Application Approval Notice" from the State Food and Drug Administration on mifepristone tablets.
The drug passed the quality of generic drugs.
And evaluation of consistency of efficacy.
It is reported that mifepristone tablets are currently widely used pregnancy termination drugs.
(Announcement of Renfu Medicine)
Review of Hengrui Medicine Docetaxel InjectionReview of Hengrui Medicine Docetaxel Injection
On March 25, Hengrui Pharmaceuticals announced that the company's docetaxel injection passed the quality and efficacy consistency evaluation of generic drugs.
Docetaxel is a paclitaxel anti-tumor drug, which plays an anti-tumor effect by interfering with the microtubule network necessary for cell mitosis and interphase cell function.
(Announcement of Hengrui Medicine)
Two injections of Sichuan Creed Pharmaceuticals continue to enter administrative approvalTwo injections of Sichuan Creed Pharmaceuticals continue to enter administrative approval
Recently, the Sodium Valproate Injection and Micuronium Chloride Injection, which were reported for production by Sichuan Creed Pharmaceuticals under the new registration classification, have entered the administrative examination and approval stage.
At present, no generic drugs have been approved for the listing of these two products in China.
Micuronium chloride belongs to the benzyl isoquinoline compound.
It can be used as an auxiliary medicine for general anesthesia to relax skeletal muscles and facilitate tracheal intubation and mechanical ventilation.
Eastern Sunshine Herbal Escitalopram oxalate tablets will be approved soonEastern Sunshine Herbal Escitalopram oxalate tablets will be approved soon
Recently, Dongyang Sun Pharmaceutical has entered the administrative approval stage with the imitation of escitalopram oxalate tablets reported for production in category 4, and is expected to become the company's second antidepressant approved for marketing.
The drug is clinically used to treat depression, panic disorder with or without agoraphobia.
Guizhou Bailing: Ruikang Hospital received approval for registration of preparations from medical institutionsGuizhou Bailing: Ruikang Hospital received approval for registration of preparations from medical institutions
On March 25, Guizhou Bailing announced that the company signed a "Technology Development (Cooperation) Contract" with Ruikang Hospital on January 5, 2018.
The two parties intend to jointly participate in the research and development of the medical institution preparation "Tangning Tongluo Capsule" project .
Ruikang Hospital recently received the "Approval for Registration of Preparations for Medical Institutions" issued by the Drug Administration of Guangxi Zhuang Autonomous Region.
(Guizhou Bailing Announcement)