[March 24, 2021 / Medical Information List] China's first RET inhibitor was approved; Biotech re-submitted the H-share listing application to the Hong Kong Stock Exchange.
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Part1 Policy BriefPart1 policy briefing Part1 policy briefing
Fosun make it back from today to suspend the notification of new vaccine inoculation crown mRNA Macau complexFosun Pharma responds to Macau's suspension of vaccinations of COVID-19 vaccine from today
On March 24, Fosun Pharma issued an announcement in which it responded to the news that "mRNA Covid-19 vaccine is covered with related defects, and Hong Kong and Macao regions will suspend vaccination today.
" The reply stated that for product safety considerations, BioNTech and the Group have initiated an investigation into the cause of the problem, and on March 24, 2021, the relevant authorities in Hong Kong and Macau have notified the relevant authorities in Hong Kong and Macau to suspend the vaccination batch number "210102" Of the vaccine until the end of the investigation.
In addition, out of prudence, the vaccine product with the batch number "210104" for supply to Hong Kong, China will also be sealed and will not be sent to all vaccination points until further notice.
(Fosun Pharmaceutical Announcement)
The State Food and Drug Administration Revises the Instructions for Mouse Nerve Growth Factor for InjectionThe State Food and Drug Administration Revises the Instructions for Mouse Nerve Growth Factor for Injection
On March 23, the State Food and Drug Administration issued an announcement on the revision of the instructions for mouse nerve growth factor for injection, and decided to revise the instructions for mouse nerve growth factor for injection [adverse reactions], [precautions] and medications for special populations.
Among them, the [Precautions] emphasizes the addition of "Should strictly follow the usage and dosage prescribed in the instructions.
It is strictly forbidden to change the route of administration.
" (National Food and Drug Administration)
Part2 ObservationPart2 Sankei Observation Part2 Sankei Observation
Biotech: Resubmit the H-share listing application to the Hong Kong Stock ExchangeBiotech: Resubmit the H-share listing application to the Hong Kong Stock Exchange
On March 23, Biotech announced that the company is in the process of applying for the public issuance of overseas listed foreign shares (H shares) and listing on the main board of the Hong Kong Stock Exchange.
The company has resubmitted an application for the issuance and listing to the Hong Kong Stock Exchange on March 23, and published the application materials for the issuance and listing on the website of the Hong Kong Stock Exchange on the evening of March 23.
CICC is the sole sponsor.
Sino Biopharmaceutical acquires a company for US$110 millionSino Biopharmaceutical acquires a company for US$110 million
Yesterday, China Biopharmaceuticals announced a new acquisition while releasing its annual report.
Its subsidiary, C-Lab International Limited, entered into an agreement to acquire 100% SOFTHALE NV (Softhale) at a price of US$110 million + additional payments related to regulatory and commercial milestones to expand the respiratory pipeline.
Part3 Medicine NewsPart3 Medicine News Part3 Medicine News
Disclosure of Phase III Clinical Results of Hausen's Class 1 New Drug "Imitenofovir"Disclosure of Phase III Clinical Results of Hausen's Class 1 New Drug "Imitenofovir"
Recently, according to the Insight database, the first round of supplementary information for Hausen Pharmaceutical's Class 1 new drug "Imitenofovir Tablets" has been submitted.
The industry predicts that the drug is expected to be approved in the first half of the year at the earliest.
Emitenofovir tablets are a class 1 new drug independently developed by Hansen Pharmaceuticals, which is a new type of nucleotide reverse transcriptase inhibitor.
Novartis Targeted Radiation Therapy Reaches Phase 3 Clinical EndpointNovartis Targeted Radiation Therapy Reaches Phase 3 Clinical Endpoint
On March 23, Novartis announced that its potential "first-in-class" targeted radioligand therapy 177Lu-PSMA-617 has reached the dual primary endpoint in a phase 3 clinical trial for the treatment of patients with advanced prostate cancer.
Compared with the best standard treatment, 177Lu-PSMA-617 significantly improved the overall survival and radiological progression-free survival of patients with metastatic castration-resistant prostate cancer.
Daiichi Sankyo mRNA vaccine DS-5670 Phase I/II clinical trial in Japan begins immunizationDaiichi Sankyo mRNA vaccine DS-5670 Phase I/II clinical trial in Japan begins immunization
Recently, Daiichi Sankyo Pharmaceutical announced that the Phase I/II clinical trial of the novel coronavirus pneumonia (COVID-19) mRNA vaccine (DS-5670) in Japan has begun to vaccinate subjects.
It is understood that the synthesis and production process of mRNA vaccines is relatively convenient and has strong immunogenicity.
Pfizer said an oral new crown treatment drug has entered clinical trialsPfizer said an oral new crown treatment drug has entered clinical trials
On March 24th, 23rd local time in the United States, the pharmaceutical company Pfizer announced on its official website that the oral new crown treatment drug PF-07321332 has entered the phase 1b clinical trial phase.
This is the world's first oral new crown treatment drug to enter clinical trials.
Pfizer said that in vitro studies conducted so far have shown that PF-07321332 is a protease inhibitor that can effectively combat the activity of the new coronavirus.
At present, a phase I clinical trial has been conducted in the United States to give the drug to healthy adults to evaluate the safety and tolerability of the drug.
(Associated Finance Press)
Arikayce, a drug for the treatment of nontuberculous mycobacterial lung disease caused by MAC, was approved in JapanArikayce, a drug for the treatment of nontuberculous mycobacterial lung disease caused by MAC, was approved in Japan
Recently, Insmed announced that the Ministry of Health, Labour and Welfare of Japan has approved Arikayce for the treatment of patients with nontuberculous mycobacterial pulmonary infections caused by Mycobacterium avium complex (MAC) who have insufficiently responded to previous multi-drug regimens.
It is expected to be launched in Japan in the middle of this year.
FDA approves Zegalogue injection to treat diabetic patients with severe hypoglycemiaFDA approves Zegalogue injection to treat diabetic patients with severe hypoglycemia
A few days ago, Zealand Pharma announced that the US FDA has approved Zegalogue injection for the treatment of severe hypoglycemia in children and adult diabetic patients 6 years and older.
The FDA approved Zegalogue based on the efficacy results of three randomized, double-blind, placebo-controlled, multicenter Phase 3 studies in children and adults with type 1 diabetes between 6 and 17 years of age.
The test results showed that compared with placebo, the patient's blood glucose recovery rate was faster after Zegalogue administration.
(Sina Pharmaceutical News)
Galite FASN inhibitor TVB-2640 obtained FDA fast track qualificationGalite FASN inhibitor TVB-2640 obtained FDA fast track qualification
On March 23, Gallée issued a press release stating that its partner, Sagimet Biosciences, announced that the fatty acid synthase inhibitor TVB-2640 has obtained U.
FDA Fast Track designation for non-alcoholic steatohepatitis indications.
China's first RET inhibitor, Cornerstone Pharmaceuticals, pratinib approvedChina's first RET inhibitor, Cornerstone Pharmaceuticals, pratinib approved
CStone Pharmaceuticals announced today that NMPA has approved the marketing application of pratinib capsules for the treatment of locally advanced or metastatic non-small cell lung cancer patients who have previously received platinum-containing chemotherapy for the treatment of adult patients with positive transfection rearrangement gene fusion.
(Sina Pharmaceutical News)
CanSino Bio-Inhalation Recombinant Novel Coronavirus Vaccine Approved for Clinical ClinicCanSino Bio-Inhalation Recombinant Novel Coronavirus Vaccine Approved for Clinical Clinic
On March 23, CanSino Bio announced on the Hong Kong Stock Exchange that the company cooperated with the Institute of Biological Engineering of the Academy of Military Sciences of the Chinese People’s Liberation Army on March 22 to develop a recombinant new coronavirus vaccine for inhalation (adenovirus type 5).
Carrier) has obtained NMPA drug clinical trial approval.
It is reported that the vaccine is the first approved adenovirus vector new crown vaccine in China.
(Cansino Biological Announcement)
Recombinant new coronavirus fusion protein vaccine, a subsidiary of Joincare Pharmaceuticals, has been approved for clinical useRecombinant new coronavirus fusion protein vaccine, a subsidiary of Joincare Pharmaceuticals, has been approved for clinical use
On March 24, Joincare Pharmaceuticals issued an announcement stating that the clinical trial application for the "recombinant new coronavirus fusion protein vaccine" developed by its holding subsidiary Livzumab was approved by the State Food and Drug Administration.
The indication is to prevent new coronavirus infections.
The disease caused by.
(Announcement of Health Yuan Pharmaceutical)
Ganli Pharmaceutical's GZR18 clinical application was accepted by NMPAGanli Pharmaceutical's GZR18 clinical application was accepted by NMPA
On March 23, Ganli Pharmaceuticals issued an announcement that its clinical application for GZR18, a category 1 innovative therapeutic biological product under development, was accepted by the NMPA, and the application indications were type II diabetes, obesity and overweight.
(Announcement from Gan Li Pharmaceutical)
Kelun Pharmaceutical obtained the drug registration certificate for sunitinib malate capsulesKelun Pharmaceutical obtained the drug registration certificate for sunitinib malate capsules
On March 24, Kelun Pharmaceutical issued an announcement that its subsidiary Hunan Kelun Pharmaceutical recently obtained the "Drug Registration Certificate" for the chemical drug "Sunitinib Malate Capsules" approved and issued by the National Medical Products Administration.
It is understood that the drug is used for inoperable advanced renal cell carcinoma, imatinib mesylate treatment failure or intolerable gastrointestinal stromal tumor and unresectable metastatic well-differentiated advanced pancreatic neuroendocrine tumor.
(Kelun Pharmaceutical Announcement)
Biotech: Adalimumab injection obtained approval for drug supplement applicationBiotech: Adalimumab injection obtained approval for drug supplement application
On the 24th, Biotech announced that it had recently received the "Drug Supplement Application Approval Notice" for Adalimumab injection approved and issued by the State Food and Drug Administration.
The drug was approved for new indications and new specifications: polyarticular juvenile idiopathic arthritis.
Janssen's new RSV fusion protein inhibitor plans to be included in breakthrough treatment varietiesJanssen's new RSV fusion protein inhibitor plans to be included in breakthrough treatment varieties
According to the latest announcement on the website of the Drug Evaluation Center of the State Drug Administration, the JNJ-53718678 oral suspension developed by Johnson & Johnson's Janssen company is intended to be included in the breakthrough treatment product.
The proposed indication is: treatment of moderate to severe respiratory infections caused by respiratory syncytial virus in children .
Conba: 1mg finasteride tablets passed the consistency evaluation of generic drugsConba: 1mg finasteride tablets passed the consistency evaluation of generic drugs
On March 24, Kang Enbei announced that recently, Hangzhou Kang Enbei, a wholly-owned subsidiary of the company, has received the "Drug Supplementary Application Approval Notice" issued by the State Drug Administration for 1 mg finasteride tablets.
The approval conclusion is that the product has passed the generic drug quality and efficacy consistency evaluation.
1mg finasteride tablets are mainly used to treat male baldness (androgenic alopecia).
Yiling Pharmaceutical Dextromethorphan Hydrobromide Tablets Passed the Consistency EvaluationYiling Pharmaceutical Dextromethorphan Hydrobromide Tablets Passed the Consistency Evaluation
On March 24, Yiling Pharmaceutical announced that it received the "Drug Supplementary Application Approval Notice" for dextromethorphan hydrobromide tablets approved and issued by the National Medical Products Administration.
The drug passed the generic drug quality and efficacy consistency evaluation.
Dextromethorphan hydrobromide tablets are a central antitussive used for dry coughs, including coughs caused by upper respiratory tract infections (such as colds and pharyngitis), bronchitis, etc.
(Announcement from Yiling Pharmaceutical)
Osaikang Pharmaceutical Paricalcitol Injection Enters the Administrative Approval StageOsaikang Pharmaceutical Paricalcitol Injection Enters the Administrative Approval Stage
Recently, Jiangsu Aosaikang Pharmaceutical has entered the administrative examination and approval stage with the imitation of Paricalcitol injection in Category 6 and is expected to be approved in the near future.
Data show that paricalcitol is the latest generation of selective vitamin D receptor agonists, which can effectively reduce parathyroid hormone in combination with vitamin D receptors, and is used to treat secondary hemodialysis patients with chronic renal failure Hyperparathyroidism.