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Yuan Dong, Ted...The siege surged by 300% injections! Osaikon is here too
Time of Update: 2021-04-27
0 Chinese Drug Evaluation Database In recent years, with the efforts of domestic pharmaceutical companies, AbbVie's paricalcitol injection market share has declined rapidly, from its monopoly in 2017 to less than 20% in the first half of 2020.
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East Asia Pharmaceuticals: Subsidiary cefaclor API passed Japan PMDA GMP certification
Time of Update: 2021-04-27
) GMP written inspection, the inspection scope covers the quality, production, equipment and facilities, laboratory control, materials and other systems of cefaclor API.
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.
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Haisco's "Avanafil Tablets" Approved for Listing
Time of Update: 2021-04-27
Yesterday, the official website of the State Food and Drug Administration showed that the avanafil tablets declared by Haisco according to registration classification 3 (domestic applicants imitated the overseas listing but the original research was not listed in the domestic market) have been approved for marketing by NMPA (approval number: National Medicine Standard H20213212 , Sinopharm Zhunzi H20213213), it will be the first imitation of this product after it is marketed.
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Where is the next leap in CAR-T therapy? Cinda Bio and other Chinese companies explore new directions
Time of Update: 2021-04-27
According to the official website of Reindeer Medical, for patients with relapsed/refractory multiple myeloma, high-dose BCMA targeted CAR-T cell therapy may provide better remission, but the adverse events are more serious.
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Hengrui SHR6390 plans to be included in the breakthrough therapy CDK4/6 inhibitor melee is about to start
Time of Update: 2021-04-27
The proposed indication is SHR6390 tablets combined with fulvestrant to treat hormone receptors that have progressed after endocrine therapy ( HR) positive, human epidermal growth factor receptor 2 (HER2) negative recurrent or metastatic breast cancer, the publication date ends on March 24.
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Fined 18,000 yuan for producing and selling inferior drugs
Time of Update: 2021-04-27
Liaoning New Century Pharmaceuticals was rectified within a time limit due to three issues including the inconsistency between the actual storage conditions of some traditional Chinese medicinal materials and the regulations.
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Recombinant new coronavirus fusion protein vaccine, a subsidiary of Joincare Pharmaceuticals, has been approved for clinical use
Time of Update: 2021-04-27
On March 24, Joincare Pharmaceuticals issued an announcement stating that the clinical trial application of the "recombinant new coronavirus fusion protein vaccine" developed by its holding subsidiary Livzumab was approved by the State Food and Drug Administration.
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Huahai Pharmaceutical's voriconazole for injection was approved for clinical use
Time of Update: 2021-04-27
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.
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AstraZeneca/Mersk’s Lynparza combined with Roche Avastin is recommended in the UK for the treatment of ovarian cancer
Time of Update: 2021-04-27
), used for maintenance treatment of patients with homologous recombination defect (HRD) positive advanced ovarian, fallopian tube and peritoneal cancer that fully or partially respond to first-line platinum-based chemotherapy and bevacizumab.
The US FDA approved the drug for use in advanced ovarian cancer with germline BRCA mutation (gBRCAm) that has received three or more chemotherapies.
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Conba: 1mg finasteride tablets passed the consistency evaluation of generic drugs
Time of Update: 2021-04-27
The sales of 1mg finasteride in the medical terminal market in 2019 was 47.
In 2019, the sales revenue of Hangzhou Kangenbei 1mg finasteride tablets was RMB 2.
73 million in research and development for the consistency evaluation of 1 mg finasteride tablets.
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National Health Commission: The key configuration of these medical equipment
Time of Update: 2021-04-27
" The meeting requested that relevant departments in various regions should earnestly implement the spirit of the Central Deep Reform Commission meeting and the deployment requirements of the State Council, start with standardizing the behavior of medical subjects, increase the supervision and management of the behavior of medical institutions and medical staff, strengthen technological innovation, promote resource sharing, and make overall plans.
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Mobile phone follow-up visits, mobile phone prescriptions...Internet medical treatment makes it easier to see a doctor
Time of Update: 2021-04-27
Mobile phone follow-up, simple and quick operation Online follow-up consultation saves time and money for patients and their families, saves patients from the pain of boats and cars, and is conducive to postoperative recovery "Hello, Director Chen, I have some cough, what's the matter?" "The feeding tube is placed in the throat, which will cause irritation.
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Daiichi Sankyo mRNA vaccine DS-5670 Phase I/II clinical trial in Japan begins immunization
Time of Update: 2021-04-27
Recently, Daiichi Sankyo 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.
Just recently, Moderna announced that its new-generation vaccine mRNA-1283 has been immunized in the first phase of clinical trials for the first batch of subjects.
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Hengrui Medicine: Docetaxel injection passed the quality and efficacy consistency evaluation of generic drugs
Time of Update: 2021-04-27
On March 25, Hengrui Pharmaceutical announced that the company's docetaxel injection passed the quality and efficacy consistency evaluation of generic drugs.
The company's docetaxel injection has been approved by the US FDA in 2017, and the ANDA numbers are 203170 and 207252 respectively.
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Renfu Medicine: Mifepristone tablets passed the consistency evaluation of generic drugs
Time of Update: 2021-04-27
, a subsidiary of the company, received the "Drug Supplementary Application Approval Notice" from the State Food and Drug Administration on mifepristone tablets (notice Book number: 2020B05143), the drug passed the generic drug quality and efficacy consistency evaluation.
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Shanghai passed local legislation: Chinese medicine is included in public health emergency management system
Time of Update: 2021-04-27
Encourage pharmaceutical manufacturers, operators of Chinese medicinal materials and Chinese medicinal pieces, medical institutions, and industry associations to establish an information traceability system in accordance with relevant laws, regulations and technical standards.
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Hisun Pharmaceutical: Epirubicin Hydrochloride for Injection passed the consistency evaluation of generic drugs
Time of Update: 2021-04-27
On March 23, Hisun Pharmaceutical announced that the company's epirubicin hydrochloride for injection has passed the quality and efficacy consistency evaluation of generic drugs.
On May 5, 2019, the State Food and Drug Administration accepted the company's application for the consistency evaluation of epirubicin hydrochloride for injection.
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Fuan Pharmaceutical: Cefminox sodium for injection passed the consistency evaluation
Time of Update: 2021-04-27
, has recently received a supplementary drug application approval notice issued by the National Medical Products Administration, and its product Cefminox sodium for injection has passed The quality and efficacy consistency evaluation of generic drugs.
Cefminox sodium for injection is an anti-infective drug.
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Roche's PD-L1 antibody Tecentriq in the Phase 3 clinical trial of NSCLC patients reached the primary endpoint
Time of Update: 2021-04-27
On March 22, Genentech, a subsidiary of Roche, announced that its PD-L1 antibody Tecentriq (atezolizumab, atelizumab) will be used for the treatment of early stage non-small cell lung cancer (NSCLC) patients in Phase 3 clinical trials.
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Jinling Pharmaceutical's ferrous succinate tablets obtained the consistency evaluation of the National Food and Drug Administration
Time of Update: 2021-04-27
On March 23, Jinling Pharmaceutical issued an announcement stating that the branch Jinling Pharmaceutical Factory had recently received a notice of acceptance of the consistency evaluation of ferrous succinate tablets issued by the State Food and Drug Administration.
Jinling Pharmaceutical Factory first obtained the Drug Registration Approval for this product in 2002.
