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[drug research and development 0403] FDA launches "coronavirus potential therapy accelerated approval plan". Rabbit emulsion source innovation hemophilia therapy has been approved by FDA.

2020-04-03 3891623

"This article consists of 16 pieces of information. The reading time is about 3 minutes."
Today's headlines
FDA launched "accelerated approval program for potential treatment of coronavirus". FDA announced an accelerated approval program (CTAP) for covid-19 potential therapies. The plan includes several initiatives, such as: after receiving the drug R & D request, the relevant FDA Staff will contact the R & D personnel within one day to help speed up the research process; the FDA will provide super fast and interactive information resources for most development plans, and determine the priority level of drug R & D; the FDA will provide super fast review within 24 hours after the R & D company submits the test plan; F Da will complete the single patient's request for extended use of specific drugs within 3 hours. In addition, to support the CTAP project, FDA will redeploy the work. FDA announced that at present, 10 kinds of therapies are in the stage of clinical verification and 15 kinds of therapies are in the stage of preparation for clinical trials.
Domestic drug information
1. Finasteride tablets of Chinese medicine passed the consistency evaluation. Finasteride tablets (5mg, 1mg) of Tianfang pharmaceutical, a subsidiary of China pharmaceutical, were approved by the State Food and Drug Administration and passed the consistency evaluation. Finasteride is a 5 α - reductase inhibitor. Its original drug was developed by Merck. Its market specifications are 5mg and 1mg. Among them, 5mg products are suitable for the treatment of existing symptoms of BPH in male patients with BPH. 1mg product is used to treat male alopecia (androgenic alopecia). Tianfang Pharmaceutical Co., Ltd. is the first enterprise that has passed the consistency evaluation of finasteride tablets with a specification of 1mg. In 2018, the sales volume of finasteride tablets in domestic sample hospitals was about 233 million yuan.
2. Indications for PD-1 urothelial carcinoma in Baiji Shenzhou will be approved soon. On March 30, the application for listing of tirelizumab injection for locally advanced or metastatic urothelial carcinoma (UC) that has been previously treated (cxss1900025) submitted by Baiji Shenzhou entered the stage of administrative approval and is expected to be approved in the near future. In a critical phase II clinical trial (ctr20170071), the median follow-up period was 8 months. Among 104 evaluable patients, the total remission rate of tirelizumab was 23.1%, including 8 patients with confirmed complete remission and 16 patients with confirmed partial remission. Safety and tolerability data are consistent with previous studies.
3. Bojian dimethyl fumarate enteric coated capsule is expected to be listed in China. On April 1, the listing application of dimethyl fumarate enteric coated capsule submitted by Biogen in China was included in the public list of priority review by the State Food and drug administration. Dimethyl fumarate was approved by FDA in March 2013 for the treatment of multiple sclerosis, and its trade name is tecfidera. Tecbidera is the third oral multiple sclerosis drug after fengomode and tertiazem, and it is the product with the highest sales volume of Biogen. In 2019, the global sales volume reached 4.433 billion US dollars, accounting for 31% of the total revenue of Biogen.
4. The listing application of linezolid was accepted. The listing application of linezolid glucose injection, a generic drug of Shisi pharmaceutical, was accepted by CDE. Linezolid, a synthetic oxazolidinone antibiotic, is mainly used to treat infections caused by Gram-positive bacteria. The original drug was developed by Pfizer, with global sales of 251 million US dollars in 2019. In China, the terminal sales of linezolid glucose injection in China's public medical institutions in 2018 was 1.515 billion yuan, and Zhengda Tianqing, Zhengda Fenghai and Haosen pharmaceutical industries have submitted supplementary application for conformity evaluation of the product.
5. The first patient of Baiji Shenzhou cooperative variety zw25 Ⅰ B / Ⅱ was administrated. The HER2 targeted bispecific antibody zw25 developed jointly by Baiji Shenzhou and zymeworks was administered to the first patient in a phase I B / II clinical trial. The two arm trial was designed to evaluate the efficacy of zw25 combined chemotherapy in the first-line treatment of patients with metastatic HER2 positive breast cancer, as well as the efficacy of zw25 combined chemotherapy and Baiji Shenzhou anti PD-1 antibody baizean? (tirelizumab injection) in the first-line treatment of patients with metastatic HER2 positive gastroesophageal adenocarcinoma (GEA). Under the partnership agreement, zymeworks will receive a payment for this milestone.
6. Taiji Group morphine hydrochloride sustained release tablets were approved for clinical use. The sustained-release morphine hydrochloride tablets (24h osmotic pump type) of Southwest Pharmaceutical Co., Ltd., a holding subsidiary of Taiji group, were approved by the State Food and drug administration. Morphine hydrochloride sustained-release tablets (24h osmotic pump type) are mainly suitable for the pain that other analgesic drugs are ineffective and need daily, continuous and long-term opioid analgesic treatment. At present, morphine hydrochloride sustained-release tablets (24h osmotic pump type) have not been approved for marketing in China. According to MI nei.com, in 2018, the total sales volume of morphine preparations in public hospitals in cities of China was about 237.88 million yuan.
International drug information
1. rabbit latex source innovation hemophilia therapy was approved by FDA. The FDA approved sevenfact, developed by LFB biotechnology, for the treatment and control of haemophilia A A or B in adults and adolescents over 12 years old. These patients had either clotting factor VIII or IX inhibitors (neutralizing antibodies). Sevenfact is a human coagulation factor VIIa analogue, derived from genetically engineered rabbit emulsion. Sevenfact is contraindicated in patients known to be allergic to rabbit or rabbit derived proteins. In one clinical study, for mild to moderate bleeding events, the success rate of the new drug treatment with lower dose (75 μ g / kg) and higher dose (225 μ g / kg) was about 86%.
2. The y-mabs antibody drug, naxitamab, was listed in the United States. Y-mabs announced that it has completed the rolling submission of gD2 targeted monoclonal antibody for the treatment of recurrent / refractory high-risk neuroblastoma in the United States. In a phase II 12-230 study (nct01757626), the objective remission rate (ORR) of children with primary and refractory high-risk neuroblastoma was 78%, and the progression free survival period of 50% of the patients was 24 months; the orr of children with recurrent neuroblastoma was 37%. This treatment scheme has significant clinical benefits in such refractory patients. Nexitamab has previously been awarded the orphan drug qualification by FDA for the treatment of neuroblastoma and osteosarcoma, as well as the breakthrough drug qualification, combined with GM-CSF for the treatment of high-risk neuroblastoma.
3. The latest test of grail cancer early screening technology is successful. Innovative blood testing methods developed by cancer early screening technology company grail have had positive results in a study called CCGA. Using this method, the researchers analyzed circulating cell-free DNA in 6689 blood samples, and found that the overall specificity of this method was 99.3%, and the sensitivity of all 50 I-III cancers was 43.9%; among 12 cancers with high mortality in the United States, this method could detect 2 / 3 of the early cancers in a timely manner; when cancer was detected, this method could correctly identify 90% %Above the cancer origin organ or tissue. The latest research was published in the journals of ESMO and JSMO.
4. Mesablast stem cell therapy is qualified for priority review. The biological product license application (BLA) of allogeneic cell therapy ryoncil (remestemcel-l) developed by mesoblast company was accepted by FDA for the treatment of steroid refractory acute graft-versus-host disease (sr-agvhd) in children. FDA also granted priority review qualification and is expected to respond by September 30. The results of a phase III trial showed that the orr of patients on the 28th day after ryoncil treatment was 69%, which was statistically significant compared with 45% of the historical data. In patients who received at least one infusion and were followed up for 100 days, the mortality rate was 22%. The 100 day mortality rate was 70% in patients who did not respond to initial steroid therapy.
5. Am Pharma completes a new round of financing. Am Pharma announced the completion of 163 million euros (about 176 million US dollars) financing to promote its innovative recombinant alkaline phosphatase (AP) treatment agent recap into phase III clinical trials, for the treatment of sepsis related acute renal injury (sa-aki) patients. In 2016, FDA has granted recap a fast track qualification for sa-aki treatment. In a phase II clinical trial, it has shown a significant improvement in renal function and reduced the mortality rate by more than 40%. In addition, the company is also exploring the efficacy of recap in inflammatory bowel disease (IBD) and hypophosphatasia (HPP).
Medical hotspots
1. Central finance: in 2019, the medical assistance subsidy reached 24.5 billion yuan. According to the report of statistics on the development of medical security in 2019 issued by the state health insurance bureau, in 2019, the central government invested 24.5 billion yuan in medical assistance subsidy, and arranged 4 billion yuan of subsidy to support the deep poverty areas to improve the medical insurance level of the poor; by the end of 2019, the comprehensive insurance policy for poverty alleviation by medical insurance benefited 200 million people and helped 4.18 million people who were poor due to illness Targeted poverty alleviation; in 2019, 77.82 million people will be subsidized to participate in basic medical insurance and 61.8 million people will be directly assisted; by the end of 2019, the coverage rate of the poor people who set up files and set up cards in rural areas will be over 99.9%.
2. Beijing: Qingming must be isolated at home for 14 days. Novel coronavirus pneumonia epidemic prevention and control work in Beijing, Chen Bei municipal government deputy secretary general said that Beijing's epidemic prevention and control is under the dual pressure of "external defense input and internal defense rebound", and the prevention and control measures must be strict. During the Qing and Ming Dynasties, after returning from the trip to Beijing, the relevant personnel must implement the measures and requirements of home isolation for 14 days. In addition, during the period of epidemic prevention and control, it will take 14 days for non local patients to come to Beijing for medical treatment.
3. Italy: no one in the largest Chinese community is infected with the new crown. So far, none of the 50000 Chinese in Prato, Italy's second largest city in Tuscany, has been infected with the new coronavirus, Reuters reported on April 1. Prato is the region with the largest density of Chinese in Italy and one of the largest Chinese communities in Europe. As of March 31, Italy has a total of 105792 confirmed cases and 12428 deaths, ranking the second in the number of confirmed cases and the first in the number of deaths in the world. But at the same time, the number of new confirmed cases in Italy is continuing to decline. Brusafero, President of the Italian Institute of higher health, also said that the growth curve of the epidemic in the country is flattening and the epidemic is entering a platform period.
4. Austria: people are forced to wear masks when entering supermarkets. Austria announced that people must wear masks when entering supermarkets from April 1. The government recognizes that wearing masks can slow down the spread of the new coronavirus in the air, with the aim of making it more common for people to wear masks in public places. Austria implements the "anti mask law", which originally stipulated that a doctor's certificate is required to wear a mask in public, and violators can be fined 150 euros. In addition, the Austrian government also cancelled the Easter holiday, and hotels and tourism will be completely closed during the Easter holiday.
Stock market information
Last trading day, A-share pharmaceutical sector + 1.09% up, top three down, top three North China Pharmaceutical + 7.79% Shuangcheng pharmaceutical - 3.13% Kangenbei + 5.84% Hengkang medical - 3.00% St Huiqiu + 5.00% Jincheng pharmaceutical - 2.77% [Hengrui pharmaceutical] Co., Ltd. recently received the approval document for supplementary drug application for capecitabine tablets approved and issued by the State Food and drug administration, which passed the consistency evaluation of quality and efficacy of generic drugs.
[Tongrentang] (1) in 2019, the operating revenue was 13.277 billion yuan (- 6.56%), the net profit attributable to the parent was 985 million yuan (- 13.12%), and the net profit not attributable to the parent was 924 million yuan (- 7.74%). (2) The annual report - Q4 growth rate is (- 13.12%) - (- 52.44%), and the deduction rate is (- 7.74%) - (- 50.18%). (3) Feng Zhimei no longer holds the post of chief accountant due to job transfer, resigning from the company's directors, members of the audit committee of the board of directors and directors

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