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As the State Food and Drug Administration conditionally approved Henan Real Bio Azfuding tablets, the registration application for the treatment of new coronavirus pneumonia has increased, and the trend of the new coronavirus oral medicine track has continued to increase.
htmlOn October 10, listed company Geli Pharmaceutical issued an announcement stating that its new crown oral polymerase (RdRp) inhibitor ASC10 has increased in multiple doses. Phase I clinical trials were in the National Infectious Disease Medical Center, First Affiliated Hospital of Zhejiang University School of Medicine, completed the first three cohorts of 24 healthy subjects.The day before, the listed company Guangshengtang also announced that its holding subsidiary Fujian Guangsheng Zhonglin Biotechnology Co., Ltd. (hereinafter referred to as "Guangsheng Zhonglin") was successfully admitted to the first innovative drug GST-HG171 tablets Phase I clinical trial of its holding subsidiary Fujian Guangsheng Zhonglin Biotechnology Co., Ltd. (hereinafter referred to as "Guangsheng Zhonglin") and the first innovator drug GST-HG171 tablet was successfully admitted to the group and administered on October 3, 2022.
Beijing News Shell Finance reporter saw on the official website of the China Clinical Trial Registration Center that as of June 25, there have been 955 clinical studies on the new coronavirus pneumonia in my country, involving diagnosis, prevention, treatment, post-currence, research, mental health, etc. Whether it is research and development, experiments or strategic cooperation with , COVID-19 therapeutic drugs have become a high ground for competition.
htmlOn October 10, the stock market market fell, and the new crown drug sector was down as a whole. Judging from the closing situation, among the 47 listed companies in the new crown drug sector, Junshi Biologics , Minova , Haite Biologics , Ruizhi Pharmaceuticals, Fosun Pharmaceuticals and other stocks ranked among the top, while 11 stocks including Xinhua Pharmaceuticals , Xilong Science, and Tuoxin Pharmaceuticals rose.and the two companies disclosed clinical progress, saying that can fight Omickron variant
After the National Day holiday, Guangshengtang and Geli Pharmaceutical both disclosed the latest clinical progress of their new crown oral drugs.
According to the announcement of Geli Pharmaceutical, a multi-dose escalation phase I clinical trial of the oral RdRp inhibitor ASC10 of the new crown new crown will be enrolled in 72 healthy subjects, including 60 subjects in the 6 dose escalation cohort and 12 subjects in the food impact trial. Enrollment is expected to be completed in the fourth quarter of 2022.
"This trial was double-blind and placebo-controlled to evaluate the safety, tolerance and pharmacokinetics (PK) of ASC10 tablets. The remaining 12 subjects will receive two single doses of 800 mg ASC10 tablets (postprandial or fasting) to assess the PK effect of food on ASC10 in healthy subjects," said Glee Pharmaceuticals.
It is understood that ASC10 is an oral double prodrug. After oral administration, both ASC10 and monoprodrug monupivir can quickly and completely convert into the same active metabolite ASC10-A in vivo. ASC10-A has broad-spectrum antiviral activity against the most widely spread Omickron variants such as BA.5 and novel variants BA.2.75.
According to the announcement of Guangshengtang on October 9, the first subject of the first phase I clinical trial of the first innovative drug GST-HG171 tablet of Phase I clinical trial of Guangsheng Zhonglin, a subsidiary of Innovation Drug Holdings, oral small molecule broad-spectrum anti-novel coronavirus 3CL protease inhibitor, was successfully admitted to the group and administered on October 3.
Guangshengtang said that GST-HG171 is a highly active and highly selective oral 3CL protease inhibitor. It has excellent antiviral efficacy and safety in preclinical studies, and has broad-spectrum anti-coronavirus activity. It has high viral inhibitory activity on the original strain of the new coronavirus, Omickron BA.4, BA.5 variants, and beta and delta variants. Based on preclinical in vitro and in vivo experimental data, GST-HG171 has excellent efficacy, safety, and lung tissue distribution characteristics, and is expected to become a leading 3CL protease inhibitor.
html opened on October 10, and the stock price of of Geli Pharmaceutical Hong Kong stock fell, with a closing price of HK$2.52; Guangshengtang's stock price rose after the opening, with the highest transaction price of RMB31.78 per share, closing price of RMB430.7, and increased by 0.43%. On October 11, Guangshengtang's stock price fell by 2.67%, while Geli Pharmaceutical's Hong Kong stock price fell by 4.76%. Two new coronavirus treatment drugs,, have been approved, and the annual self-production capacity of real biologics is expected to increase to 3 billion tablets
, Shell Finance reporters learned that there are currently two new coronavirus treatment drugs approved in my country: imported drugs Pfizer Nematvir tablets/ritonavir tablets and domestic Henan Real Bio Azfu Ding tablets.
At present, Azvdin has been included in the COVID-19 "Diagnosis and Treatment Plan" and is also included in medical insurance payment. Compared with the new coronavirus treatment drugs launched on the market, Azfuding tablets have a greater price advantage. According to the price of medical insurance online in various places, Azfu’s pre-order tablets are priced at 270 yuan per bottle, 35 tablets per bottle, and 1 mg per tablet.
In February this year, the State Food and Drug Administration issued an announcement that in accordance with the special drug approval procedures, the import registration of Pfizer's new coronavirus treatment drug Nematvir tablets/ritonavir tablets (i.e. Paxlovid) was approved with conditions. This drug is an oral small molecule novel coronavirus treatment drug, which is used to treat adult patients with mild to moderate novel coronavirus pneumonia who have progressed to severe high-risk factors, such as patients with severe high-risk factors such as chronic renal disease, diabetes , cardiovascular disease, chronic lung disease, etc.
In February this year, the State Food and Drug Administration approved the import registration of Pfizer's new coronavirus treatment drug Nematvir tablets/ritonavir tablets combination packaging.
:00 to July this year, the State Food and Drug Administration conducted emergency review and approval in accordance with the special drug approval procedures, and approved the registration application for the increase in indications for the treatment of new coronavirus pneumonia with conditions. This is currently the only approved oral small molecule treatment drug for new coronavirus pneumonia in my country, which can be used to treat adult patients with ordinary novel coronavirus pneumonia.
Azvdine is a nucleoside analog that inhibits viral RNA-dependent RNA polymerase (RdRp). It specifically acts on the new coronavirus RdRp to achieve the purpose of inhibiting viral replication. In July 2021, Azvdin has obtained conditional approval for conjunction with other reverse transcriptase inhibitor to treat adult HIV-infected patients with high viral load. This time, it was approved as a conditional approval for a new indication.
According to clinical experimental data, Azvdin showed good therapeutic effects on mild, moderate and severe patients with COVID-19 at a daily dose of 5 mg per person, and the half-life in target cells exceeds 120 hours.
It is worth mentioning that after the real bio's Azfuding tablets increased the indications for the treatment of new coronavirus pneumonia, the relevant concept stock was also pushed to the forefront. Among them, China Resources Shuanghe, Fosun Pharma and others have announced that they have cooperation with Henan Real Bio. Real Bio and Fosun Pharma's subsidiary reached a strategic cooperation agreement on the joint development of Azfuding and the exclusive commercialization of Fosun Pharma's industry.
It is understood that Zhen Bio has signed strategic agreements with many domestic pharmaceutical manufacturing companies to produce and supply Azfuding APIs and tablets. From the existing self-production capacity, the annual production capacity of Azfu tablets is about one billion tablets.
In addition, according to the hearing materials submitted by Real Bio to the Hong Kong Stock Exchange in early August, the company currently has a production line designed for Azfuding, and plans to build another production line to expand its manufacturing capacity and meet expected market demand. "We expect to increase the total planned annual production capacity to about 3 billion tablets of Azfuding through these two production lines."
compete for the R&D highland: Many listed companies have joined the
Shell Finance reporter saw on the official website of the China Clinical Trial Registration Center that as of June 25, there have been 955 clinical research projects in my country (of which 51 clinical research projects have been withdrawn), involving diagnosis, prevention, treatment, post-currence, research, mental health, etc.
As of the end of 2021, a list of oral drugs for the new crown that have been on the market or are undergoing phase III clinical practice worldwide.
Since the outbreak of the new crown pneumonia epidemic, my country has continuously invested drugs in treatment.
Shell Finance reporter noticed that on September 26, China Biopharma also announced that its subsidiary Beijing Ted Pharmaceuticals independently developed the Class I innovative drug "TDI01" was approved by the State Drug Administration on September 23 to carry out clinical trials of the new coronavirus pneumonia.
China Biopharmaceuticals said that TDI01 is the world's first small molecule innovative drug to inhibit the invasion of the new coronavirus on host cells by highly selectively inhibiting the ROCK2 kinase, thereby achieving a significant impact on the new coronavirus.
In addition, on August 10, listed company Qianjie Bio said that its Phase I clinical trial of FB2001 for the injection of small molecule anti-coronavirus drugs was conducted in the United States and China. A total of 120 subjects received intravenous injection of FB2001. "Data from the Phase I clinical trials in the United States and China show that FB2001 has good clinical safety and tolerance, no dose-limiting toxicity (DLT), no serious adverse event reports were found, plasma drug concentration and simulated lung drug concentration can reach the effective drug concentration level for treatment, and there is no race difference between the pharmacokinetic characteristics in the United States and the Chinese population."
In addition, FB2001, a research product of Frontier Biotech, is an anti-COVID-19 3CL protease inhibitor, and has launched an international multicenter Phase II/III clinical trial. In May this year, the first clinical study of subjects in Junshi Bio's new crown oral drug VV116 was released.
also faces international brand competition for the new crown oral drugs of real bio.
According to the prospectus of Real Biology, as of December 31, 2021, about 50 companies around the world have advanced the antiviral candidates for treating COVID-19 to the clinical development stage.
Real Bio said in the launch hearing material that it is expected that competitive products in the field of COVID-19 treatment will include Merck -approved monapiravir developed by FDA, remdesivir developed by Gilead Sciences and Paxlovid developed by Pfizer .
At present, in addition to Paxlovid developed by Pfizer, it has obtained conditional approval in my country. On September 28, Sinopharm Group and Merck signed a cooperation framework agreement. Merck granted the distributor rights and exclusive import rights of the anti-new coronavirus oral drug Monoravir in China under its cooperation with Ridgeback to Sinopharm Group China Biologics. At the same time, both parties will evaluate the feasibility of technology transfer so that the drug can be produced, supplied and commercialized in China.
According to information disclosed by Merck China, monoravir is an oral small molecule treatment drug for the new coronavirus. Globally, Monoravir has obtained marketing authorization or emergency use authorization in more than 40 countries or regions including the United States, EU , Australia, Japan, South Korea, Hong Kong, and Taiwan. As of the end of August 2022, Merck has supplied more than 8.6 million courses of monoravir to more than 30 markets around the world, treating more than 1.8 million patients.
Beijing News Shell Finance Reporter Li Yunqi Editor Wang Jinyu Proofreading Liu Baoqing
