Once known as "the hope of the people", ridceway has brought a lot of hope recently. Recently, redcivir was authorized by FDA to expand the treatment scope to people under 12 years old, and was conditionally recommended by who to treat non severe covid-19 patients with high risk of hospitalization. At the same time, many enterprises are accelerating the research and development of oral version of redcivir. Vv116, which has made the fastest progress, launched the head-to-head phase III trial with Pfizer paxlovid in early April, and will start clinical trials in Hong Kong.
During the new release cycle from April 22 to April 28, Zhejiang Jingxin Pharmaceutical Co.Ltd(002020) of class 1 new drug andacini capsule was reported for production, becoming the company's first small molecule innovative drug to apply for listing; 12 innovative drug projects from stone Pharmaceutical Group, Hansen pharmaceutical and gakos were approved clinically for the first time, and we included them in the "people's finance · innovative drug index".
In terms of clinical progress, skb264, a new trop2 ADC drug of Sichuan Kelun Pharmaceutical Co.Ltd(002422) and fb2001, a covid-19 small molecule drug of Frontier Biotechnologies Inc(688221) are about to start clinical registration. Driven by these factors, the "people's finance · innovative drug index" Rose 0.74% to 2619 points in the new release cycle.
oral redcivir accelerated development
On April 25, the US Food and Drug Administration (FDA) expanded the scope of application of veklury to include children who are 28 days and older, weigh at least 3kg and have covid-19 virus positive results. This means that redcivir has become the first anti covid-19 therapy approved for children under the age of 12. Previously, redcivir has been approved for the treatment of hospitalized covid-19 patients aged 12 and over and weighing at least 40 kg.
Recently, the efficacy of redcivir has been recognized by who. In the "therapy and covid-19: dynamic guidelines" updated on April 21, who conditionally recommended redcivir for the treatment of non severe covid-19 patients with high risk of hospitalization. Previously, the who did not recommend the use of redcivir for any degree of covid-19 inpatients, and even once said it was almost ineffective.
In this regard, Gilead said that the update of WHO guidelines recognized the important role of redcivir in helping high-risk groups of covid-19 disease progression. However, at present, it has not fully reflected the evidence of the wide effectiveness of redcivir for patients with different degrees as other treatment guidelines around the world.
According to Gilead, redcivir has been recommended by a number of important guidelines in more than 40 countries and regions around the world for the treatment of mild, moderate and severe covid-19 patients. At present, more than half of patients hospitalized for covid-19 in the United States are treated with redcivir. Redcivir and its generic drugs have benefited 11 million patients worldwide, including 7 million patients from 127 low - and middle-income countries and regions.
To some extent, redciway is indeed "the hope of the people". In terms of effectiveness, redcivir is close to Pfizer oral paxlovid The pinetree study, published by Gilead on April 24, showed that patients treated with redcivir within five days of symptom onset had a 90% lower risk of hospitalization; The risk of hospitalization was reduced by 81% in patients treated with redcivir five days after the onset of symptoms. At the same time, in vitro laboratory tests of several independent studies showed that redcivir showed persistent activity against the continuously mutated sars-cov2, including Omicron variant and its subtype variant ba 1 and ba 2。
However, the disadvantages of redcivir are also obvious. The compliance of intravenous injection is worse than that of oral medicine, which is undoubtedly an important factor affecting the accessibility of redcivir.
Therefore, it is necessary to develop improved drugs that can be taken orally and have better curative effect. At present, many pharmaceutical companies have started the research and development of oral version of redcivir, including Gilead, Shanghai Junshi Biosciences Co.Ltd(688180) , Shan Dong Kexing Bioproducts Co.Ltd(688136) , etc.
Among them, Shanghai Junshi Biosciences Co.Ltd(688180) the vv116 cooperated with Wangshan wangshui is the oral deuterated version of redcivir, and an international multicenter phase III clinical study is being carried out for patients with mild, moderate and severe covid-19 pneumonia.
On April 28, according to the website of the Chinese University of Hong Kong, vv116 will start clinical trials in Hong Kong. This study will recruit 2000 recently diagnosed covid-19 patients aged 18 or above, which is the first large-scale clinical study of covid-19 oral medicine in Hong Kong. In the view of insiders, the progress of vv116's mild to moderate international multicenter phase III clinical trial was slow. After announcing the start of clinical trial in Hong Kong, the enrollment of subjects is expected to accelerate.
Meanwhile, vv116 is conducting head-to-head test with Pfizer paxlovid in Shanghai. According to our understanding, in addition to the normal phase III clinical trial, led by academician Ning Guang, vv116 is conducting head-to-head trials with Pfizer paxlovid in Shanghai Ruijin Hospital, public health center and Pudong hospital, mainly for mild to moderate covid-19 patients. In this trial, the scale of subjects is 800. The administration will be completed at the end of April, followed by 14 and 28 days of observation. If the effect is not worse than Pfizer paxlovid, it will directly apply for emergency use authorization.
As the original formulation of redcivir, Gilead also started the research and development of oral version of redcivir. At present, Gilead is developing a prodrug of redcivir called gs-5245, which can be quickly converted into redcivir in vivo. Gilead website shows that gs-5245 is in phase I clinical stage.
Similar to vv116, Shan Dong Kexing Bioproducts Co.Ltd(688136) the covid-19 oral drug shen26 cooperated with aetnavir is also an improved version of redcivir. It is reported that the activity of shen26 is 4.7 times that of redcivir, and it is currently in the stage of preclinical research Shan Dong Kexing Bioproducts Co.Ltd(688136) 4 on April 28, the company said on the investor interaction platform that the company plans to carry out phase II / III international multicenter research after the completion of phase I clinical study of shen26.
Zhejiang Jingxin Pharmaceutical Co.Ltd(002020) first class 1 new drug production report
On April 24, Zhejiang Jingxin Pharmaceutical Co.Ltd(002020) of class 1 new drug andacini capsule (R & D Code: evt201) was declared on the market for the treatment of insomnia. This is Zhejiang Jingxin Pharmaceutical Co.Ltd(002020) 's first application for the listing of small molecule innovative drugs, marking the milestone progress of the company's innovative drug research and development.
It is reported that andacini capsule is a partial positive allosteric regulator of GABAA receptor, which selectively acts on GABAA receptor α Subtype 1, which shows high affinity and moderate intensity of excitement, can induce rapid sleep and maintain sleep.
The company completed the phase III clinical trial of the drug in November 2021, reached the primary endpoint and secondary endpoint, and submitted the listing application to the drug administration in March 2022.
Previously, the main endpoint results of the randomized, double-blind, placebo-controlled, multicenter phase 3 clinical study of andacini capsule in the treatment of insomnia reached the pre-set excellence and efficacy standard. The results show that andacini capsule can significantly prolong the total sleep time of insomnia patients.
At present, the treatment drugs for insomnia mainly include benzodiazepines such as diazepam and clonazepam, as well as new non benzodiazepines represented by zolpidem (listed in China in 1995) and right zopiclone (listed in China in 2007). Since then, no new drugs have been approved for marketing in China.
Zhejiang Jingxin Pharmaceutical Co.Ltd(002020) said in the annual report that after evt201 capsule is approved for listing, it will enrich the CNS pipeline innovative drug products, improve the competitiveness in core fields and promote the innovation and transformation of Jingxin.
12 innovative drug projects were approved for clinical use for the first time
In the new release cycle, 12 innovative drug projects from stone Pharmaceutical Group, Hansen pharmaceutical and gakos were approved clinically for the first time, including 8 chemical drugs and 4 biological drugs.
Among them, syhx2005 of Shiyao group and jab-6343 capsule of jiakesi belong to highly selective FGFR4 (fibroblast growth factor receptor 4) inhibitors, which were approved on the 24th and 26th respectively.
It is reported that FGFR is one of the hot targets of "unlimited cancer" therapy, and is attracting more and more pharmaceutical enterprises. In terms of highly selective FGFR4 and pathway, there are no FGFR4 inhibitors on the market at present, and there are only a few candidate drugs in different clinical development stages in the world. The FGFR4 inhibitors under research in China include icp-105 of nuocheng Jianhua, Zhejiang Hisun Pharmaceutical Co.Ltd(600267) hs236, Betta Pharmaceuticals Co.Ltd(300558) bpi-43487 and sy-4798 of Shouyao holding. At present, these projects are in clinical phase I.
Gc101 til of Junsai biology and gt101 injection of gravel biology are til (tumor infiltrating lymphocyte) therapy. The front and rear feet of the two new drug projects have been approved for clinical application.
Til cell therapy separates and enriches tumor killer cells from fresh tumor tissues. After functional repair and scale expansion in vitro, til cell therapy plays an anti-tumor effect by intravenous reinfusion into patients. Til cell therapy has shown a high proportion and long-lasting objective palliative effect on many types of advanced solid tumors. It is considered to be one of the most potential solid tumor therapies. At present, China's til cell therapy is heating up. In addition to the til cell therapy of Junsai biology and gravel biology approved for clinical use in China, the til treatment products of Jinfeng biology have been approved by the U.S. FDA to enter clinical phase I in February this year.
In terms of clinical progress, on April 26, Sichuan Kelun Pharmaceutical Co.Ltd(002422) at ClinicalTrials The phase III clinical trial of the new drug skb264 of trop2 ADC in the treatment of triple negative breast cancer was registered on the website of www.tropica.gov. This means that skb264 has become the first domestic trop2-adc to enter the registered clinic On April 27, Frontier Biotechnologies Inc(688221) announced that its covid-19 small molecule drug fb2001 was approved to carry out phase II / III international multicenter clinical trial, and fb2001 plans to carry out phase II / III international multicenter clinical trial. (Zhilan)
