On April 6, Kintor Pharma announced the Phase III clinical trial of proclutamide in the treatment of non-hospitalized COVID-19 patients with mild to moderate illnessKey data results of the trial: Prokalutamide can effectively reduce hospitalization/mortality; can improve new crown-related symptoms. Affected by this news, Hong Kong shares of Kintor Pharmaceuticals (9939.HK) soared 200% within 2 minutes of opening.
high-risk COVID-19 patients 100% protection rate span>
Efficacy data from this clinical trial show that proclutamide is effective in reducing hospitalization/mortality. Among all subjects randomized and taking the drug for at least 1 day (N=730), the number of hospitalization events in the control group and the prokalutamide group were 8 (including one death) and 4 (no death), respectively. The corresponding protection The rate was 50% (all subjects were hospitalized due to COVID-19); among subjects who completed taking the drug for more than 1 day (N=721), the number of hospitalization events in the control group and the proclutamide group were 7 (including 7 cases). 1 death) and 2 cases (no deaths), corresponding protection rate was 71%; among subjects who completed medication for more than 7 days (N=693), control The number of hospitalization events in the group and the proclutamide group were 6 cases (including one death) and 0 cases (p<0.02), respectively, and the corresponding protection rate was 100%. Prokalutamide also significantly reduced hospitalization/mortality in subjects with high risk factors (especially in the middle-to-high age group), with a corresponding protection rate of 100%.
In addition, compared with the control group, from the 3rd day to the 28th day of administration, the prokalutamide treatment group, Significant and sustained reduction of SARS-CoV-2 virus load (day 3 and day 28, p<0.01). In terms of symptom improvement, the proclutamide group also improved some of the related symptoms of new coronary pneumonia better than the control group, such as fever, shortness of breath, cough, and the improvement continued to be better than the control group until at least the 28th day.
According to the safety data, the overall tolerance of prokluamide in the treatment of patients with mild to moderate COVID-19 is good and safe and controllable. Across the trial, adverse event rates were 7.9% in the control group and 9.6% in the prokalutamide group, most of which were mild, with the most common adverse event being dizziness (the control group). The incidence of any other adverse event was less than 1%. No serious adverse events occurred during the study.
Interim analysis failed, yet another village?
Although today’s Kintor is “proud”, just a few months ago, the company suffered from “waterfall”, The announcement stated that the interim analysis of the Phase III clinical trial of Prokluamide did not reach statistical significance. At that time, the industry generally believed that the Phase III clinical trial of Prolutamide had failed.
Affected by this news at that time, Kintor Pharmaceutical’s stock price plummeted by more than 80% at the opening, and its market value evaporated nearly 10 billion Hong Kong dollars, and it returned to before liberation. Not only the stock market of Pioneer Pharmaceuticals plummeted, but Fosun Pharma, which loves investment, also lays down its guns silently.
Last July, Fosun Pharma saw the prospect of proclutamide for the new crown, and joined the investment and cooperation with Kintor with great interest.
In news, on July 15 last year, Kintor Pharma and Fosun Pharma reached a cooperation on the commercialization of proclutamide for the treatment of COVID-19 in India and 28 African countries According to the agreement, the two parties will cooperate with each other to jointly promote the application, promotion and sales of the emergency use authorization (EUA) for the new crown indications of proclutamide.
According to the terms of the agreement, Fosun Pharma Industry will obtain the exclusive rights to register and commercialize proclutamide in the cooperation area, and pay Kintor Pharmaceuticals no more than RMB 5.6 RMB 100 million, including down payment, development milestones of approximately RMB 110 million, and commercialization milestones not exceeding RMB 450 million.
In addition, Kintor will charge not less than 50% of the total profit as sales commission based on the future net sales of Prokluamide in the cooperation area.
The result of Kintor’s research on proclutamide was “broken”, but it made Fosun Pharma feel sad. Is it possible to usher in the dark and bright now? We would like to bless Kintor Pharma and Fosun Pharma. After all, Kintor Pharma has had zero turnover in the past 3 years, and there is not much time left for Kintor in the market.
Interim Analysis Results of a Phase III Clinical Trial of ProkalutamideAfter coming out, Xu Jianqing, a distinguished professor of Fudan University, said in an interview with a reporter from the International Finance News, “From my understanding of the mechanism of the drug, I think the drug will be helpful for severe cases, but for severe cases. Mild-moderate disease may have a moderate effect.The reason is: the anti-inflammatory effect of the drug is relatively precise, but the anti-virus effect is difficult to be precise. Because of the diversity of receptors of the new coronavirus, It is not necessarily required that ACE2 and TMPRSS2, such as AXL, MyH9, KREMEN1 and ASGR1, can be used as receptors for the new crown.”
In fact, from the announcement of the interim analysis results of proclutamide It can be seen that Kintor also acquiesced to the failure of the Phase III clinical trial to a certain extent, and plans to revise the clinical trial protocol to recruit only high-risk patients with COVID-19. However, the results of the effective trial of proclutamide announced this time are still aimed at non-hospitalized patients with mild to moderate symptoms. We can’t help but wonder whether Kintor Pharmaceuticals has reached effective communication with the FDA. This clinical trial was conducted in the FDA. carried out with the tacit consent of the Can the test results be approved by the FDA?
History is always strikingly similar? Oral new crown drugs make waves again
From the failure of the interim analysis to the sudden announcement of success, this style is a little familiar.
On June 7, 2021, the FDA granted accelerated approval to Biogen’s new Alzheimer’s drug Aduhelm. However, as early as March 2019, Biogen and Eisai announced the early termination of two global phase III clinical trials of Aducanumab code-named ENGAGE and EMERGE, because after a comprehensive analysis of the data, it was believed that Aducanumab was effective in AD or EMERGE. There is no improvement in mild cognitive impairment caused by mild AD, and it is likely to be difficult to reach the primary efficacy endpoint; however, in October of the same year, the two companies announced that they would submit a biological product licensing application for aducanumab to the FDA in early 2020 ( BLA) and will continue to negotiate with regulators in Europe, Japan and other regions.
This wave of operations is astounding, and Biogen’s reason for applying for BLA is that they include more high-dose subjects and complete them for a longer period of time (78). Weeks), the results of the analysis changed, and the expected data were obtained in one of the trials (EMERGE). Aducanumab can be brought back to life, and people in the industry are tacitly aware that biostatisticians really have the superpower of rejuvenation. G. Caleb Alexander, a member of the FDA advisory committee and an epidemiologist and expert on drug safety and efficacy, believes that the company uses post-mortem analysis to interpret the data, like the Texas sharpshooter fallacy, which is “shoot first, then draw the target.” In the end, we also know that the FDA ignored the strong opposition of the independent expert advisory committee(a number of experts later resigned because of this, they believed that the FDA’s insistence hurt their professionalism) span>, the drug was approved for marketing.
However, in the subsequent clinical application, according to relevant reports, doctors in many hospitals refused to use the drug, and on December 20, 2021, Biogen announced that it would be ready for use. The price of the controversial Alzheimer’s drug Aduhelm was cut in half, from $56,000 to $28,000.
Review of Past Issues>>Bojian-Aducanumab encountered Waterloo, and AD drugs in China and the United States staged a “two layers of ice and fire”
This time The diametrically opposed mid-term and final trial results of Prokluamide are so similar to Aduhelm, is it still clinical statistics at play, and can it finally be approved like Aduhelm? There are also opinions in the industry that although the results of this trial look beautiful, they are still not convincing from a statistical point of view and have not reached the primary endpoint. At present, Kintor has been actively applying for EUA licenses for emergency medication from national drug regulatory agencies in China, the United States and other countries and regions. We will follow up on the final result.
postscript
I don’t know since when, pharmaceutical R&D has become so closely related to the stock market. There is a strange tacit understanding under the combination of the 10-year research and development process and the stock market that is changing every second. Although the stock market reflects people’s expectations for the future, are people’s expectations too uncertain? However, in the final analysis, the market is still not confident in the original innovative power of domestic innovative pharmaceutical companies, and Most Biotech companies are not profitable and cannot prove their value through performance in the short term, which leads to the market easily ignoring the fundamentals of companies and panicking Sexually thrown. But there is no doubt that Chinese biomedicine has accumulated a lot of experience in the blood, sweat and tears of its predecessors, and the research and development of innovative drugs has been accumulating from quantitative changes.Qualitative change is no longer completely crossing the river by feeling the stones. It is believed that with the ingenuity of the Chinese people, China’s innovative drugs will soon achieve qualitative changes.
Cilta-cel is the first CAR-T therapy approved by the FDA in China, according to Dr. Fan Xiaohu, co-founder of Nanjing Legend , where the company was founded, in the face of the industry’s popular CD19 target, they did not choose to enter the market directly, but conducted in-depth research in the market, and finally chose the multiple myeloma patient group. There is no shortcut to success, especially in pharmaceutical innovation, where the time cost is clear. Work hard at the initial stage of R&D project establishment, not only to consider the unmet clinical needs, but also to consider the survival status of the patient population. Including age, gender, economic income, etc., we also need to consider the future competition pattern.After all, there are so many targets for effective verification, and everyone is a discerning person. Innovative drug companies need to give full play to the power of flexible innovation, grasp the differentiated clinical value of products, and ultimately rely on corporate innovation and super marketing power to win. There are not many examples of domestic original research innovations, but there are already many companies’ drugs going overseas through license-out cooperation, indicating that the domestic drug research and development strength has gradually been recognized by the international market. It is believed that with the passage of time and the deepening of the supply-side reform of new drug research and development, there will be more successful examples of innovative drugs going overseas. Chinese pharmaceutical companies are also moving towards world-class pharmaceutical companies, and the future is worth looking forward to.
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