In February 17th, Joincare Pharmaceutical Group Industry Co.Ltd(600380) (600380.SH) announced that the recombinant New Coronavirus fusion protein vaccine V-01 (hereinafter referred to as V-01), a subsidiary of the company holding subsidiary Livzon Pharmaceutical Group Inc(000513) (000513.SZ), Zhuhai Li Zhu mAb Biotechnology Co., Ltd. (hereinafter referred to as “Li Zhu mAb”) has completed the interim main data analysis of the phase III clinical trial.
According to the analysis results of the present analysis, the annual incidence rate of V-01 sequential enhancement group and two needle inactivated vaccine group were 6.73% and 12.80%, respectively, after V-01 sequential enhancement compared with two needle inactivated vaccine (P=0.0012). The absolute protective force of v-01 after sequential strengthening is 61.35%, which has significant strong and excellent effect, and has met the WHO standard.
Since the outbreak of covid-19 epidemic, there has been fierce competition in vaccine Market Research and development. At present, dozens of covid-19 vaccines have been approved for marketing or authorized for emergency use around the world. At the same time, more than 100 covid-19 vaccines are in clinical trials. What is the expected return of v-01 after it is approved for listing in the future? In an interview with the media including the daily economic news on the afternoon of February 18, Zhu Baoguo, chairman of Joincare Pharmaceutical Group Industry Co.Ltd(600380) and Livzon Pharmaceutical Group Inc(000513) said that at present, v-01 has submitted listing application materials to the State Food and Drug Administration and hopes to be approved for listing in multiple overseas markets in the future, but it is difficult to measure the future income with specific figures.
complete the sequential strengthening phase III interim analysis
It is understood that v-01 has been approved and developed since July 2020. It is an innovative covid-19 recombinant protein vaccine developed by lizumab in cooperation with the Institute of Biophysics, Chinese Academy of Sciences. V-01 was approved by the State Food and Drug Administration for clinical trial in early 2021. The phase II clinical trial data of two doses of v-01 showed that the vaccine had excellent immunogenicity and safety. Especially in the elderly group, the overall incidence of vaccine related adverse events was lower than that of the corresponding adult group.
Overseas, v-01 has been approved to conduct phase III clinical trials of sequential strengthening scheme in Pakistan and Malaysia. The company said that up to now, the cumulative R & D cost of lizuzumab in v-01 project is about 509 million yuan.
The so-called sequential immunization refers to the use of vaccines with different technical routes from basic immunization for enhanced immunization. Taking covid-19 vaccine as an example, if two doses of inactivated vaccine have been completed previously, and other non inactivated route vaccines are used for subsequent booster injections, that is, sequential booster immunization.
Compared with placebo, sequential v-01 vaccine has stronger protective effect than placebo. According to the company, v-01 has carried out phase III clinical trials in Pakistan and Malaysia. It plans to inject v-01 booster needle or blank placebo 1:1 among 10722 healthy adults aged 18 and over who have completed two doses of inactivated vaccine for 3-6 months.
The company’s analysis showed that the annual incidence rate of V-01 sequential enhancement group and two needle inactivated vaccine group were 6.73% and 12.80%, respectively, after V-01 sequential enhancement compared with two pin inactivated vaccine (P=0.0012). The absolute protective force of v-01 after sequential strengthening is 61.35%, which has significant strong and excellent effect, and has met the WHO standard. The company further said that the sequential strengthening of v-01 can produce good protection against covid-19 caused by Omicron infection, and no safety problems worthy of attention were found.
what is the expected market prospect?
Since the outbreak of covid-19, there has been fierce competition in vaccine Market Research and development. Joincare Pharmaceutical Group Industry Co.Ltd(600380) according to the information of LSHTM tracker, as of February 7, 2022, a total of 121 covid-19 vaccine products around the world were in clinical trials, of which 27 products had been approved for marketing or authorized for emergency use; China has obtained conditional approval for listing 4 products (products without recombinant protein technology route), obtained emergency use approval for 7 products (including 1 recombinant protein technology route), and a total of 21 products are in clinical trial stage (8 recombinant protein technology routes).
Does the v-01 under Joincare Pharmaceutical Group Industry Co.Ltd(600380) seem a little late? In an interview with the media including the daily economic news on the afternoon of February 18, Joincare Pharmaceutical Group Industry Co.Ltd(600380) and Livzon Pharmaceutical Group Inc(000513) chairman Zhu Baoguo said that in terms of listing time, it may have some impact on the final market share of v-01; However, in terms of application effect, the clinical trial data of v-01 is better, and it is in the first echelon of vaccines all over the world.
With dozens of covid-19 vaccines approved for marketing or authorized for emergency use around the world, what are the expected future benefits of v-01? In this regard, Zhu Baoguo said, “of course, we hope that the vaccine can be listed in all markets. The drug approval of each country has its own laws and regulations. We will apply for emergency use authorization or listing application.”
Zhu Baoguo also said that the income of v-01 after listing cannot be measured by specific figures. “As long as the vaccine can be useful for epidemic prevention and control, I think the income to the society is greater than that of our enterprise itself.”
