Suggestive announcement of key data of phase III clinical trial of Joincare Pharmaceutical Group Industry Co.Ltd(600380) Pharmaceutical Group
Stock Code: 600380 Stock Name: Joincare Pharmaceutical Group Industry Co.Ltd(600380) Announcement No.: pro 2022-017 Joincare Pharmaceutical Group Industry Co.Ltd(600380) about
Recombinant New Coronavirus fusion protein vaccine to enhance critical data bulletin announcements in phase III clinical trials
The board of directors and all directors of the company guarantee that there are no false records, misleading statements or major omissions in the contents of this announcement, and bear individual and joint liabilities for the authenticity, accuracy and completeness of its contents.
Important content tips:
Recently, the recombinant New Coronavirus fusion protein vaccine developed by Li Zhu monoclonal antibody (hereinafter referred to as: V-)
01) the interim master data analysis of sequential phase III clinical trials has been completed and key data have been obtained.
The vaccine R & D cycle is long, and v-01 needs to continue to complete phase III clinical trials. The progress and results of vaccine R & D clinical trials are affected by the test scheme, subject recruitment, epidemic development and other factors, and there is uncertainty.
According to the current national regulations on vaccine registration and management, v-01 can only be put on the market after completing phase III clinical research, comprehensive review, production site verification and other procedures. Whether v-01 can obtain the marketing approval of the corresponding drug regulatory authority and the time of obtaining the marketing approval are still uncertain.
The sales situation of the vaccine after its listing is affected by many factors such as epidemic development, market environment and sales channels, and the subsequent market sales situation of the vaccine is uncertain. According to the vaccination situation, the epidemic prevention effect and adverse reactions may be affected by individual differences.
V-01 is developed by lizumab in cooperation with the Institute of Biophysics, Chinese Academy of Sciences. The intellectual property rights formed in the process of R & D and the income or income formed after listing and sales comply with relevant agreements or contracts. Zhuhai lizuzumab Biotechnology Co., Ltd., a holding subsidiary of Livzon Pharmaceutical Group Inc(000513) (hereinafter referred to as: Livzon Pharmaceutical Group Inc(000513) ) of Joincare Pharmaceutical Group Industry Co.Ltd(600380) (hereinafter referred to as the company)
Suggestive announcement of key data of phase III clinical trial of Joincare Pharmaceutical Group Industry Co.Ltd(600380) Pharmaceutical Group
The recombinant New Coronavirus fusion protein vaccine, developed by the company (hereinafter referred to as Li Zhu mAb), has completed the interim master data analysis of the phase III phase III clinical trials and has obtained key data. The relevant details are hereby announced as follows: I. Basic information of drug research and development
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 China National Drug Administration for clinical trials in early 2021, and indications for prevention of New Coronavirus infection (COVID-19). V-01 molecule is composed of interferon, pan epitope, RBD dimer and Fc fusion protein. Human interferon as a biological adjuvant is fused into the antigen structure, which significantly enhances the level of virus neutralizing antibody and produces an effective cellular response. The phase II clinical trial data of v-01 two shot vaccination was published in Chinese medical journal in July 2021. The test results show that the vaccine has excellent immunogenicity and safety. Especially in the elderly group, the overall incidence of vaccine related adverse events is lower than that in the corresponding adult group.
In October 2021, Li Zhu monoclonal antibody first obtained the Pakistan Drug Administration’s international multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial on the evaluation of the protective efficacy, safety and immunogenicity of the recombinant New Coronavirus fusion protein vaccine (V-01), which was sequentially enhanced in the completion of the 2 inactivated vaccine inoculation for healthy adults over 18 years of age and above. (see below: sequential Enhancement Plan) approval. For more details, please refer to the ” Joincare Pharmaceutical Group Industry Co.Ltd(600380) reminder” on the progress of the clinical trial of recombinant New Coronavirus fusion protein vaccine released in October 27, 2021 (pro 2021-131), and subsequently obtained the approval of clinical trials of the sequential Enhancement Plan in Malaysia to speed up the research.
Up to now, the cumulative direct R & D cost of lizumab in v-01 project is about 509.409 million yuan (including the costs related to phase I / II clinical trial, sequential enhancement and phase III clinical trial of basic immunity).
2、 Key data and conclusions of sequential enhanced phase III clinical trial
This sequential strengthening scheme is a sequential strengthening design based on two doses of inactivated vaccine, which adopts the standard of strong relative protection and excellent effect, which is different from the control of traditional blank placebo scheme. V-01 has carried out a phase III clinical trial of sequential intensification in Pakistan and Malaysia. It is planned 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.
As of the date of this critical data analysis, 10241 people were actually enrolled, and a total of 110 primary endpoint cases were monitored after vaccination (the scheme requires at least 103 primary endpoint cases to be analyzed). According to the analysis of the present stage, the results showed that the annual incidence rate of V-01 sequential enhancement and two needle inactivated vaccine was 6.73% and 12.80%, respectively, with significant difference between the V-01 sequential and two needle inactivated vaccine groups (P=0.0012). V-01 sequence
Suggestive announcement of key data of phase III clinical trial of Joincare Pharmaceutical Group Industry Co.Ltd(600380) Pharmaceutical Group
The absolute protective force after penetration strengthening is 61.35%, which has significant strong and excellent effect. V-01 sequential strengthening of absolute protection has met who standards. The genotyping and first-generation sequencing of covid-19 virus in 60 of all valid samples submitted for examination in this test are Omicron (the rest are still undergoing second-generation sequencing), indicating that the sequential strengthening of v-01 can produce good protection against covid-19 caused by Omicron infection. At the same time, no safety problems worthy of attention were found. 3、 Market situation of drugs
According to LSHTM tracker information, 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 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).
4、 Risk tips
1. The vaccine R & D cycle is long, and v-01 needs to continue to complete phase III clinical trials. The progress and results of vaccine R & D clinical trials are affected by the test scheme, subject recruitment, epidemic development and other factors, and there is uncertainty. 2. According to the current national regulations on vaccine registration and management, v-01 can only be put on the market after completing phase III clinical research, comprehensive review, production site verification and other procedures. Whether v-01 can obtain the marketing approval of the corresponding drug regulatory authority and the time of obtaining the marketing approval are still uncertain.
3. The sales situation of the vaccine after its listing is affected by many factors such as epidemic development, market environment and sales channels, and the subsequent market sales situation of the vaccine is uncertain. According to the vaccination situation, the epidemic prevention effect and adverse reactions may be affected by individual differences.
4. V-01 is developed by lizumab in cooperation with the Institute of Biophysics, Chinese Academy of Sciences. The intellectual property rights formed in the process of R & D and the income or income formed after listing and sales comply with relevant agreements or contracts.
The company will timely fulfill the obligation of information disclosure according to the follow-up progress. Please make prudent decisions and pay attention to investment risks.
It is hereby announced.
February 17, 2002
