Nuggets innovative medicine is jointly launched by the daily economic news and Yaodu data. It aims to interpret the progress and trend of new drug research and development, analyze product competitiveness and market prospects, gain insight into the context of pharmaceutical capital, and witness the high-quality development of the pharmaceutical industry.
According to the data of Yaodu, from December 13 to December 19, the drug evaluation center (CDE) of the State Drug Administration received a total of 8 applications for new chemical drugs, 8 therapeutic biological products and 1 preventive biological product submitted by 15 listed companies.
One week new drug application
In terms of listed companies this week, Jiangsu Hengrui Medicine Co.Ltd(600276) (600276, SH) applied for 2 production applications and 1 clinical application; Shanghai Allist Pharmaceuticals Co.Ltd(688578) (688578, SH), Sinocelltech Group Limited(688520) (688520, SH), Changchun High And New Technology Industries (Group) Inc(000661) (000661, SZ), Shanghai Junshi Biosciences Co.Ltd(688180) (688180, SH) apply for one production application respectively; Corning Jerry Pharmaceutical (09966, HK), Heyu (02256, HK), Livzon Pharmaceutical Group Inc(000513) (000513, SZ), Liaoning Chengda Biotechnology Co.Ltd(688739) (688739, SH), Cinda Biology (01801, HK), kangfang Biology (09926, HK), Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) (600196, SH), Hansen Pharmaceutical (03692, HK), and platinum medicine (02142, HK), Humanwell Healthcare (Group) Co.Ltd(600079) (600079, SH) apply for one clinical application respectively.
One week hot review
1。 Liaoning Chengda Biotechnology Co.Ltd(688739) the clinical application for fifteen price HPV vaccine was accepted, and the competition for high price vaccines intensified
On December 16, Liaoning Chengda Biotechnology Co.Ltd(688739) announced that the application for clinical trial of recombinant fifteen valent human papillomavirus vaccine (Escherichia coli) developed by the company in cooperation with Kangle guard (833575, NQ) was accepted. Liaoning Chengda Biotechnology Co.Ltd(688739) said that the fifteen valent HPV vaccine jointly developed by the company can prevent all high-risk HPV viruses and HPV6 / 11 types highly related to condyloma acuminatum, and can be used to prevent corresponding types of persistent infection and related diseases such as cervical cancer, vulvar cancer, vaginal cancer, anal cancer and condyloma acuminatum, cin1 / 2 / 3, cervical adenocarcinoma in situ, vin2 / 3, van2 / 3, ain1 / 2 / 3, etc, The preventive effect on cervical cancer reached more than 96%.
Human papillomavirus (HPV) infection is closely related to cervical cancer, which is a common malignant tumor that seriously threatens women's health. According to the different pathogenicity of HPV, it can be divided into low-risk HPV and high-risk HPV. Low-risk HPV includes HPV-6, HPV-11, hpv-34, etc. after infection, it often causes genital warts, oral and laryngeal tumors, etc; High risk HPV includes HPV-16, HPV-18, HPV-31, hpv-33, etc. infection is one of the main causes of a variety of cancers, among which cervical cancer is more common.
industry insight:
According to the report released by the international agency for research on cancer (IARC) under the World Health Organization, there were 600000 new cervical cancer cases in the world in 2020, of which nearly 110000 were in China; In 2020, the number of deaths due to cervical cancer in the world reached 340000.
Liaoning Chengda Biotechnology Co.Ltd(688739) according to the data of frost Sullivan, in 2018, the market scale of HPV vaccines with two, four and nine prices in China reached 1.58 billion yuan, 3.03 billion yuan and 1.23 billion yuan respectively. It is expected to increase to 8.23 billion yuan, 15.8 billion yuan and 6.38 billion yuan respectively in 2023. The annual compound growth rate of HPV vaccine market from 2018 to 2023 is 39.1%. At present, there is no fifteen price HPV vaccine on the market in China, and its potential market scale is expected to reach 15.1 billion yuan in 2023.
The world's first HPV vaccine was born in 2006, but it was not until 2016 that GlaxoSmithKline's bivalent HPV vaccine was approved for marketing in China. At present, four HPV vaccines have been approved for marketing in China, namely, the bivalent HPV vaccine of GlaxoSmithKline, the tetravalent HPV vaccine and jiuvalent HPV vaccine of MSD, and the bivalent HPV vaccine of Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) (603392, SH).
On November 17, 2020, the World Health Organization issued the global strategy for accelerating the elimination of cervical cancer. 194 Member States, including China, made a joint commitment to eliminate cervical cancer. Since last year, Inner Mongolia Eerduosi Resources Co.Ltd(600295) , Xiamen, Jinan and other places have successively piloted free HPV vaccination. Under the favorable policy of , the market demand for HPV vaccine is expanding rapidly. On the other hand, China's nine valent HPV vaccine is still in short supply.
Under the huge market demand, Chinese pharmaceutical enterprises are also stepping up R & D. According to the data of Yaodu, the bivalent HPV vaccine of Walvax Biotechnology Co.Ltd(300142) (300142, SZ) has been applied for production. At present, 13 HPV vaccines with different prices are in clinical trials. Among them, the nine valent HPV vaccines of Beijing Wantai Biological Pharmacy Enterprise Co.Ltd(603392) , Kangle guard, Shanghai Bowei Biotechnology Co., Ltd. and Beijing anbaisheng Biotechnology Co., Ltd. are in phase III clinical stage.
comments:
The researcher of nuggets innovative medicine believes that from the perspective of the time of entering the clinical trial, Liaoning Chengda Biotechnology Co.Ltd(688739) fifteen valent HPV vaccine is not too early. It lags behind the clinical progress of many Chinese pharmaceutical enterprises, but the victory is to achieve the full coverage of high-risk HPV virus. From the perspective of the development trend of HPV vaccine, due to the stronger protection of high price secondary vaccine, it is the market development trend for high price secondary vaccine to replace low price secondary vaccine. GlaxoSmithKline's bivalent HPV vaccine and MSD's tetravalent HPV vaccine have gradually withdrawn from the markets of European and American countries, and many pharmaceutical enterprises at home and abroad are trying to develop higher price secondary vaccine.
with the continuous promotion of the global strategy to accelerate the elimination of cervical cancer and considering that there is no domestic HPV vaccine with higher price in China, there is still a huge market space for high price HPV vaccine. Liaoning Chengda Biotechnology Co.Ltd(688739) fifteen valent HPV vaccine is the world's first fifteen valent HPV vaccine entering the clinical stage. Because the clinical application of the drug has just been accepted, there are many uncertainties in the future test results. if the drug can successfully complete the clinical trial and go on the market in the future, it is expected to gradually replace the low-cost HPV vaccine in the market and support the continuous growth of the company's performance.
2。 Shanghai Allist Pharmaceuticals Co.Ltd(688578) the indications for first-line treatment of vometinib tablets are planned to be included in the priority review procedure, which is expected to accelerate the commercialization and high-volume
On December 9, Shanghai Allist Pharmaceuticals Co.Ltd(688578) announced that the company's drug marketing license application for first-line treatment indications of vometinib mesylate tablets (hereinafter referred to as vometinib tablets) was included in the publicity list of varieties to be evaluated first by CDE. Vometinib tablet is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). It is a class 1 new drug independently developed by the company. It is a small molecule targeted drug. It is the company's current core product. It is used for the treatment of advanced small cell lung cancer (NSCLC). Its second-line treatment adaptation certificate has been approved for listing in March this year.
According to the company, the phase III clinical study of vometinib tablets for the first-line treatment of locally advanced or metastatic NSCLC with EGFR sensitive mutation has recently reached the main end point. Compared with the control group treated with gefitinib (Iressa) of the first generation EGFR-TKI, the vometinib tablet treatment group showed a statistically and clinically significant PFS benefit.
industry insight:
According to the report released by IARC, in 2020, there will be 2.2 million new cases of lung cancer and 1.8 million new deaths worldwide. The incidence rate of non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 85% of the total lung cancer. According to frost Sullivan's data quoted in the prospectus, the number of new cases of global non-small cell lung cancer increased from 1.593 million in 2014 to 1.78 million in 2018, with a compound annual growth rate of 2.8% from 2014 to 2018; It is estimated that by 2023, the number of new cases of global non-small cell lung cancer will reach 2044000, and by 2030, the number of new cases of global non-small cell lung cancer will reach 2459000.
Relevant data also show that in 2018, the market scale of targeted drugs for non-small cell lung cancer in China reached 12.73 billion yuan, with a CAGR of 27.6% from 2014 to 2018, 55.55 billion yuan in 2023 and 34.3% from 2018 to 2023. The market of targeted drugs for non-small cell lung cancer in China can be divided into biological drugs and small molecule targeted drugs. In 2018, small molecule targeted drugs accounted for more than 60% of the total market share, mainly EGFR small molecule targeted inhibitors.
vometinib tablet is the core product of Shanghai Allist Pharmaceuticals Co.Ltd(688578) and the only commercial product of the company at present. in March this year, the indications for second-line treatment of vometinib tablets were approved for listing, becoming the second domestic third-generation EGFR new drug approved for listing. In the first three quarters of this year, the company achieved a revenue of 488 million yuan and a net profit attributable to the parent company of 135 million yuan. After the commercialization of vometinib tablets, the company achieved a high sales revenue.
comments:
At present, many targeted drugs for the first-line treatment indications of advanced non-small cell lung cancer have been approved for marketing in China, and many similar drugs are in different clinical trial stages. It is not too early for vometinib tablets to be officially approved as first-line treatment indications in 2022. After vometinib tablets are approved for marketing, they will face direct competition with similar competitive products already on the market, Shanghai Allist Pharmaceuticals Co.Ltd(688578) has no first mover advantage. it is noteworthy that on December 3, Shanghai Allist Pharmaceuticals Co.Ltd(688578) announced that vometinib tablets were included in the national medical insurance catalogue for the first time.
Researchers of Nuggets innovative drug believe that with the inclusion of vometinib tablets in the medical insurance catalogue, it will further improve the accessibility of the drug to Chinese patients with non-small cell lung cancer and expand the number of beneficiary groups of Chinese patients with non-small cell lung cancer ; Despite the fierce market competition, from the sales of its second-line indications in the first three quarters of this year, after its first-line treatment indications are officially approved, it is expected to accelerate the commercialization and further expand the sales scale of vometinib tablets.
(Daily Economic News)
