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Recently, Haosen Pharmaceutical's product line has made new progress: the introduction of heavy dual antibodies has been lavishly introduced, and the first clinical application of Class 1 new drug HS-10390 tablets.
.
.
According to data from Minai.
com, in the past three years, Haosen Pharmaceutical has reached more than 10 cooperations and introduced a variety of differentiated new drugs, and 33 new drugs (29 Class 1 new drugs) are currently in the clinical application stage and above, and the 6th Class 1 new drug can be expected to be launched; In terms of generic drugs, since 2017, the company has approved 13 first generic (including the first generic of dosage form), in addition to 10 new classification product varieties under review, of which 6 have not been approved
for the first time.
Won 13 first imitations, 6 new drugs, and 5 varieties to pass the new medical insurance
The national health insurance negotiations in 2022 are in full swing
.
Judging from the preliminary review list announced some time ago, Haosen Pharmaceutical has 5 off-list varieties listed, all of which are new generic drugs
approved by the national drug administration from January 1, 2017 to June 30, 2022.
According to data from Minai.
com, since 2017, more than 30 varieties of Haosen Pharmaceutical have been approved for marketing, of which 6 are new drugs (4 Class 1 new drugs, 1 imported new drug and 1 improved new drug).
At present, the company has approved 7 new drugs (5 Class 1 new drugs) for marketing, thanks to the successive approval and commercialization of innovative drugs, Haosen Pharmaceutical's innovative drug revenue increased from 750 million yuan in 2020H1 to 2.
32 billion yuan in 2022H1, and the proportion of innovative drug revenue in total revenue increased from 18.
9% in 2020H1 to 52.
3%
in 2022H1.
In addition, 13 are first generic (including dosage form first genetic), covering 8 therapeutic categories, of which 5 are digestive system and metabolite drugs, and 3 are anti-tumor and immunomodulatory agents
.
At present, the company also has 10 new classification products under review, of which 6 have not yet been approved
.
Since 2017, Haosen Pharmaceutical has been approved for marketing of new drugs and the first generics
Source: Minai.
com China Declaration Progress (MED) database
Among the 6 exclusive innovative drugs that Haosen Pharmaceutical has marketed, 5 have been included in the national medical insurance catalog through negotiation, among which the new indication of ametinib mesylate tablets is expected to participate in the 2022 medical insurance negotiations; Inelizumab injection (the first anti-CD19 monoclonal antibody in China), which was approved for marketing in 2022, has passed the formal review and is expected to be included in the 2022 medical insurance
through negotiation 。
In the past three years, more than 10 cooperation projects have been reached, and a variety of differentiated new drugs have been introduced
On November 14, Hausen Pharmaceutical announced that the company signed a license agreement with Pumeis to obtain the exclusive rights to develop and commercialize PM1080 in Greater China (including Chinese mainland, Hong Kong, Macau and Taiwan), and pay Pumeis a down payment of 50 million yuan and potential payments of up to 1.
418 billion yuan in development, registration and sales-based commercialization milestones, as well as tiered royalties
based on net sales 。
PM1080 is an EGFR/c-Met bispecific antibody drug with great therapeutic potential
to block the signaling of EGFR and c-Met at the same time, inhibit tumor growth and survival.
At present, no EGFR/c-Met bispecific antibody has been approved for marketing in China, and PM1080 is in the preclinical research stage
.
In recent years, Haosen Pharmaceutical has continuously increased external cooperation to expand its product pipeline, and has reached more than 10 BD transactions since 2020, including Pumis, NiKang, TiumBio, GHDDI, Terns, Scynexis, Silence, Zhidao Biotechnology, Wangshi Wisdom, etc.
, of which the total amount of transactions with Silence has exceeded US$1.
3 billion
。
Since 2020, Haosen Pharmaceutical has partially introduced projects
Source: Company announcement, Minainet collation
From the perspective of the projects introduced by Haosen Pharmaceutical in recent years, they are mainly divided into three types: first, mature innovative products in the late clinical stage, such as the new antifungal drug ibrexafungerp, which was approved for marketing in the United States in 2021 and is currently in phase III clinical trials in China; The second is to introduce early-stage products and enrich pipeline reserves, such as the introduction of three siRNA drugs from Silence; The third is to introduce global advanced technology platforms, such as AI-enabled drug molecule design platform and GalNAc-asiRNA platform
.
From the perspective of the progress of the research and development of new drugs introduced, the indications of ibrexafungerp (dextran synthetase inhibitor) vulvovaginal candidiasis have been carried out in phase III clinical trials in China; RN-000632 (Bcr-Abl inhibitor) chronic myeloid leukemia indication in China for phase I clinical trials; The world's highest R&D progress of KER-050, NKT2152 and TU2670 have all entered phase II clinical trials, and no clinical
trials have been declared in China.
33 new drugs are on the way, and the sixth class 1 new drug is about to be launched
In addition to actively exploring possible BD cooperation, Haosen Pharmaceutical is also constantly increasing its independent research and development
.
According to the half-year performance report, the company's R&D expenditure in 2022H1 was 739 million yuan, a year-on-year increase of 7.
6%, accounting for 16.
7% of revenue (15.
6% in the same period of 2021).
。
R&D expenditure of Haosen Pharmaceutical in the same period from 2020 to 2022 (: million yuan)
Source: Company announcement
According to data from Minai.
com, at present, Haosen Pharmaceutical has 33 innovative drugs in the clinical application stage and above (excluding new indications for new drugs that have been marketed), covering anti-tumor, nervous system, anti-infection, digestive tract, cardiovascular and other therapeutic fields, of which 29 are Class 1 new drugs
.
Haosen Pharmaceutical is developing new drugs in China
Source: Minai.
com China Clinical Trial Database, CDE official website
Among the 29 Class 1 new drugs, 27 are chemical drugs, involving popular targets such as CDK4/6, EGFR, PIK3, and c-Met
.
The sixth class 1 new drug, pemosatide injection, is expected to be approved for marketing within this year, and the EPO drugs that have been marketed in China are mainly short-acting, and no domestic long-acting EPO drugs have been approved
.
According to data from Minai.
com, in 2021, the sales scale of end-human erythropoietin/recombinant human erythropoietin in China's urban public hospitals, county-level public hospitals, urban community centers and township hospitals (referred to as China's public medical institutions) exceeded 3.
5 billion yuan
.
Haosen Pharmaceutical's layout of biological drugs class 1 new drugs is not much, but concentrated in the ADC high-potential track, the ADC drug HS-20093 targeting B7-H3 (CD276) and the ADC drug HS-20089 targeting B7-H4 are all in phase I clinical trials
for solid tumor indications.
Non-Class 1 new drugs focus on high-end formulations and biosimilars
.
Tadalafil oral film is the second oral film reported by the company, and the first oral film - olanzapine oral film has been approved in 2020; HS-20090 injection is a biosimilar of denosumab, which is currently undergoing phase III clinical trials, and Amgen's global sales of denosumab exceeded $5 billion
in 2021.
Source: Minainet database, company announcements, etc
Note: Minai.
com's "Drug Terminal Competition Pattern of Public Medical Institutions in China", the statistical scope is: China's urban public hospitals, county-level public hospitals, urban community centers and township health centers, excluding private hospitals, private clinics and village clinics; The above sales are calculated
based on the average retail price of the product at the terminal.
Data statistics as of November 18, if there is any omission, welcome to correct!
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