11 new drugs under research from innovative pharmaceutical companies are coming, and there are more than 1 billion varieties of drugs.

A few days ago, Chi-Med Pharmaceutical released its 2021 performance report.
The company's annual revenue reached US$356 million, a year-on-year increase of 56%
.
The total sales of the three Class 1 new drugs that have been approved for marketing reached US$98.
5 million, a year-on-year increase of 192%
.
In terms of pipeline layout, Chi-Med focuses on the "First in class" innovative development model, and builds a number of class 1 new drugs in the anti-tumor field.
.
.
In terms of internationalization, the class 1 new drug surufatinib will soon sprint US market
.
In addition, Chi-Med announced on March 7 that the company received a milestone payment of $15 million from AstraZeneca
.
The milestone payment is triggered by the initiation of a global Phase III study of Chi-Med's class 1 new drug, sivotinib
.
To date, AstraZeneca has paid Chi-Med an upfront payment under the license and collaboration agreement, $140 million in total development and $85 million in first commercial sales milestone payments
.
Annual revenue exceeds 2 billion yuan, 3 new class 1 drugs have been approved %
.
At present, Chi-Med Pharmaceutical has launched 3 new Class 1 drugs in China, including savatinib (Vorexa), fruquintinib (Aiyoute) and surufatinib (Suteda), with total sales in 2021.
The amount reached 98.
5 million US dollars (about 620 million yuan), a year-on-year increase of 192%
.
Source of domestically marketed drugs of Chi-Med Pharmaceuticals: Minenet Global New Drug Development Database Sivotinib is an oral MET tyrosine kinase inhibitor approved for marketing in China in June 2021 for the treatment of patients with MET exon 14 mutations It has become the first domestically produced MET inhibitor, with sales of US$15.
9 million (about 100 million yuan) in 2021
.
Fruquintinib was approved in September 2018 and became the first self-developed class 1 anti-cancer drug to be marketed in China at that time, with sales of 71 million US dollars (about 450 million yuan) in 2021
.
At present, two new drugs, fruquintinib and surufatinib, have been included in the national medical insurance catalog through negotiation.
The medical insurance payment standard for fruquintinib is 1984.
5 (1mg*21 capsules), and surufatinib is 2035.
32 yuan per box (50mg).
*42 capsules)
.
11 new drugs under development are eye-catching, seizing the market of over 1 billion varieties.
In terms of R&D innovation, Chi-Med focuses on the "First in class" innovative development model, and its R&D investment has increased year by year in recent years
.
In 2021, Chi-Med's R&D expenditure will reach US$299 million (about 1.
89 billion yuan), a year-on-year increase of 70.
9%, and R&D expenditure will be close to total operating income
.
Chi-Med’s R&D expenditure (unit: US$100 million) Source: Listed company announcement According to the global new drug R&D data of Minet, Chi-Med has more than 20 new drug R&D projects, most of which are original research class 1 small molecule drugs, and the product pipeline covers tumors , immune regulation, digestion and metabolism, skin and hematopoietic system and other therapeutic areas, of which there are about 11 candidate drug projects under development with rapid progress, mainly anti-tumor drugs
.
From the perspective of clinical progress, the highly selective Syk inhibitor HMPL-523 has entered the clinical phase III for the treatment of immune thrombocytopenic purpura.
The only drug with the same target that has been approved globally is fotatinib from Rigel Pharmaceuticals Sodium (TAVALISSE), the global sales of this product in 2021 will reach 63 million US dollars (about 398 million yuan); in addition, HMPL-689, HMPL-453, xilitinib, epitinib, etc.
are in the phase II clinical stage
.
Tazemetostat is the only new drug introduced by Chi-Med.
This drug is an EZH2 inhibitor authorized by Epizyme.
There is no drug with the same target approved for marketing in the world.

.
At present, Tazemetostat has been listed in the United States, Japan and other countries and regions, and a bridging study in the treatment of follicular lymphoma has been initiated in China.
By analyzing the clinical data of different target drugs in relapsed and refractory follicular lymphoma (FL) alone It was found (ORR as high as 69%) that the single-agent activity of the drug is much higher than that of BTK inhibitors (including BeiGene zanubrutinib), PI3K inhibitors and BCL2 inhibitors, and its safety is also more significant.
After the listing, it will carve up the market position of over 1 billion varieties such as zanubrutinib
.
Source of some candidate drug pipelines of Chi-Med Pharmaceuticals: Minet.
com Global New Drug R&D Database Class 1 new drugs are about to go on the market in the United States, leading the exploration of the modernization of traditional Chinese medicine In recent years, innovative drugs going overseas has become a hot topic in the pharmaceutical industry
.
As a leading innovative drug company in China, Chi-Med Pharmaceuticals has already started to distribute innovative drugs to overseas markets in 2006.
At that time, the company's self-developed Chinese medicine andrographis paniculata preparation HMPL-004 successfully obtained FDA clinical research approval.
Strong attention from domestic and foreign medical circles
.
However, due to flaws in formulation selection and study design, the Phase III clinical study of HMPL-004 was terminated at the interim analysis
.
Even if the internationalization of HMPL-004 has not been successfully completed, the project covers the exploration experience of new drugs going overseas and the modernization of traditional Chinese medicine, which are of great interest today
.
It is not easy for Chinese patent medicine to enter the international market.
TCM clinicians increase or decrease the flavor of medicine according to the specific condition of the patient or appropriately increase or decrease the dosage of some medicinal flavors, and emphasize individualized medicine based on people
.
If large-scale production is to be transformed into group medicine, the efficacy of Chinese patent medicines needs to be evaluated according to the method of modern scientific demonstration, and the whole process from Chinese medicinal materials to finished products needs to be subject to strict quality control.
This is the challenge of domestic Chinese medicines and Chinese patent medicines going overseas It is also one of the difficulties in the modernization of traditional Chinese medicine
.
According to incomplete statistics, at least 10 proprietary Chinese medicines have submitted IND applications to the FDA, many of which are "star varieties" such as Compound Danshen Dripping Pills and Lianhua Qingwen Capsules
.
In addition to Chi-Med HMPL-004, Tasly's Compound Danshen Dripping Pill is also facing a "failure" in the FDA's Phase III clinical trials.
blow
.
So far, no domestic Chinese patent medicine has been marketed in the United States.
Whether the domestic Chinese patent medicine can create a history and be recognized by the FDA still needs time to verify
.
Compared with the leading exploration of the modernization of traditional Chinese medicine, Chi-Med's small molecule innovative drugs are going overseas relatively smoothly
.
At the end of April 2022, the FDA will conduct a targeted review of surufatinib in the United States, and Su Weiguo, CEO of Chi-Med, once expressed confidence in this
.
At the beginning of this year, the domestic PD-1 was blocked in the FDA listing, which sounded the alarm to the domestic pharmaceutical industry.
However, surufatinib has met the two criteria of multi-regional clinical trials and clinical needs
.
At present, surufatinib has carried out a number of proof-of-concept studies in Europe, the United States, China and other regions.
On this basis, it has obtained good clinical data in the United States, and has obtained FDA fast track and orphan drug certification.
From this point of view FDA approval of surufatinib in the U.
S.
is just around the corner
.
Source: company annual report, new version database of Minet Note: The exchange rate involved in the article is calculated on March 11.
If there are any mistakes or omissions, please correct me
.