BeiGene's 22 Class 1 New Drugs Are Eye-catching, Over 10 New Drugs "Going Overseas to Take the Test"

On February 25, BeiGene released its 2021 performance report.
The company achieved revenue of about US$1.
2 billion, a year-on-year increase of about 280.
8%, of which product revenue reached US$634 million (about 4 billion yuan), a year-on-year increase of about 105%; research and development; The cost is about 1.
5 billion US dollars, a year-on-year increase of 13%, which is overwhelming a number of listed pharmaceutical companies
.
At present, BeiGene has 3 self-developed Category 1 new drugs approved.
In addition, 22 Category 1 new drugs are in the stage of clinical application and above in China, of which 3 have entered Phase III clinical trials and are expected to be launched
.
In terms of internationalization, BeiGene has set a record for the highest amount of authorized cooperation for a single product in China, and more than 10 self-developed innovative drugs have been clinically launched overseas, of which zanubrutinib has achieved a "zero breakthrough"
.
"R&D King" in pharmaceutical stocks, innovative drugs sell for 4 billion BeiGene is a global biopharmaceutical company based on science, focusing on the development of innovative and affordable drugs
.
In terms of research and development, BeiGene has always been willing to "spend" a lot of money, and its research and development investment has overwhelmed a number of listed pharmaceutical companies.
It is a well-deserved "R&D king"
.
BeiGene’s R&D investment (unit: USD 100 million) Source: Listed company announcement The proportion of income exceeds 100%
.
At present, the company has built a team of more than 8,000 people on five continents and has more than 40 clinical drug candidates
.
In recent years, BeiGene's research and development achievements have been realized one after another
.
Since 2020, a number of new drugs of the company have been approved for marketing in China, including 3 self-developed Category 1 new drugs, as well as imported new drugs stuximab, carfilzomib and datuximab beta (formerly (named dituximab), belintuximab, etc..
Sources of new drugs approved by BeiGene in China from 2020 to now: Minenet MED2.
0 Chinese Drug Evaluation Database Tislelizumab is the 4th domestic PD-1 approved in China.
At present, the product has 6 5 indications have been approved, 5 of which have been included in the national medical insurance catalog through negotiation, and the medical insurance payment standard is 1,450 yuan/piece (100mg/piece)
.
According to the company's annual report, the sales revenue of tislelizumab in China in 2021 will reach 255.
1 million US dollars (about 1.
6 billion yuan)
.
Zanubrutinib is the first domestic BTK inhibitor approved in China.
Currently, 3 indications have been approved, and all of them have been included in the national medical insurance catalog through negotiation.
The medical insurance payment standard is 85 yuan/capsule (80mg/capsule, 64 tablets/bottle), the global sales revenue in 2021 will reach 218 million US dollars (about 1.
4 billion yuan)
.
In addition, Pamiparib, approved in May 2021, was also included in the national medical insurance catalog through negotiation, and the medical insurance payment standard is 53.
6 yuan/capsule (20mg/capsule; 60 capsules/bottle)
.
The innovative achievements are gradually commercialized, allowing BeiGene's product revenue to continue to grow and the "stamina" to continue to be released
.
In 2021, the company's total operating income will be about 1.
2 billion US dollars, a year-on-year increase of 280.
8%, of which product revenue will be 634 million US dollars (about 4 billion yuan)
.
22 class 1 new drugs under development are eye-catching, many of which are sprinting for the first domestic BeiGene Some innovative drugs under development in China It covers subdivided cancers such as non-small cell lung cancer, gastroesophageal adenocarcinoma, acute myeloid leukemia, prostate cancer, and myeloma
.
In terms of drug types, small molecule chemical drugs and macromolecular biological drugs each account for "half of the country"
.
From the perspective of research and development progress, Ociperlimab injection (BGB-A1217), Sitravatinib malate capsules, ZW25 for injection, and 3 new class 1 drugs have entered Phase III clinical trials and are expected to be launched on the market. .
BeiGene’s self-developed Ociperlimab injection (BGB-A1217) is a TIGIT inhibitor.
No drug with the same target has been approved in China.
The new drug under development is Roche’s Tiragolumab injection, which is also in Phase III clinical trials; Sitravatinib malate The capsule is an RTK inhibitor, and the global marketed drugs with the same target include EXELIXIS' cabozantinib, etc.
; ZW25 for injection is a bispecific antibody targeting HER2
.
Among other self-developed new drugs, BGB-15025 capsule is an HPK1 inhibitor and a candidate drug with "first-in-class" potential.
At present, there is no drug with the same target approved in the world, and most of the new drugs under research are in preclinical stage.
Jeshenzhou is at the forefront of research and development; BGB-16673 film-coated tablet is BeiGene’s first innovative drug developed based on its protein-degrading CDAC (innovative PROTAC) platform and entered the clinical stage.
B-cell malignancies,
etc.
In the introduction of new drugs, BeiGene reached a cooperation with Amgen in November 2019 to jointly develop 20 of Amgen's anti-tumor drugs under research, many of which have the best-in-class or first-in-class potential, including AMG160, AMG 701, AMG 650 , AMG 510, AMG 199, etc.
have been approved for clinical use in China
.
More than 10 self-developed new drugs are "going overseas to take the test", and the license-in & out dual-cycle layout In recent years, with the improvement of domestic pharmaceutical companies' R&D capabilities and the accumulation of domestic innovative drugs, going overseas has become an inevitable choice for many pharmaceutical companies
.
At present, BeiGene has more than 10 self-developed new drugs in clinical trials overseas.
Among them, zanubrutinib was approved by the FDA in November 2019, achieving a "zero breakthrough" in domestic anti-tumor innovative drugs, and its commercialization layout has covered More than 40 countries and regions around the world
.
In addition, the marketing application of tislelizumab for metastatic esophageal cancer (ESCC) has been accepted by the FDA, and the first-line HCC, second-line NSCLC and other indications are in phase III clinical; Other indications are in Phase III clinical trials worldwide
.
In addition to the above three core products, BeiGene's BGB-A1217 (ociperlimab, TIGIT monoclonal antibody), BGB-283 (lifirafenib, EGFR/B-RAF), BGB-11417 (BCL-2 inhibitor), BGB-A425 ( TIM3 monoclonal antibody), BGB-3245 (B-RAF inhibitor), BGB-10188 (PI3Kδ inhibitor) and other self-developed new drugs are in different clinical stages around the world
.
The dual cycle of license-in & out has become a new trend for local innovative pharmaceutical companies to integrate with internationalization
.
In recent years, BeiGene has cooperated with well-known multinational pharmaceutical companies such as Bristol-Myers Squibb, Amgen, EUSA, and Novartis to carry out drug licensing cooperation
.
It is worth noting that in January 2021, Novartis introduced BeiGene's PD-1 antibody tislelizumab for US$2.
2 billion, which was the highest domestic down payment amount and single-variety authorized transaction amount at the time.
It has become the largest cooperation project in the authorization of a single drug in China
.
Less than a year later (December 2021), Novartis and BeiGene reached a cooperation agreement again.
Novartis obtained the overseas rights and interests of BeiGene TIGIT antibody BGB-A1217 with a total amount of over 2.
9 billion US dollars, which once again refreshed the domestic single product authorization.
The highest cooperation amount on record
.
At present, there are very few entrants in the TIGIT field, and BeiGene's clinical progress is ahead.
In addition, Roche, Merck, Gilead and other companies have also made outstanding progress in research and development of products with the same target
.
In the era of PD-(L)1 blooming everywhere, the emergence of TIGIT can enable more tumor patients to respond to PD-1 and jointly enhance anti-tumor immunity, which has become the key layout direction of K drugs and O drugs
.
The combination of PD-1 and TIGIT target may become the best choice for companies to overtake in corners, which may be the reason why Novartis is willing to spend a lot of money to join hands with BeiGene
.
Going overseas with the help of the license-out model can save money in the early stage of enterprise development, quickly realize commercialization benefits with the help of the sales network of international pharmaceutical companies, and provide management experience for the comprehensive internationalization of future products of the enterprise. .
However, in the long run, it is difficult for a single license-out model to face sales competition in overseas markets
.
For a Biopharma such as BeiGene, "shipbuilding to the sea" is not limited to License-out, but needs to further improve its overseas sales network, so as to comprehensively enhance the competitiveness of its international commercialization model
.