Class 1 new drugs sold 10 billion yuan, innovative drug companies "attack" the 100 billion tumor drug market

As the first batch of innovative drug research and development companies in China, Betta Pharmaceuticals has spent ten years to create a tens of billions of original innovative drugs, breaking the single-product sales pattern
.
In 2021H1, the company achieved a net profit of 215 million yuan, a year-on-year increase of 49.
57%.
The total sales of icotinib and enzatinib were 1.
135 billion yuan
.
At present, Betta Pharmaceuticals has 19 main research projects, focusing on the field of anti-tumor, covering popular targets such as CDK4/6 inhibitors, PD-1 monoclonal antibodies, FGFR inhibitors, etc.
Bevacizumab and third generations have been reported for production The first-line treatment of EGFR-TKI Befortinib and Ensatinib is expected to be on the market in the past year or two
.

Net profit soared by 50% ! A total of 10 billion yuan of new drugs sold in category 1
On August 10, Betta Pharmaceuticals released its 2021 semi-annual report.
The company achieved revenue of 1.
155 billion yuan, a year-on-year increase of 21.
35%; net profit attributable to shareholders of listed companies was 215 million yuan.
A year-on-year increase of 49.
57%; net profit attributable to shareholders of listed companies after deducting non-recurring gains and losses was 198 million yuan, a year-on-year increase of 39.
85%
.
Net profit of Betta Pharmaceuticals (unit: 100 million yuan) Betta Pharmaceuticals stated that the semi-annual net profit of 2021 will continue to grow despite the high base of the same period last year, not only because of the continuous increase of Kemena (Icotinib), but also Also benefited from the continuous improvement of the company's operating capabilities
.
Icotinib is not only the first class 1 new drug of Betta Pharmaceuticals, but also the first class 1 small molecule oral targeted new drug with independent intellectual property rights in China
.
As the core product of Betta Pharmaceuticals, Kaimana's sales have grown steadily, with sales revenue of 1.
08 billion yuan in 2021H1, a year-on-year increase of 16.
85%
.
It is worth mentioning that 2021 is the tenth year of Kaimana’s listing.
Kaimana has exceeded 1 billion yuan in annual sales for 5 consecutive years, and cumulative sales revenue has exceeded 10 billion yuan.

.
Bemena (Ensatinib) was approved for listing in China in November 2020.
It is the company's second lung cancer targeted Class 1 new drug and the first domestically-made ALK inhibitor
.
In 2021H1, Bemena's sales revenue reached RMB 54.
97 million, breaking the company's single product sales pattern
.

　EGFR and ALK inhibitors are driven by two wheels, preparing for national medical insurance negotiations.

At present, Betta Pharmaceuticals has only two Class 1 new drugs that have been commercialized, including the first-generation EGFR-TKI icotinib and the ALK inhibitor Ensatinib
.
The company's third-generation new drug Befortinib is the third-generation EGFR-TKI
.
It is not difficult to find that the three consecutive Class 1 new drugs of Betta Pharmaceuticals are all targeted drugs for the treatment of lung cancer, as well as tinib drugs
.
In recent years, domestic pharmaceutical companies have been enthusiastic about the research and development of tinib drugs, and their market has also shown huge growth potential
.
According to data from Menet.
com, in 2020, the terminal market of protein kinase inhibitors in China's urban public hospitals , county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) will exceed 26 billion yuan, with sales in 2018-2020 The growth rates were 40.
31%, 57.
58%, and 29.
79%
.
Sales of terminal protein kinase inhibitors in public medical institutions in China (unit: 10,000 yuan) Source: Mynet.
com.
The competitive landscape of terminal protein kinase inhibitors in public medical institutions in China has been accompanied by the increasing popularity of tinib drugs.
During the ten years of listing of icotinib, Bei Da Pharmaceutical has met many challenges, including medical insurance negotiations, a 76.
8% price reduction for gefitinib, and market concerns about its dominance
.
In the face of various challenges, Betta Pharmaceuticals implemented a differentiated competitive strategy for Kaimena, guided the market with academics, and maintained a leading position among similar products by virtue of its high efficiency and low toxicity
.
After careful study, Kemena’s "counter-attack" is inseparable from the academic research and commercialization capabilities behind it.

.
During the 2021 Misconference, Wan Jiang, senior vice president and chief operating officer of Betta Pharmaceuticals, told everyone that Icotinib has been doing head-to-head research with gefitinib, chemotherapy, and whole-brain radiotherapy.
Ensure that the product always has the latest data for ten years, and let the experts publish it at the top academic conference
.
He emphasized that it is necessary to become a benchmark Chinese oncology innovative drug to get a share of the fierce competition
.
At the same time, the company has built a strong commercialization team and an in-depth distribution network
.
This enables Chemena to continue to grow rapidly under the 4+7 situation in 2019, with a compound growth rate of 36%, achieving an overall surpassing of Iressa in hospitals and out-of-hospitals
.
In the ever-changing market environment, the challenge that Betta Pharmaceuticals faces has never ended
.
On July 30, the National Medical Insurance Administration announced that the 2021 National Medical Insurance Drug List was adjusted and passed the preliminary formal review of the drug list.
Icotinib Hydrochloride Tablets and Ensatinib Hydrochloride Capsules are all listed
.
In 2015, Icotinib participated in the first national drug negotiation and voluntarily reduced its price by 54%, becoming the first domestically-made innovative drug to enter the national medical insurance catalog
.
In June 2021, the indications for postoperative adjuvant treatment of icotinib were approved for marketing, which caught up with this year's national medical insurance negotiations
.
Ensatinib is the only ALK inhibitor not included in the medical insurance.
The imported original drugs crizotinib, ceritinib, and aletinib have been included in the national medical insurance negotiation catalog for many times
.
Therefore, the market access team of Betta Pharmaceuticals carefully studied local access policies, discussed and formulated access plans, and prepared for the national medical insurance negotiations
.

　　16 new class 1 drugs are dazzling! "Strike" the 100 billion anti-tumor drug market
As China's first batch of innovative drug R&D companies , Betta Pharmaceuticals has always adhered to the core strategy of innovation
.
The company continues to increase R&D investment, and has established a variety of R&D pipelines through independent R&D and strategic cooperation
.
In 2021H1, Betta Pharmaceuticals' R&D investment reached 398 million yuan, accounting for 34.
49% of operating income
.
Betta Pharmaceuticals’ R&D investment (unit: 100 million yuan) As of July 31, 2021, Betta’s main research projects have 19 varieties, including 16 Class 1 new drugs.
Those who have submitted marketing applications include MIL60 (Bei Da (Valizumab), Class 1 new drug BPI-D0316 (Befortinib), Ensatinib are indications for first-line treatment
.
Among them, bevacizumab biosimilars are expected to be approved for marketing at the end of the year as soon as possible, sprinting to be the fifth domestic product; bevacizumab and enzatinib (first-line treatment) are expected to be approved for marketing as soon as 2022
.
Betta Pharmaceuticals has 19 main research projects under development, 14 small-molecule innovative drugs and 5 antibody drugs
.
From the perspective of therapeutic areas, 18 are anti-tumor products and 1 is diabetes products
.
According to data from Mi Nei.
com, in 2020, the sales of terminal anti-tumor drugs in public medical institutions in China will exceed 100 billion yuan, a year-on-year increase of 9.
63%
.
Sales of terminal anti-tumor drugs in public medical institutions in China (unit: 10,000 yuan) Source: Meinnet.
com The competitive landscape of terminal in public medical institutions in China.
Beida Pharmaceuticals focuses on the field of anti-tumor and has deployed a number of popular targets, including CDK4/6 inhibition agent, PD-1 mAb, CTLA-4 monoclonal antibody, FGFR inhibitors
.
Lung cancer is a key area of ​​Betta Pharmaceuticals.
The company's product pipeline focuses on patient needs and is clinically value-oriented, covering EGFR, KRAS, ALK and other mutations in non-small cell lung cancer
.
The company's deployment in the field of NSCLC treatment 5 antibody drugs including batilizumab (PD-1 antibody), zefliximab (CTLA-4 antibody), MCLA-129 (EGFR/c-Met double antibody), MIL60 and Pertumumab are products introduced by Betta Pharmaceuticals through strategic cooperation
.
Among them, MCLA-129 has started phase I clinical trials, and clinical trials of bartilimumab and zefliximab are in progress
.
Among the 14 innovative small molecule drugs, the third-generation EGFR-TKI befortinib has been reported for production; the VEGFR/PDGFR inhibitor CM082 (Voronib) is already in phase II/III clinical trials, and it is planned to apply for NDA in 2021 ; The other Class 1 new drugs have started phase I clinical trials
.

　　Data source: Mi Nei.
com database, company announcement