incredible! Class 1 new drugs sold 10 billion, innovative drug companies "strike" the 100 billion tumor drug market, and 16 Class 1 new drugs are on the way

As the first batch of innovative drug R&D companies in China, Betta Pharmaceuticals 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.

Net profit soared by 50%! A total of 10 billion yuan of new drugs sold

Net profit soared by 50%! A total of 10 billion yuan of new drugs sold

On August 10, Betta Pharmaceuticals released the 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%; attributable to listed companies The shareholders' net profit 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 said that the 2021 semi-annual net profit will continue to grow under the high base of the same period last year, not only because of the continuous increase of Kemena (Icotinib), but also 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.

It is worth mentioning that 2021 is the tenth year of Kaimana's listing.
Kaimana has annual sales revenue of more than 1 billion yuan for five 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.

Two-wheel drive of EGFR and ALK inhibitors, preparing for national medical insurance negotiations

Two-wheel drive of EGFR and ALK inhibitors, 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 Meinenet, in 2020, the size 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) terminal market will exceed 26 billion yuan, with sales in 2018-2020 The growth rates were 40.

Sales of terminal protein kinase inhibitors in public medical institutions in China (unit: ten thousand yuan)

Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

With the increasing popularity of tinib drugs, Betta Pharmaceuticals has faced many challenges during the ten years when icotinib was launched on the market, including medical insurance negotiations, a 76.
8% price reduction for gefitinib, and a unique product in the market.
and other large concerns
.

Facing 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

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 Catalogue was adjusted and passed the preliminary formal review of the drug list.

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 that is 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

16 new class 1 drugs are dazzling! "Strike" the 100 billion anti-tumor drug market

As the first batch of innovative drug research and development enterprises in China, 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 Pharmaceuticals has 19 main research projects, including 16 Class 1 new drugs.
The marketing applications that have been submitted include MIL60 (bevacizumab) and Class 1 new drug BPI-D0316 ( Befortinib) and Ensatinib are first-line indications for 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 ensatinib (first-line treatment) are expected to be approved for marketing as soon as 2022
.

Betta Pharmaceuticals' main research projects

Among the 19 main research products, there are 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: ten thousand yuan)

Source: Mi Nei.
com, China's public medical institutions terminal competition pattern

Phar focused on the anti-tumor field, layout of the plurality of hot targets, comprising CDK4 / 6 inhibitor, PD-1 mAb, CTLA-4 monoclonal antibody, FGFRs 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 layout in the field of NSCLC treatment

5 antibody drugs including bartilimumab (PD-1 antibody), zefliximab (CTLA-4 antibody), MCLA-129 (EGFR/c-Met double antibody), MIL60, 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