Securities code: Betta Pharmaceuticals Co.Ltd(300558) securities abbreviation: Betta Pharmaceuticals Co.Ltd(300558) Announcement No.: 2022028 Betta Pharmaceuticals Co.Ltd(300558) 2021 annual report summary
1、 Important tips
The summary of this annual report comes from the full text of the annual report. In order to fully understand the company's operating results, financial status and future development plan, investors should carefully read the full text of the annual report in the media designated by the CSRC.
All directors personally attended the meeting of the board of directors to consider this annual report.
The audit opinion of Lixin Certified Public Accountants (special general partnership) on the company's financial report this year is: standard unqualified opinion.
Changes of accounting firm during the reporting period: the company's accounting firm has not changed this year.
The company's profit distribution plan for ordinary shares reviewed and approved by the board of directors is: taking 415388667 shares as the base, distribute cash dividends of 2.50 yuan (including tax) to all shareholders for every 10 shares, give bonus shares of 0 shares (including tax), and transfer capital reserve to all shareholders for every 10 shares.
2、 Basic information of the company 1. Company profile
Stock abbreviation Betta Pharmaceuticals Co.Ltd(300558) stock code Betta Pharmaceuticals Co.Ltd(300558)
Shenzhen Stock Exchange
Contact person and contact information secretary of the board of directors securities affairs representative
Name: Wu Lingxi, Shen Jianhao
Office address: No. 355, Xingzhong Road, Yuhang Economic and Technological Development Zone, Hangzhou
Fax: 057189265665
Tel: 057189265665
E-mail [email protected]. [email protected].
2. Introduction to main business or products during the reporting period (1) industry of the company during the reporting period
The company's main products Kemena and bemena belong to chemical drugs. According to the relevant provisions of the industry classification guidelines for listed companies issued by the CSRC, the company belongs to the pharmaceutical manufacturing industry (classification code C27). 1) Industry development stage and cyclical characteristics
According to the data released by the National Bureau of statistics, in 2021, the operating revenue of Enterprises above Designated Size in the pharmaceutical manufacturing industry, the industry of the company, increased by 20.1% year-on-year, and the total profit increased by 77.9% year-on-year. The growth rate of operating income has been higher than that of GDP and national industrial enterprises above Designated Size for many consecutive years (see chart 1). The pharmaceutical industry, as the core of the people's demand for high-speed development in recent years, has a typical trend of maintaining the rigidity of the manufacturing industry.
Figure 1: growth curve of GDP, revenue of national industrial enterprises above Designated Size and revenue of pharmaceutical manufacturing industry from 2013 to 2021
Source: National Bureau of Statistics
In 2021, the "three medical linkage" policy was continuously improved, the R & D and innovation strength of pharmaceutical enterprises was steadily enhanced, and the pharmaceutical manufacturing and product market showed the following characteristics: a. the competition was fierce, and the market still had potential
The global tumor drug market is expanding year by year and is expected to grow further in the future. Similarly, with the expansion of China's medical insurance reimbursement scope, the improvement of patients' ability to pay and the emergence of innovative and advanced therapies, China's tumor drug market has shown a steady growth trend in recent years. According to statistics, the incidence rate and mortality rate of lung cancer is the first place in all types of cancer in China. In view of the many unmet medical needs of lung cancer treatment, lung cancer still faces challenges for modern medical treatment. China's lung cancer drug market still has great potential for growth.
At present, the target homogeneity of Chinese innovative pharmaceutical enterprises is obvious, and the competition of popular targets is fierce. The existing competitors in the industry continue to strengthen technology research and development and enrich tumor product lines, which puts forward higher requirements for the development of pharmaceutical enterprises. In the future, innovative pharmaceutical enterprises with the integration advantages of "development, clinical and commercialization" will stand out. B. Three medical linkage and continuous deepening of reform
In terms of medical insurance, the release of policies such as the opinions on promoting the normalization and institutionalization of centralized drug procurement has gradually promoted the institutionalization and normalization of drug procurement, making room for more cost-effective new drugs to enter medical insurance; Medical insurance adjusted the access mechanism, drug access negotiations gradually normalized, the success rate of negotiations continued to improve, and drugs were exchanged at price with the help of medical insurance. In medicine, the state has continuously improved the principle system of new drug review, improved the efficiency of review and approval, accelerated the listing of new drugs, and continued to deepen the reform of drug review; Encourage R & D innovation and strengthen the R & D guidance of innovative drugs. In terms of medical treatment, deepen the reform of public hospitals and promote the experience of graded diagnosis and treatment. The "three medical linkage" reform led by the National Medical Security Bureau (Medicare Bureau) continued to deepen and accelerate the healthy development of the pharmaceutical industry. C. Innovation driven, clinical value oriented
With the coordinated implementation of China's new drug review and approval policies, the review and approval of new drugs will be comprehensively accelerated in 2021, and the number of new drugs approved will reach a record high. The following figure (chart 2) shows the number of innovative drugs approved and registered by FDA and nmpa from 2015 to 2021.
Figure 2: innovative drugs approved and registered by FDA nmpa from 2015 to 2021
Source: FDA, nmpa, frost Sullivan
In November 2021, the drug evaluation center (CDE) of the State Food and Drug Administration issued the guiding principles of clinical value oriented clinical research and development of antitumor drugs, which implemented the research and development concept of clinical value oriented and patient-centered from the perspective of patient needs, promoted the scientific and orderly development of antitumor drugs and promoted medical innovation to a new level. The development direction of China's local biomedical enterprises that independently research and develop innovative products is becoming more and more clear, and they need to actively develop innovative products that can optimize their own product pipelines. The competition of clinical efficacy homogenized products will move from the market stage to the clinical stage. The innovation and research level of local pharmaceutical enterprises is expected to be improved in training, and China's drug research and development will advance to a more open innovation stage.
2) Industry position of the company
Innovation is the core gene of Betta Pharmaceuticals Co.Ltd(300558) . The company has successfully developed China's first small molecule targeted anticancer drug Kemena with independent intellectual property rights and China's first domestic ALK inhibitor bemena; At the same time, the company has built a rich and gradient R & D pipeline through independent R & D and strategic cooperation. The company will unswervingly follow the path of innovation and fully promote the projects under research; Fully summarize and learn the new drug development experience of Kemena and bemena, meet the needs of experts and patients through academic promotion and real-world research, and promote the successful commercialization of products. (2) Main business of the company during the reporting period 1) main business and main products
The company is a national high-tech enterprise founded by Dr. returnees, focusing on the research and development of innovative drugs with independent intellectual property rights and integrating R & D, production and marketing. Since its establishment in 2003, the company has always kept in mind the mission of "better medicine, better life" and is committed to the research, development and promotion of new drugs to solve the unmet medical needs in the treatment of malignant tumors such as lung cancer.
By the end of the reporting period, the annual sales of the company's star product Kemena had exceeded RMB 1 billion for six consecutive years, with a cumulative sales of more than 10 billion; The second product, bemena, was approved for listing at the end of 2020, and the third product, beantin, was approved for listing at the end of 2021. The details of the three listed products are as follows.
·Kemena, the first postoperative adjuvant targeted oral drug for lung cancer listed in the medical insurance catalogue
In June 2021, Kemena's indications for postoperative adjuvant therapy were approved for listing and successfully included in the national catalogue of drugs for basic medical insurance, work injury insurance and maternity insurance (2021) (hereinafter referred to as the "national catalogue of medical insurance (2021)"), becoming the world's first and only generation of EGFR-TKI for postoperative adjuvant therapy for patients with early lung cancer, helping to further expand Kemena's market coverage, Consolidate the leading position of Kemena in China's lung cancer targeted drug market.
As an "extraordinary TKI", Kemena has created eight "firsts": China's first small molecule targeted anticancer drug with completely independent intellectual property rights, breaking the monopoly of imported drugs; The first generation EGFR-TKI for postoperative adjuvant therapy of non-small cell lung cancer in China; The first Chinese innovative drug selected in the international new drug R & D report; The first chemical innovative drug to win the first prize of the national scientific and technological progress award; The first domestic innovative drug to enter the national medical insurance catalogue through the national drug price negotiation in 2016 and actively reduce the price by 54%; China's innovative drugs with the first number of published academic articles and influencing factors; The first domestic innovative drug to carry out follow-up free drug use; The first independent innovative drug with annual sales of more than 1 billion yuan. In addition, Kemena has also won many honors and awards, such as the China Patent Gold Award (twice) jointly issued by the State Intellectual Property Office and the world patent organization, the "Oscar" - China industry award in Chinese industry, People.Cn Co.Ltd(603000) and the most clinically valuable innovative drug award jointly issued by the China Council for the promotion of drugs, being selected into the 70 years of health events in New China It appeared at the 2021 service trade fair and the national "13th five year plan" scientific and technological innovation achievement exhibition.
After 10 years of listing, "extraordinary TKI" Kemena has broken the import monopoly, cut through thorns and thorns all the way, guided the market with academia, and firmly occupied a leading position in similar products with the following characteristics. A. High efficiency and low toxicity make patients benefit for a long time
Over the years, Kemena has accumulated a large number of clinical evidence-based medical evidence, fully proved its high efficiency and low toxicity, and won the recognition of experts and patients. After taking Kemena, the incidence of common adverse reactions (rash and diarrhea) and liver toxicity were significantly lower than those of imported drugs. Under the trend of increasing survival time of lung cancer treatment, patients need to have quality long-term survival and have higher requirements for drug safety. Under this demand, Kemena will be a reliable choice for patients. At the same time, Kemena has carried out free medication projects for a long time, so the cost of patients taking Kemena for a long time can be reduced.
By the end of the reporting period, Kemena had benefited 320000 patients with advanced lung cancer, including nearly 3200 patients who took Kemena for more than five years. B. Extraordinary TKI, we are different
The company has formulated Kemena's positioning of "extraordinary TKI, we are different" and established a good brand image in the market. In the 10 years since its listing, the company has established a series of distinctive academic brand activities and continued to carry out clinical research among patients. So far, there have been more than 90 clinical studies related to Kemena, and more than 200 SCI papers (including 9 papers with more than 10 influencing factors) have been published, with a total influencing factor of more than 800 points, which fully verified the efficacy and safety of Kemena in different applications, such as:
a. The consultation study confirmed the effectiveness of Kemena in the first-line treatment of patients with EGFR mutation positive NSCLC. The results showed that the efficacy of Kemena was significantly better than cisplatin / pemetrexed and pemetrexed maintenance therapy. The results were published in the annals of oncology. This study established the first-line treatment status of EGFR-TKI in patients with EGFR mutant NSCLC.
b. The clinical research results of Kemena combined with chemotherapy in the first-line treatment of patients with sensitive EGFR mutant advanced lung adenocarcinoma show that in the first-line treatment, Kemena combined with chemotherapy can improve the PFS of patients, and the adverse reactions can be tolerated and managed. The research results were published in full in lung cancer.
c. Brain study is the only phase III clinical study in China to compare EGFR-TKI and whole brain radiotherapy head-to-head in patients with brain metastases. The results show that Kemena is significantly better than whole brain radiotherapy for patients with more than 3 brain metastases with EGFR mutation lesions. Brain study makes Kemena be listed as the preferred recommended drug for the treatment of brain metastasis in Chinese patients with EGFR mutant NSCLC. Brain's research results were published in the lancet respiratory medicine.
d. The increase research results show that Kemena can achieve the same curative effect as the conventional dose in the treatment of patients with 21-l858r mutation. It once again proves the innovative value and difference of Kemena, an independent innovative drug. At the same time, it also shows the importance of carrying out targeted research in different patient groups. It is believed that it will bring new treatment options to more 21-l858r mutant lung cancer patients in China. The research results were published in the international famous oncology journal Clinical Cancer Research.
e. The event study is the registered phase III clinical study of Kemena for adjuvant therapy after surgery in patients with non-small cell lung cancer with early EGFR gene sensitive mutation. It is the only registered clinical study in the field of postoperative adjuvant therapy of NSCLC in China with head-to-head comparison between EGFR-TKI and standard chemotherapy. The company reported the new indications of Kemena for postoperative adjuvant treatment of NSCLC patients with EGFR gene sensitive mutation with the concept study, and was approved for listing in June 2021. In July, the research results were published in the lancet respiratory medicine.
Through a series of academic research, the company continues to tap Kemena's clinical advantages, meet various clinical needs, consolidate Kemena's differentiated competitive advantages, and continuously improve the recognition of Chinese experts and patients for the company's products. Kemena "extraordinary TKI, we are different
