Securities code: Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) securities abbreviation: Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) Announcement No.: 2022023 Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) 2021 annual report summary
1、 Important note: 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. In addition to the following directors, other directors attended the meeting of the board of directors to consider the annual report in person
Name of director not present in person position of director not present in person reason for not attending the meeting name of the entrusted person
Tips on non-standard audit opinions □ applicable √ not applicable to the profit distribution plan of common shares or the plan of converting accumulation fund into share capital in the reporting period considered by the board of directors √ applicable □ not applicable whether to convert accumulation fund into share capital □ yes √ no
The company’s profit distribution plan for ordinary shares reviewed and approved by the board of directors is: Based on the total number of 1114816535 shares of the company as of December 31, 2021 and the total share capital of 1093589012 shares after deducting 21227523 shares held in the company’s special securities repurchase account, the company will distribute cash dividends of 4.00 yuan (including tax) and bonus shares of 0 shares (including tax) to all shareholders for every 10 shares, and will not convert the accumulation fund into share capital. Between the disclosure date of the annual report and the equity registration date of the profit distribution plan, if the total number of shares participating in the dividend changes due to share repurchase and other matters, the total share capital of the company after deducting the repurchased shares from the total number of shares on the equity registration date when the future distribution plan is implemented shall be used as the base, and the distribution proportion shall remain unchanged and the total distribution amount shall be adjusted. Preferred stock profit distribution plan for the reporting period adopted by the board of directors □ applicable √ not applicable II. Basic information of the company 1. Company profile
Stock abbreviation Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) stock code Shenzhen Salubris Pharmaceuticals Co.Ltd(002294)
Shenzhen Stock Exchange
Contact person and contact information secretary of the board of directors securities affairs representative
Name: Yang Jianfeng
Office address: chegongmiao green, No. 6009, Shennan Avenue, Futian District, Shenzhen
37th floor, main building of King Plaza
Fax: 075583867338
Tel: 7883888655
E-mail [email protected].
2. Introduction to main business or products during the reporting period (1) industry of the company during the reporting period
2021 is the first year of China’s 14th five year plan. The global economy is still affected by covid-19 epidemic, and the economies and medical and health systems of various countries have been greatly impacted. Under the more complex political and economic situation, China is still in the best period of development, and people’s livelihood has received the greatest attention. The government leads the pharmaceutical industry to forge ahead under the repeated epidemic situation, embark on a new journey and move towards the world. During the reporting period, the pharmaceutical industry policies were issued intensively, and more than 200 key policies of the pharmaceutical industry were issued at the national level. Many policies have a significant impact on the development of the pharmaceutical field in the next few years: among them, the pharmaceutical policies account for about 58%, mainly including drug registration and approval, API, drug patent, drug warning and so on; Medical policies account for about 18%, mainly including long-term prescriptions, public hospital reform, graded diagnosis and treatment, medical and health service reform and the promotion of Sanming’s medical reform experience; Medical insurance policies account for about 19%, mainly including medical insurance catalog adjustment and negotiation, DRG / Dip payment method, medical insurance for urban and rural residents, etc. Through a series of policies, it can be seen that the main theme of China Meheco Group Co.Ltd(600056) field is still high-quality development, encouraging innovation, paying attention to credit and controlling fees.
China is a country with a large population. The data show that 75.8% of the elderly aged 60 and over are troubled by one or more chronic diseases. The death caused by chronic diseases accounts for 86.6% of the total death, and the disease burden exceeds 70% of the total disease burden. Therefore, there is a huge market demand for chronic disease drugs, and there is an urgent need to develop innovative drugs for chronic disease treatment to meet the needs of society and medical insurance.
Industry development from imitation to quality (consistency evaluation) and then to innovation is the right development path. There will always be many different voices in the process of change. At this time, we need to keep the original intention, turn complexity into simplicity and make a choice Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) ‘s vision is to provide high-quality and high-priced drugs for the society and patients, constantly develop new products with clinical value, meet unmet clinical needs and create a healthy life. Therefore, Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) in the next few years, it will still focus on the professional road of innovative product R & D and commercialization. (2) Main businesses of the company during the reporting period
The main business of the company and its subsidiaries involves the R & D, production and sales of drugs and medical devices. The main products and projects under research include cardiovascular drugs and medical devices, cephalosporin antibiotics and raw materials, orthopedic drugs, etc., covering the treatment fields of cardio cerebrovascular, hypoglycemic, orthopedics, anti-tumor, anti infection and so on.
The company insists on developing innovative and high-quality products with clinical value to meet the unmet clinical needs; By virtue of excellent evidence-based medical research and excellent product quality, create a professional and high-quality ” Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) ” brand image. Continuously explore and innovate, covering four cardiovascular fields (cerebrovascular, cardiovascular, cardiac entity and peripheral blood vessels) and six departments (Cardiology, cardiac surgery, neurology, neurosurgery, Nephrology and vascular surgery); Layout and implant interventional device products, realize the strategic coordination of drugs, devices and services, provide comprehensive treatment solutions for the majority of patients, and enhance the dominant position of comprehensive solutions in the field of cardio cerebrovascular.
The company’s main products are as follows:
1. The innovative product xinlitan (generic name of drug: alisartan axetil tablets) is used for the treatment of mild and moderate essential hypertension. The main specifications are 240mg / tablet and 80mg / tablet. In 2021, the national medical insurance catalogue was renewed through negotiation, and the national medical insurance class B drug was paid 4.3 yuan (240mg / tablet). Xinlitan is the only angiotensin II receptor antagonist antihypertensive drug independently developed by China and with independent intellectual property rights (class 1.1 new drugs). The patent protection period of the preparation is until 2028.
Its antihypertensive effect is faster and stronger, the antihypertensive effect is stable, does not depend on liver cytochrome P450 enzyme, and the combination of drugs is safer; It also has a unique effect of reducing uric acid. Long term use has a protective effect on target organs, which is recommended by the 2018 edition of China guidelines for the prevention and treatment of hypertension. In the target market of xinlitan – hypertension and chronic kidney disease, there are not only a large number of unmet clinical needs, but also market space outside of volume procurement. In addition, the newly listed innovative products are limited, and the competition pattern and market prospect are good.
According to its product characteristics and the latest medical development trend, the company has formulated the product life cycle management plan of xinlitan, strengthened the channel construction and promotion, and achieved good growth in recent years; Under the national policy of guiding and supporting innovation, actively participate in the medical insurance negotiation of the product, so as to lay the foundation for entering a broader grass-roots market.
In addition, around alisartan axetil, a class 1 new drug s086 (indications for hypertension and chronic heart failure), the first domestic ARB / CCB class 2 compound preparation sal0107 and ARB / diuretic class 2 compound preparation sal0108 are arranged. After these products are put on the market, they will cover different market segments and meet more unmet clinical needs.
2. Taijia (generic name of drug: clopidogrel bisulfate tablets) is the preferred drug for anti sectorlet aggregation and class B drug of national medical insurance. It is used in cardiology, cardiac surgery, vascular surgery, neurology, neurosurgery, geriatrics, etc.
3. Innovative device maurora ® (rapamycin drug-eluting vertebral artery stent system) is mainly used for the expansion of symptomatic extracranial vertebral artery stenosis. Maurora ® It is the first rapamycin drug loaded vertebral artery stent in the world. Rapamycin is applied to the treatment of cerebral vascular stenosis for the first time. Its unique high biocompatibility coating ensures the stable release of drugs and avoids adverse reactions. Compared with the current bare metal stents on the market, it has obvious effect in inhibiting the occurrence of restenosis after vascular stent implantation. It can prevent the recurrence of stroke caused by restenosis, reduce the risk of secondary intervention, improve the prognosis and improve the quality of life of patients.
5. The company actively participated in the national centralized purchase of drugs, and many products won the bid successively, which quickly opened the market and brought stable cash flow and operation improvement to the company.
During the reporting period, the company adhered to the good faith management, achieved the expectation in the project approval layout and clinical research and development of innovative projects, basically completed the set objectives in the medical insurance negotiation, bidding and sales of new products and generic drugs, and the operating revenue and net profit returned to the growth trend. The company achieved an annual operating revenue of 3.058 billion yuan, a year-on-year increase of 11.68%; The net profit attributable to shareholders of listed companies was 534 million yuan, a year-on-year increase of 776.90%.
In terms of R & D, the company continued to focus on innovative R & D and investment, greatly improved its independent innovation R & D capability, and rapidly enriched its product line; We have established and improved the construction of innovation team and early screening platform, strengthened the construction of small and large molecular teams, including clinical teams with complete systems such as early clinical, medical development, operation, data management and statistics, drug safety and quality assurance, and achieved initial results in the construction of innovative drug R & D system. The company has R & D bases in Shenzhen, Beijing, Chengdu and Maryland, and has a number of innovative drug R & D leading talents, forming a key talent echelon. At present, there are 639 R & D personnel, including 428 chemical medicine team and 127 biological medicine team.
According to the company’s development strategy and scientific layout, the research institute strictly evaluates innovative projects, improves the investment decision-making system, and strengthens the management of R & D product approval and M & a product evaluation and screening. At the same time, we will deepen our efforts in the field of chronic diseases (cardio cerebrovascular, Nephrology, osteoporosis, etc.), comprehensively improve the ability of innovative R & D and expansion, and pay attention to following up the R & D Progress of innovative products.
During the reporting period, the R & D investment was 691 million yuan, accounting for 22.61% of the revenue. The company submitted two new product ind applications and two new product listing applications to the drug administration; Three implied clinical licenses of drugs, two new product listing application acceptance notices, and 10 product registration approvals / supplementary application approvals / registration certificates were obtained. The two leading units of devices under research in clinical trials passed the review of the ethics committee and completed the filing of the drug administration. 37 patents were authorized, including 16 invention patents (including 3 in the United States, 1 in Japan, 1 in Canada, 2 in Australia and 1 in Taiwan), 21 utility model patents, 55 new invention patents (including 12 PCT invention patent applications) and 2 new utility model patents.
By the end of the reporting period, the company had 48 research projects, including 26 chemical drugs (including 21 innovation projects) and 15 biological drugs (including 10 innovation projects); There are 7 research projects in the field of medical devices.
Several R & D projects have made phased progress. So far, 260 cases of s086 (hypertension) phase III clinical trial have been enrolled, and s086 (heart failure) has held a phase III clinical trial kick-off meeting to prepare for enrollment; Sal0107 has completed the enrollment of all subjects according to the phase III clinical scheme, and will continue to carry out clinical follow-up in the follow-up; Sal0108 is about to hold a phase III clinical trial kick-off meeting to prepare for enrollment; The application for listing of new drug ennastat for renal anemia has been accepted and is under CDE review. Jk07 has obtained the qualification of phase I clinical trial of HFPEF (heart failure with preserved ejection fraction) indication for chronic heart failure by FDA. Meanwhile, the first group of phase I clinical trials of hfref (heart failure with reduced ejection fraction) indication in the United States have been unblinded and the enrollment of the second group of clinical trials is under way. The trial data of jk07 phase I clinical group I subjects (n = 5) preliminarily showed that jk07 had good safety and potential clinical benefit signals compared with the placebo group, and the absolute value of left ventricular ejection fraction improved by 18% (relative improvement greater than 50%) compared with the baseline. China’s phase I clinical trial has enrolled 3 cases. The company plans to increase clinical cooperative hospitals and increase the recruitment of subjects. The enrollment speed is accelerating.
During the reporting period, the implementation of the company’s non-public offering plan was completed. Ningbo Ronbay New Energy Technology Co.Ltd(688005) 35 new shares were issued in this non-public offering, with an issue price of 28.37 yuan / share, and the total amount of funds raised was 195187117795 yuan. After deducting various issuance expenses (excluding tax) of RMB 1980547402, the net amount of funds actually raised is RMB 193206570393, which provides sufficient capital guarantee for innovative R & D.
In terms of sales, further strengthen market access, academic promotion, brand construction and broad market construction. Grassroots and online market promotion; Actively participate in grass-roots medical training activities, strengthen cooperation with cardiovascular experts, improve the level of prevention and treatment of cardiovascular diseases at grass-roots level in China, provide a multi-point practice platform for high-level cardiovascular doctors, and further expand Shenzhen Salubris Pharmaceuticals Co.Ltd(002294) the brand influence.
Innovative product – “xinlitan”, which focuses on hospital channel promotion, supplemented by drugstores and e-commerce undertaking, has newly developed nearly 1000 hospitals, and has basically achieved the promotion goal in more than 3000 core hospitals across the country; At the same time, a new round of medical insurance negotiations was successfully completed at a price of 4.3 yuan (240mg / tablet), laying the foundation for entering a broader grass-roots market.
In terms of generic drugs, strive to win the bid for the products with volume procurement catalogue and continuously expand the sales channels. During the reporting period, five products won the bid for centralized procurement by countries: tegrilol tablets (Taiyi) ®） 60mg, cefuroxime sodium for injection (Xinlixin), lecardipine hydrochloride tablets (xindaping) ®）、 Benazepril hydrochloride tablets (xindayi) ®）、 Rivaroxaban tablets (10mg, 20mg) will bring stable cash flow and operation improvement to the company. In addition, to ensure the accessibility of Taijia in the grass-roots market, pharmacies and e-commerce platforms, “sales team + pharmacies + e-commerce + business cooperation” go hand in hand, make full use of resources and obtain market share other than centralized procurement. Xinfutai ® Without medical insurance,
