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Highlights
On the evening of April 26, Sinovac Pharmaceutical (688136. SH) released its 2023 annual report and 2024 first quarter results. In the first quarter of 2024, the total operating income was 361 million yuan, a year-on-year increase of 11.79%, and the net profit attributable to the parent company was 12.4 million yuan, a year-on-year increase of 241%, and the performance "turned red".
Since the second half of 2023, the company's overseas process of many imported products has been significantly accelerated, and it has successively accepted and passed a number of overseas GMP on-site inspections, and infliximab has also achieved its first overseas sales.
The market share of the four core products continued to increase
On the evening of April 26, Sinovac Pharmaceutical released its 2023 annual report and 2024 first quarter performance report.
In 2023, Sinovac Pharmaceutical's main business will be stable and upward, the market share of the company's core products will still maintain a strong momentum of development during the reporting period, and the "blood supply" in the rear will be stable and progressive, which is inseparable from the company's increasingly perfect marketing system. As of the end of 2023, the company's terminals cover about 22,700 hospitals of all levels, primary medical institutions, pharmacies, etc., an increase of about 2,700 from the end of the previous year, including more than 7,500 hospitals, more than 10,700 third terminals, and about 4,500 pharmacies.
In the first quarter of 2024, Sinovac Pharmaceutical's performance optimization results were remarkable, and the development situation was bright, achieving a total operating income of 361 million yuan, a year-on-year increase of 11.79%, and a net profit attributable to the parent company of 12.4 million yuan, a year-on-year increase of 241%. This is mainly due to the significant growth rate of the company's product shipments, the sharp increase in domestic sales of its own products, and the acceleration and efficiency of internal management and R&D.
At present, Sinovac Pharmaceutical's main products cover three major drug types: biological drugs, chemical drugs, and Chinese patent medicines, involving antiviral, digestive and autoimmunity, anti-tumor and metabolic diseases and other therapeutic fields, and the core products include human interferon α1b (Serojin ®), human erythropoietin (eprodine ®), human granulocyte stimulating factor (Bai Texi ®), Clostridium butyricum double live bacteria (Chang Lekang ®), exclusive Chinese patent medicine Kehuang capsules, etc.
Human interferon α1b for injection is the first genetically engineered innovative drug in China, which has been included in the national medical insurance category B and the national basic drug list, and is widely used in viral diseases such as hand, foot and mouth disease, bronchiolitis, and herpangina. According to the data of Minenet, in recent years, in the terminal recombinant human interferon α-1b (human interferon α-1b) brand competition pattern in China's urban public hospitals, county-level public hospitals, urban community centers and township health centers (hereinafter referred to as China's public medical institutions), Sairuojin ® has ranked first, and its market share has increased year by year, and its leading position is stable.
Epudine ® is a national medical insurance class B and a national basic drug species, which has the functions of promoting the expansion and differentiation of erythroid colony-forming units in the bone marrow, inhibiting apoptosis, and increasing the number of red blood cells. In recent years, the sales of terminal recombinant human erythropoietin (recombinant human erythropoietin and human erythropoietin) in China's public medical institutions have exceeded 3 billion yuan, of which epudine ® ranks second in the market, and its market share has increased year by year, from about 13% in 2020 to about 16% in the first half of 2023.
Sales of terminal epudine ® in China's public medical institutions in recent years (unit: 10,000 yuan)
Source: Minenet's competitive landscape of drug terminals in China's public medical institutions
Bai Texi ® is a short-acting whitening drug, which is a national medical insurance class B variety. According to data from Minenet, the market size of terminal baiyao in China's public medical institutions will exceed 9 billion yuan in 2022. In the competitive landscape of filgrastim (recombinant human granulocyte colony-stimulating factor, recombinant human granulocyte-stimulating factor, human granulocyte-stimulating factor), Bitexi's ® ranking has risen from seventh in 2020 to fifth in the first half of 2023, and its market share has increased from 4% to about 6%.
In recent years, the sales of terminal Bai Texi ® in China's public medical institutions (unit: 10,000 yuan)
Source: Minenet's competitive landscape of drug terminals in China's public medical institutions
In recent years, Sinovac Pharmaceutical has actively carried out product introduction and continuously expanded its product line. Among the products introduced by the company, a number of them have been approved for marketing and commercialization in China, among which infliximab (class stop ®) introduced from Mabptech is the first approved infliximab biosimilar in China. In recent years, the sales of terminal infliximab in China's public medical institutions have increased year by year, exceeding 1 billion yuan in 2022 and is expected to reach a new high in 2023. Since Kexing won ® the exclusive promotion right of the Chinese mainland market in 2022, with its own three-dimensional marketing network and professional academic promotion capabilities accumulated for many years, the market share of the class suspension ® has increased year by year, and the market ranking has jumped to second place in the first half of 2023. It is worth mentioning that in ® 2024, the first overseas sales have been realized, and the market space is expected to be further opened.
Sales of terminal infliximab in China's public medical institutions in recent years (unit: 10,000 yuan)
Source: Minenet's competitive landscape of drug terminals in China's public medical institutions
A total of 13 products have been introduced!
In recent years, the relatively low barriers to domestic Fast Follow have led to "R&D piling", and at the same time, the price reduction of medical insurance negotiations has continued to squeeze profit margins, and "going overseas" has become an important way for domestic pharmaceutical companies to seek greater development space.
After more than 20 years of development, the company has established a relatively complete and mature overseas commercialization system, with rich comprehensive capabilities in product registration, market expansion and marketing, GMP compliance audit and other aspects.
Aiming at overseas emerging markets is Sinovac Pharmaceutical's unique way to "go overseas". At present, the company's overseas sales network has covered 100% of the emerging markets with a population of more than 100 million and the top 30 in GDP, and has established a solid and long-term cooperation with more than 100 customers.
Under the boom of domestic pharmaceutical companies "going overseas", Sinovac Pharmaceutical firmly implements the "internationalization" strategy, actively carries out product introduction, continuously expands product lines, and continues to provide product support for overseas commercialization strategies.
Since 2024, Sinovac Pharmaceutical has successively signed cooperation agreements with Xilingyuan Pharmaceutical, Yabao Biotechnology, Chia Tai Tianqing Pharmaceutical, and Qingfeng Pharmaceutical, and obtained the exclusive commercialization rights and interests of eribulin mesylate injection in 36 countries, the exclusive agency qualification of the first batch of 10 countries for sorafenib tosylate tablets, the commercialization rights and interests of the first batch of 11 overseas countries for palbociclib capsules, and the commercialization rights and interests of the first batch of 10 overseas countries for olaparib tablets.
Up to now, the company has introduced a total of 13 products, covering anti-tumor, autoimmunity, metabolism and other therapeutic fields, mainly for overseas emerging market countries, and relying on albumin paclitaxel to extend to the mature market of the European Union.
In the field of breast cancer, Sinovac Pharmaceutical has formed a complete product matrix, and has successively introduced a number of blockbuster products such as nab-paclitaxel, trastuzumab, bevacizumab, neratinib, eribulin, and palbociclib. Among them, nab-paclitaxel is the first product introduced by the company, and it is also a major "breakthrough" for the company to extend to the market of high-standard regulations. The product successfully completed the on-site inspection before EU GMP approval in February this year, and has completed the signing of cooperative customers in 35 countries including Europe, the Middle East and North Africa and South America. In the EU market, albumin paclitaxel is currently only sold by the original manufacturer BMS and the generic drug company TEVA, which has a good competitive pattern.
In the field of autoimmunity, Sinovac Pharmaceutical has successively introduced infliximab and adalimumab. Since 2023, infliximab has successively received GMP on-site audits from the Indonesian Ministry of Health BPOM, Brazil's ANVISA, and the Egyptian Food and Drug Administration, and has now achieved its first overseas sales, and adalimumab has been subject to the on-site GMP audit of the Egyptian Food and Drug Administration. More than 40 countries and regions, including Indonesia, have achieved market access and sales, and in addition, sevelamer carbonate tablets for the treatment of hyperphosphatemia in patients with chronic kidney disease have been introduced.
Up to now, Sinovac Pharmaceutical has signed contracts with customers in more than 40 countries for the introduction of 13 products and has successively submitted registration applications for the introduced products, and a number of products such as infliximab, bevacizumab, and nab-paclitaxel have completed on-site audits in Egypt, Brazil, Indonesia, the European Union and other countries, and are expected to achieve overseas sales in 2024.
The 6 new drugs under development are being promoted efficiently, and the multi-point flowering is full of highlights
In addition to continuing to increase overseas business, R&D and innovation are also an important development strategy of Sinovac Pharmaceutical, and the company has always adhered to the R&D layout and investment, focusing on antiviral, oncology, immune and degenerative diseases and other fields, and constantly improving the product R&D pipeline.
According to the data of Minenet, Sinovac Pharmaceutical currently has 6 new drugs in the clinical application stage and above in China (excluding terminated projects), among them, SHEN26 capsule (RdRp inhibitor) has completed clinical phase III, human interferon α1b inhalation solution phase III clinical trial has completed the enrollment and administration of the first subject, pegylated human granulocyte stimulating factor injection has completed phase I clinical trial, and GB08 injection (FC long-acting growth hormone) clinical application has been accepted.
Sinovac Pharmaceutical has new drugs under development in China
Source: Minenet Integrated Database
Human interferon α1b inhalation solution is a special drug for children, which is administered through nebulization, which has the advantages of fast onset, high patient tolerance and high safety, and is expected to become the first batch of symptomatic drugs for the treatment of respiratory syncytial virus (RSV) infection in children in China. If the product is successfully approved, it will develop synergistically with the company's listed Serojin ® and consolidate the company's leading position in the field of antivirals.
According to the Global Burden of RSV Disease Study in Children published by The Lancet, there were 33 million cases of acute lower respiratory tract infections caused by RSV infection in children under 5 years of age in 2019, and about 3.5 million cases of RSV acute lower respiratory tract infections in children under 5 years of age in mainland China in 2019, accounting for more than 10% of the world's total.
In addition, from the latest R&D pipeline disclosed in the annual report, it can also be seen that Sinovac is determined to R&D and innovation. Grasp the product with one hand and commercialization with the other hand, with a clear strategy and a clear path. And with the gradual realization of Sinovac Pharmaceutical's goal of "China's most valuable overseas platform for high-quality drugs", the brand value will be further released.
Sources: Minenet database, company announcements, etc
Note: The statistical scope of "Drug Terminal Competition Pattern of China's Public Medical Institutions" by Minenet is: China's urban public hospitals, county-level public hospitals, urban community centers and township health centers, excluding private hospitals, private clinics and village clinics, and the above sales are calculated based on the average retail price of products at the terminal. The statistics are as of April 28, if there is any omission, please correct!