– Innovative R&D Yields Fruitful Results Once Again, Revenue Rises to RMB6.13 Billion
– Adjusted Non-HKFRS Profit Attributable to the Owners of the Parent up 14.0%
– New Products Boost Performance Associated Revenue up 39.6%
Development Highlights
– During the reporting Period, four of the Group’s innovative products were approved for marketing by the National Medical Products Administration of China (“NMPA”), namely Andewei (Benmelstobart Injection), Anboni (Unecritinib capsules), Anluoqing (Envonalkib capsules) and Beilelin (Liraglutide Injection), three of which are national category 1 innovative drugs.
– In the first half of 2024, the Group’s revenue from innovative products reached RMB 6.13 billion, a year-on-year increase of 14.8%. In addition to innovative products, the Group has 11 generic drugs approved by the NMPA for market launch. The overall revenue of generic drugs achieved positive growth in the first half of 2024. New products are an important driver of the Group’s revenue growth. In the first half of 2024, the Group’s revenue from new products launched within five years reached RMB 6.03 billion, representing a year-on-year increase of 39.6%.
– As of 30 June 2024, the Group had a total of 43 innovative drug candidates in the field of oncology, 8 innovative drug candidates related to the respiratory system, 6 innovative drug candidates related to liver disease, and 4 innovative drug candidates in the field of surgery/analgesia in the process of clinical trial application or above. Of these, 3 innovative oncology drug candidates and 1 innovative surgery/analgesia drug candidate are in the marketing application stage, and 5 innovative oncology drug candidates, 1 innovative respiratory system drug candidate, 1 innovative liver disease drug candidate, and 1 innovative surgery/analgesia drug candidates are in Phase III clinical trials. In addition, the Group had a total of 18 biosimilar or generic drug oncology candidates, 3 additional biosimilar or generic liver disease drug candidates, 21 biosimilar or generic respiratory system drug candidates, and 10 biosimilar or generic surgical/analgesic drug candidates in the clinical trial application or above.
– Focus V (Anlotinib Hydrochloride Capsules) is a new type of small molecule multi-target tyrosine kinase inhibitor. In February and July 2024, for anlotinib in combination with benmelstobart, two marketing applications were submitted to the Center for Drug Evaluation (“CDE”) of NMPA for the treatment of second- and third-line endometrial cancer, and first line renal cell carcinoma, respectively. In July 2024, the Phase III clinical study of anlotinib in combination with chemotherapy for the first-line treatment of advanced soft tissue sarcoma achieved positive results. The Group has submitted the marketing application and received acceptance for the new indication.
– Yilishu (Efbemalenograstim Alfa Injection) was approved in May 2023 for the prevention and treatment of neutropenia in cancer patients taking chemotherapy drugs. In December 2023, Efbemalenograstim alfa was successfully included in the National Reimbursement Drug List (“NRDL”), and its sales volume accelerated in the first half of 2024, becoming an important contributor to the Group’s revenue growth.
– Andewei (Benmelstobart Injection) is a humanized PD-L1 monoclonal antibody that was approved by the NMPA in April 2024 for use in combination with anlotinib, carboplatin, and etoposide in the first-line treatment of extensive-stage small cell lung cancer.
– Anboni (Unecritinib Fumarate Capsules) is a small molecule inhibitor of tyrosine kinase ROS1/ALK/c-Met, which was approved by the NMPA in April 2024 for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer. It is the first domestically produced targeted drug approved for the treatment of ROS1-positive non-small cell lung cancer.
– The clinical trial application of Lanifibranor was submitted to and accepted by CDE in March 2023. In July, Lanifibranor was included in the list of breakthrough therapeutics. Currently, Lanifibranor is conducting Phase III clinical trials globally and is actively advancing the enrollment of subjects. Lanifibranor is China’s first oral MASH drug to enter Phase III clinical trials and is expected to fill the gap in China’s MASH market.
Sino Biopharmaceutical Limited (Sino Biopharmaceutical or the Company, together with its subsidiaries, the Group) (HKG: 1177), a leading innovation-driven pharmaceutical conglomerate in the PRC, has announced its unaudited interim results for the six months ended 30 June 2024 (the Period).
During the Period, the Group recorded revenue of approximately RMB15.87 billion, a year-on-year increase of approximately 11.1%. Profit attributable to owners of the parent company was approximately RMB3.02 billion, a year-on-year increase of approximately 139.7%. Earnings per share attributable to owners of the parent company were approximately RMB16.39 cents. The significant year-over-year increase in profit attributable to owners of the parent company was mainly due to the gain on disposal of subsidiaries under discontinued operations during the current Period. Adjusted non-HKFRS profit attributable to the owners of the parent was approximately RMB1.54 billion, a YOY increase of approximately 14.0%. The Group’s liquidity remains strong, with cash and bank balances classified as current assets of approximately RMB8.55 billion, bank deposits classified as non-current assets of approximately RMB9.18 billion, and wealth management products of approximately RMB4.61 billion in total, and total fund reserves amounting to approximately RMB22.34 billion at the end of the Period.
The Board of Directors has recommended an interim dividend payment of HK3 cents per share (1H2023: HK2 cents).
Sales: Entering harvesting of innovative results period and sales revenue from generic products further rises
Always placing utmost importance on research and development (“R&D”), the Group leverages in-depth research and development to achieve significant benefits. At present, the Group has entered the harvest period of its innovative development, driving further growth in sales revenue. During the Period, sales of oncology drugs increased by 19.5% year-on-year to approximately RMB5.36 billion, accounting for approximately 33.8% of the Group’s revenue. Sales of surgical/analgesic medications increased by 29.9% year-on-year to approximately RMB2.58 billion, accounting for approximately 16.3% of the Group’s revenue. Sales of liver disease drugs amounted to approximately RMB2.03 billion, accounting for approximately 12.8% of the Group’s revenue. In addition, the sales contributions of products in various areas such as respiratory system, cardio-cerebral vascular medicines, and others increased simultaneously, accounting for approximately 11.2%, 8.6%, and 17.3% of the Group’s total revenue, respectively.
In the field of respiratory system, The Group has taken a series of proactive management measures in a timely manner, including strengthening downstream channels, expanding market coverage and conducting secondary development in markets outside the scope of the volume-based procurement (VBP), enabling Tianqing Suchang’s sales to achieve steady growth during the Period. In the meanwhile, the Group continued to expand its market coverage through active academic promotion, and Tianyun’s sales grew rapidly during the Period.
In the field of surgery/analgesia, the Group focuses on the development of high-potential areas, further expanding its market coverage and gradually increasing its production capacity to meet the booming market demand. Sales of flurbiprofen cataplasms have maintained a growth trend in recent years and achieved breakthrough growth during the Period.
R&D: R&D as the core for driving the Group’s continuous innovation and development
The Group has continued to focus its R&D efforts on new medicines in the four therapeutic areas of oncology, liver disease, respiratory system and surgery/analgesia. As at the end of the reporting Period, the Group had 76 innovative products in development, including 46 oncology products, 6 liver disease products, 9 respiratory system products, 5 surgery/analgesia products, and 10 other products. In addition, the Group had 65 generic drug products in development.
The Group has always put R&D at its core, and has continuously improved its R&D capabilities and speed by embracing the R&D concept of combining independent innovation, collaborative development, and the development of both innovative and generic drugs. It considers R&D as the foundation of its sustainable development. In the first half of 2024, it incurred R&D expenses of approximately RMB 2.58 billion, accounting for approximately 16.2% of the Group’s revenue. It is expected that the number of innovative products launched to the market will reach 25 by 2026. This will further strengthen the Group’s dominant position in the four main therapeutic areas and provide strong impetus for long-term sustainable growth.
Prospects: Keep up with national development strategy and accelerate globalization process
The pharmaceutical industry has become one of the fastest growing and most promising fields in China and even the world. As the world’s second largest pharmaceutical market, China’s demand for medical and healthcare products has grown rapidly in recent years, with breakthroughs being made in biotechnology. Innovation has become a new driving force for the high-quality development of China’s pharmaceutical industry. The Group has been closely monitoring the development of the country, society and the industry, and has continuously optimized its development strategy. Under the four main strategies of “organizational integration, comprehensive innovation, internationalization, and digitalization”, the Group will actively innovate its organizational structure, comprehensively improve its operational efficiency, focus on the innovation and development of the four main therapeutic areas of oncology, liver disease, respiratory system, and surgery/analgesia, and actively accelerate the global deployment of its business.
The Group is committed to its mission of becoming a “leading global pharmaceutical company through delivering innovative therapies for patients”. It strives to promote innovative development through its dual engines of internal R&D and business development. Over the years, the Group has stepped up its R&D investment and built strong internal R&D capabilities. At the same time, it has vigorously promoted business development and strategic cooperation, striving to become the best partner for global pharmaceutical and biotechnology enterprises. In April 2024, the Group entered into a strategic partnership with Boehringer Ingelheim to bring Boehringer Ingelheim’s innovative cancer therapies to the Mainland Chinese market. This move not only demonstrates The Group’s innovative strength in the pharmaceutical field, but also reflects its far-reaching influence in international cooperation.
Looking ahead, The Group will adhere to its dual-pronged approach in the implementation of its globalization strategy. Through this approach, the Group will bring global pharmaceutical innovations to China to benefit Chinese patients, and also go global and open up new markets to accelerate the satisfaction of unmet clinical needs worldwide.