The Zhitong Finance App learned that recently, Citeline, a world-renowned consulting agency, released the white paper “2024 Pharmaceutical R&D Annual Review 2024” (Pharma R&D Annual Review 2024) and selected the world's top 25 pharmaceutical companies. Fosun Pharmaceutical (02196) was selected for the third year in a row, ranking 17th, up 7 places from the previous year.

The white paper shows that in 2023, the scale of the global new drug development pipeline reached a new high. China is continuously consolidating its position in the world's second-largest new drug development market, and the gap in the number of innovation pipelines between Chinese and US pharmaceutical companies is narrowing. As an innovation-driven global medical and health industry group, Fosun Pharmaceutical has always insisted on innovation as the core driving force for enterprise development for 30 years, and has continued to enrich the innovative product pipeline through an open and global innovation model of independent R&D, cooperative development, license introduction, and deep incubation.

By the end of 2023, Fosun Pharmaceutical was mainly developing more than 70 new drug and biosimilar projects (based on indications). Core treatment areas focus on tumors (solid tumors, hematomas), autoimmunity, central nervous system, chronic diseases (liver disease/metabolism/nephropathy), etc., and focus on the four core technology platforms of small molecules, antibody/ADC, RNA and cell therapy, to create an open and global innovative R&D system, and actively explore the layout of cutting-edge technologies such as tumor vaccines and AI drug development, and continuously enhance core R&D capabilities and pipeline value to promote more FIC (first-in-class, i.e. first-in-class) and BIC (best-in-class, best-in-class) Product development and commercialization.

In 2023, 8 indications of Fosun Pharmaceutical's 6 innovative drugs and 29 generic drug types (including import registration, excluding 13 generic drug formulations approved by Gland Pharma) were approved for marketing; 5 innovative drugs/biosimilar drugs had 7 indications and 64 generic drug types (including import registration, but not including Gland Pharma's overseas declaration items) were declared for listing; in addition, a total of 20 innovative drugs/biosimilar projects approved by clinical trials (calculated based on indications). There are 206 patent applications in the pharmaceutical sector, including 5 US patent applications and 11 PCT applications; 74 invention patent authorizations have been obtained.

R&D achievements accelerate and revenue from innovative products maintains rapid growth

In 2023, Fosun Pharmaceutical invested 5.937 billion yuan in R&D, an increase of 0.88% over the previous year; of these, R&D expenses were 4.346 billion yuan, an increase of 1.02% over the previous year. By the end of 2023, Fosun Pharmaceutical had more than 3,400 R&D personnel, of which more than 1,800 had master's degrees or above.

In recent years, along with continuous investment in innovative research and development, Fosun Pharmaceutical's innovative R&D achievements have been realized at an accelerated pace, and breakthroughs have been achieved in various fields from 0 to 1, helping the domestic medical and health industry continue to develop with high quality.

By the end of 2023, Fosun Pharmaceutical had independently developed and marketed the first biosimilar drug in China, Hanlikon (rituximab injection); the joint venture Fosun Kate's first CAR-T drug, Yikaida (acylenxide injection), was marketed domestically to fill gaps in the domestic market. In June 2023, Yikaida was also approved for additional second-line indications, which will benefit more patients with ineffective or recurrent first-line immunochemotherapy.

The first self-developed innovative biopharmaceutical anti-PD-1 monoclonal antibody Hans form (ES-SCLC) became the world's first approved targeted PD-1 monoclonal drug for first-line treatment of extensive small cell lung cancer (ES-SCLC). In addition, slulizumab injection (PD-1 inhibitor) has also been approved by the Indonesian Food and Drug Administration (BPOM) to treat extensive small cell lung cancer (ES-SCLC). This is the first time this product has been approved for marketing in overseas markets, and the first time it has been approved for marketing in Southeast Asian countries Produces PD-1 monoclonal antibodies.

In 2023, revenue from key varieties including Hans form (slulilizumab injection), injectable trastuzumab (trade name in China: Han Quyou), and Sukexin (avatripopa maleate tablets) continued to grow rapidly.

A variety of research pipelines are rapidly advancing to cover the three core markets of China, the US, and Europe

Currently, many of Fosun Pharmaceutical's research pipelines are progressing rapidly. In 2023, a total of 7 indications for 5 products independently developed, co-developed and approved by Fosun Pharmaceutical entered the pre-marketing approval stage.

Among them, the marketing license application (MAA) for slulizumab injection (PD-1 inhibitor) was accepted in the European Union, and the marketing registration application for first-line treatment of non-squamous non-small cell lung cancer (nsNSCLC) with the 5th indication of the product was also accepted by the China Drug Administration. The self-developed injectable trastuzumab (Chinese product name: Han Quyou) for breast cancer has been accepted by the US FDA, and is expected to become the first domestically produced biosimilar approved in China, the European Union, and the US, further covering the mainstream biopharmaceutical market in Europe and the US. In April 2024, FCN-159, a MEK1/2 selective inhibitor independently developed by Fosun Pharmaceutical, will be included in the priority review. The target indication is the treatment of adult dendritic cell and histiocytic tumors.

Fosun Pharmaceutical approved the introduction of the innovative fixed-point antibody conjugate drug FS-1502 (recombinant HER2 humanized monoclonal antibody monomethyl orostatin F conjugate agent for injection) to treat HER2-positive locally advanced or inoperable breast cancer in China to initiate phase III clinical research in China.

At the same time, Fosun Pharmaceutical continues to promote the development and industrialization of vaccines in the pipeline. In April 2023, Fosun Pharmaceutical independently developed a 13-valent pneumococcal conjugate vaccine and completed phase III clinical enrollment. In March 2024, the freeze-dried human rabies vaccine (Vero cells) independently developed by Fosun Pharmaceutical was approved for marketing in China.

In addition, applications for the marketing of various products under development, including daxibotulinumtoxina botulinum toxin (project code: RT002), tenapanol hydrochloride tablets (project code: Tenapanor), and the injectable filler product Profhilo (i.e. sodium hyaluronate solution for injection) were accepted by the State Drug Administration.

In the future, Fosun Pharmaceutical will always be patient-centered, continue to increase innovation investment around unmet clinical needs, efficiently promote the development and transformation of the world's leading technology and innovative products, actively explore and promote the transformation of innovative achievements at the source, and strive to become a first-class enterprise in the global healthcare market and lead the high-quality development of the pharmaceutical industry.