CSPC Pharmaceutical Group has achieved significant milestones in research and development, securing conditional approval for its self-developed Class 1 new drug, Enlansub, and for the injectable version of Rayzoprazole. The company has also received approval for clinical trials in the U.S. for its antibody-drug conjugate, clinical trial approval for its mRNA vaccine against respiratory syncytial virus, and clinical trial approval for the first CAR-T cell injection based on mRNA-LNP technology. As an innovation-driven enterprise and a key player in the national industrial chain, CSPC continues to enhance its R&D investments, elevate its international influence, and fortify its product competitive edge. This year, various in-development drugs have reached key progress points, with some approved for market launch or clinical trials both domestically and internationally. Currently, CSPC is conducting over 130 innovative drug projects, with more than 50 new drugs expected to be launched in the next five years.

Comprehensive Market Coverage

CSPC was listed in Hong Kong in 1994 and is committed to developing innovative products that address unmet clinical needs, providing effective treatment options for patients. The company's business mainly consists of finished drugs, raw materials, functional foods, and other sectors.

According to CSPC's recently released half-year report for 2024, the company achieved revenues of 16.284 billion yuan in the first half of the year, with finished drug sales accounting for 13.549 billion yuan (over 83%), raw materials generating 1.855 billion yuan (about 11%), and functional foods and other businesses contributing 880 million yuan (about 5%). The finished drugs sector, especially innovative drugs, remains a focal point for the company’s future development.

CSPC's finished drug sector, particularly its neurology medications, continues to show stable growth. In the first half of the year, revenues from neuro-related therapies reached 5.236 billion yuan, accounting for 38.6% of the finished drug sector and representing a year-on-year increase of 15%.

Furthermore, the new products approved for sale each year provide substantial support for CSPC's performance growth. In the first half of this year, the company had seven varieties approved for market entry, including the Class 1 new drug Enlansub, a PD-1 monoclonal antibody for cervical cancer, and a modified Class 2 drug, recombinant human TNK tissue-type plasminogen activator, which has added acute ischemic stroke as a new indication.

CSPC not only boasts a rich product line but also has a formidable commercialization capability. The company has established a professional marketing team of over 10,000 people, ensuring extensive coverage across medical institutions nationwide. It is actively working to penetrate county-level markets and provide high-quality medicines to grassroots populations. Through patient-centric, clinically data-driven promotional activities, its sales team has successfully nurtured several core products that capture leading market positions.

Full-Chain Innovation Coordination

The research and development process for a new drug typically comprises project initiation, preclinical research, IND (Investigational New Drug application), clinical trials, NDA (New Drug Application), and market launch. The lengthy process, high costs, and very low success rates deter many companies from pursuing innovation. CSPC’s approach is to solidify the competitiveness of each phase, creating full-chain collaborative innovation from the initial drug molecule discovery to clinical testing and commercialization.

As a leader in the pharmaceutical industry's innovation and transformation, CSPC has formed an international R&D team of over 2,000 people, with key research centers located in Shijiazhuang, Shanghai, Beijing, and the U.S. It focuses on pivotal therapeutic areas such as oncology, psychiatry, cardiology, immunology, respiratory, digestive metabolism, and anti-infection. In terms of technology, the company has developed eight major innovation platforms in areas such as nanoformulations, mRNA, siRNA, antibody/fusion proteins, cell therapies, and ADCs (Antibody-Drug Conjugates) to bolster its innovative drug research.

CSPC's R&D investment continues to expand, with annual expenditures rising from 2 billion yuan in 2019 to over 4.83 billion yuan in 2023. In the first half of this year, R&D expenses reached 2.542 billion yuan, marking a year-on-year growth of 10.3%.

As of June 30 this year, over 60 key investigational drugs have entered clinical or submission phases, with seven already submitted for market approval. Notably, the fully human anti-PD-1 monoclonal antibody injection (SYSA1802) and Omazu monoclonal antibody (SYSA1903) are currently in the submission stage. The application for the Class 1 new drug "Ploglitazone Tablets" has also been accepted by the National Medical Products Administration.

CSPC is strategically entering high-potential markets like ADCs and GLP-1 (glucagon-like peptide-1) with several products in advanced development stages. In the ADC sector, CSPC has proprietary intellectual property with stable, uniform properties aided by enzyme-based point-conjugation technology. This advantage ensures that its ADC products perform well in efficacy and safety. Currently, at least six ADC products are in clinical trials, targeting popular sites like HER2, Nectin-4, Claudin18.2, and EGFR.

The market outlook for CSPC's GLP-1 drugs is promising. Institutions project that the GLP-1 drug market in China will reach 51.5 billion yuan by 2030, with rapid development expected. The company's Semaglutide injection has commenced phase III clinical research in China for Type 2 diabetes treatment and is now in the enrollment stage. Utilizing a chemical synthesis method, this product has lower impurity levels, with no global competitors using this synthesis method.

Additionally, CSPC's Semaglutide injection targets the GLP-1 receptor and has completed phase III trials for treating overweight and obesity. This drug is based on the hyFc long-acting fusion protein platform, designed to extend the half-life of GLP-1 in the body and potentially allow for weekly subcutaneous administration. Approvals for both Alzheimer's disease and non-alcoholic fatty liver disease indications have also been granted. These two drugs are expected to receive market approvals starting in 2026.

According to analysts at Great Wall Guo Rui Securities, speed is a priority for pharmaceutical companies in the GLP-1 market. Currently, the GLP-1 drug sector in weight loss is in its early stages with no established competitive landscape.

CSPC is also the first domestic enterprise to optimize the mRNA vaccine process, successfully integrating the entire supply chain from circular plasmids, linear plasmids, mRNA precursors to LNP delivery. This has laid a solid foundation for future research and development. Currently, CSPC has prophylactic and therapeutic mRNA vaccines targeting shingles virus (VZV), respiratory syncytial virus (RSV), and cancers under investigation.

Advancing Internationalization

In the wave of globalization, biopharmaceutical companies are prioritizing international expansion as a key strategy. Currently, CSPC is implementing a dual submission strategy for its innovative drugs in both China and the U.S. to expedite its internationalization process. In July, the Investigational New Drug (IND) application for CSPC's antibody-drug conjugate SYS602 was approved by the U.S. FDA, allowing clinical trials to commence in the U.S.; previously, the product had secured domestic clinical trial approval in March.

CSPC has seen abundant achievements in product licensing. In 2021, the company licensed the cancer drug "NBL-015" to the U.S. biopharmaceutical firm Flame Biosciences. Subsequently, in 2022 and 2023, its ADC products targeting Claudin18.2 (SYSA1801) and Nectin-4 (SYS6002) were authorized for external collaboration. Notably, CSPC’s Nectin-4 ADC was licensed to U.S. firm Corbus for nearly $700 million in total. Initial results indicate that this ADC has shown efficacy signals and good tolerance in advanced solid tumors such as cervical and urothelial cancers. This successful authorization marks international recognition of CSPC's innovation capabilities and serves as a significant milestone for the company’s proprietary products going global.

According to CSPC’s 2023 annual report, the company is accelerating its internationalization by establishing an international headquarters and an overseas formulations market division in Singapore. It aims to rapidly expand high-end complex formulations and biological agents like liposomes and monoclonal antibodies in markets such as Europe, the U.S., Japan, and South Korea. CSPC is enhancing its innovative capabilities and international competitiveness through technology introduction, product licensing, and joint R&D. This open cooperation approach helps CSPC better integrate into the global pharmaceutical industrial chain and innovation network. CSPC's products have been exported to over 110 countries and regions across Europe, Asia, and the Americas.

Source: https://finance.eastmoney.com/a/202409143183327544.html