Recently, CSPC Innovation, the innovative drug platform under CSPC Pharmaceutical Group, released its 2025 annual performance forecast. The company expects a net loss attributable to shareholders of the listed company of RMB 170 million to RMB 255 million for the whole year, compared with RMB 53.73 million in 2024, turning from profit to loss.

However, its performance "turnaround" is not a simple business failure, but the result of a strategic choice to "gamble" on innovative drugs.

01

Behind the "face-changing" performance
According to the company's announcement, the expected loss is mainly driven by the following three factors.

The main reason for the losses was the massive R&D expenses, reaching 1 billion yuan. In fact, since acquiring control of Jushi Biosciences in 2024, CSPC Innovation's R&D expenses have increased significantly. In 2022, 2023, and 2024, CSPC Innovation's R&D expenses were 666 million yuan, 671 million yuan, and 843 million yuan, respectively, accounting for 23.5%, 26.4%, and 42.5% of revenue.

In 2025, CSPC Innovation continued to increase its R&D investment, and many of its products under development made significant progress.

The announcement shows that in 2025, the company obtained clinical trial approvals for four antibody drugs, six ADC products, and one mRNA vaccine for the first time, and two ADC products entered Phase III clinical trials. In addition, omalizumab received approval for a new indication, and the marketing application for pertuzumab was accepted by the NMPA.

In 2025, CSPC Innovation will continue to acquire 29% of Jushi Biosciences' equity , increasing its shareholding from 51% to 80%.

Jushi Bio is the core entity responsible for the research and development of the aforementioned innovative biological agents. Currently, it is still in a period of high-intensity R&D investment and has not yet turned a profit. With the increase in shareholding, Jushi Bio's losses will be more significantly consolidated into CSPC Pharmaceutical Innovation's consolidated financial statements. The company's decision to increase its stake at this time demonstrates its determination to deeply integrate with the core R&D platform, even if it exacerbates its own financial losses in the short term.

In addition, CSPC Innovation 's original "cash cow" business is also facing challenges.

Currently, CSPC Innovation's revenue mainly comes from the sales of functional raw materials and health foods, which account for approximately 90% of the company's revenue. Sales revenue in 2022, 2023, and 2024 were RMB 2.57 billion, RMB 2.45 billion, and RMB 1.84 billion, respectively.
Specifically, caffeine products are the main sales driver. According to Frost & Sullivan, from 2020 to 2024, CSPC Innovation maintained its position as the world's largest producer of chemically synthesized caffeine by both revenue and shipment volume. In 2024, the three major players in China's chemically synthesized caffeine market collectively held over 90% of the market share, with CSPC Innovation leading the market with a 51.5% market share.

However, in recent years, caffeine products have faced fierce competition in the market, resulting in lower gross profit margins and reduced profits.

The pressure on traditional business and the "cash burn" of innovative R&D have jointly led to the losses. However, the current "losses" of CSPC Innovation are essentially "strategic losses" for the future, and its future lies in whether the huge investment can be transformed into irreplaceable competitiveness.

02

Embarking on an Innovation "Long March"

CSPC Innovation was founded in 2006, formerly known as CSPC NewNuway Pharmaceutical Co., Ltd. In 2019, the company was listed on the Shenzhen Stock Exchange's ChiNext board, becoming the first Chinese red-chip company to be spun off and relisted on the A-share market, abbreviated as "NewNuway". At that time, the company focused on the research and development and production of high-quality caffeine, and through mergers and acquisitions, it secured a place in the health food industry.

In 2023, the company announced that it had acquired a 51% stake in CSPC Jushi Biopharmaceutical Co., Ltd., which would expand its development into the field of innovative biopharmaceuticals. In the same year, it changed its name to CSPC Innovative Pharmaceutical Co., Ltd.

According to publicly available information, Jushi Bio is a subsidiary of CSPC Pharmaceutical Group's macromolecular biopharmaceutical platform. CSPC Innovation's inclusion of Jushi Bio signifies that its fundamentals have shifted from functional raw materials and health foods to innovative drugs.

In December 2025, CSPC Innovation officially submitted its listing application to the Hong Kong Stock Exchange.

The prospectus shows that the company has accumulated strong technical capabilities in the fields of antibody drugs, antibody-drug conjugates (ADCs), and mRNA vaccines, covering disease areas with significant unmet clinical needs and substantial growth potential, such as oncology, autoimmune diseases, and infectious diseases.

Currently, CSPC Innovation has two commercially available biologics : the anti-PD-1 monoclonal antibody Enron Subaitumab (Enshuxing) and the omalizumab biosimilar (Enyitan). In addition, two mRNA vaccines, Duentai and Duentai, have been included in China's emergency use list.

Enron subabazumab received conditional approval from the NMPA in June 2024 for second-line treatment of patients with PD-L1-positive (CPS≥1) recurrent or metastatic cervical cancer.

Although more than ten PD-1 antibodies have been approved in China, their value as cornerstone products of tumor immunotherapy lies in their combination with a wide range of ADC (antibody-drug conjugate) candidates . Currently, CSPC Pharmaceutical Innovation is conducting several clinical studies on the combination of subabamab (enzyme subabamab) and ADC drugs for the treatment of various solid tumors.

Omalizumab (Zhuole) is a classic anti-IgE antibody. Shijiazhuang Pharmaceutical Group's Enyitan is its biosimilar, which has been approved for two major indications: chronic spontaneous urticaria and moderate to severe persistent allergic asthma. In addition, Shijiazhuang Pharmaceutical Group has several other blockbuster drugs in development, including ustekinumab, secukinumab, pertuzumab, and dupilumab, which are expected to generate revenue for the company in the near future.

In terms of drugs under development, CSPC Innovation focuses on ADCs, next-generation ADC-IO combination therapies, and mRNA vaccines , and has built an antibody engineering and ADC platform and an mRNA vaccine development platform.

Among these, ADCs are of paramount importance. Currently, the company has nine ADCs in clinical-stage pipeline, and expects to submit three BLAs to the NMPA between 2026 and 2028: DP303c (HER2 ADC), SYS6010 (EGFR ADC), and SYS6002 (Nectin-4 ADC).

SYS6010 targets EGFR, which is the most common driver gene mutation in lung cancer patients.

Currently, among the EGFR ADC drugs under development globally, only Lepu Medical's vebilocitolumab (MRG003) has been approved in China for the treatment of nasopharyngeal carcinoma, and Rakuten Medical's photoimmunotherapy ADC Akalux has been approved in Japan for the treatment of head and neck malignancies.
For the indication of non-small cell lung cancer (NSCLC), SYS6010 is expected to become the first EGFR ADC drug approved in China.

According to data presented at the AACR 2025 Annual Meeting, SYS6010 has a tolerable safety profile and demonstrates good efficacy in patients with advanced solid tumors, particularly those with EGFR TKI-resistant or EGFR wild-type nsq-NSCLC. In the EGFR-mutant nsq-NSCLC group at a dose of 4.8 mg/kg, the objective response rate (ORR) and disease control rate (DCR) were 46.9% and 93.9%, respectively. In the EGFR wild-type nsq-NSCLC groups at doses of 4.2, 4.8, and 6.4 mg/kg, the ORR and DCR were 71.4% and 85.7%, respectively.

Currently, SYS6010 is in Phase 3 clinical trials and has successively obtained NMPA Breakthrough Therapy designation and FDA Fast Track designation.

SYS6002 is an ADC drug targeting Nectin-4. Currently, there is only one approved Nectin-4 ADC drug globally, namely Padcev from Astellas/Pfizer. Its sales are projected to reach nearly $1 billion in the first half of 2025, a 32% year-on-year increase, and are expected to exceed $2 billion for the full year, making it Pfizer's most relied-upon ADC product. Its commercial breakthrough stems from the success of the ADC+IO combination strategy, propelling its indication from second-line treatment of urothelial carcinoma to first-line standard therapy, replacing the traditional chemotherapy + immunotherapy regimen.

The success of Padcev has made Nectin-4 a popular target for ADC drug development. CSPC Pharmaceutical Group's SYS6002 is among the most advanced drugs globally , with its cervical cancer indication in Phase III clinical trials and its urothelial carcinoma indication in Phase I/II trials.

It is worth mentioning that in February 2023, Giant Biotech entered into an exclusive licensing agreement with Corbus for the development and commercialization of SYS6002 in the United States, the United Kingdom, Canada, Australia, and other countries. Giant Biotech received an upfront payment of US$7.5 million and is entitled to receive up to US$130 million in potential development and regulatory milestone payments and up to US$555 million in potential sales milestone payments.

DP303c is a HER2 ADC that exhibits high affinity for HER2 and can be effectively internalized. Its Phase I clinical trial results showed considerable antitumor activity and acceptable safety in pre-treated patients with HER2-positive advanced solid tumors, particularly HER2-positive breast cancer. Currently, a pivotal Phase III clinical trial of DP303c, compared to T-DM1, is underway in China for HER2-positive breast cancer.

In addition, CSPC Innovation also has potential ADC drug candidates such as SYS6043 (B7-H3 ADC), SYS6023 (HER3 ADC), SYS6040 (DLL3 ADC), SYS6005 (ROR1 ADC), and SYS6041 (FRα ADC).

mRNA vaccines are also a strength of CSPC Pharmaceutical Group. Its Duentai vaccine is the first domestically developed COVID-19 mRNA vaccine.

Among the mRNA vaccines under development, CSPC Pharmaceutical Innovation has targeted shingles and developed SYS6017, which is currently undergoing a Phase 1 clinical trial in China to evaluate its safety and immunogenicity.

03

Conclusion

The projected loss for 2025 is undoubtedly a stressful report card for CSPC Innovation, but it is more like a bill for investing in the future.

The company has heavily invested in innovative biopharmaceuticals, focusing on high-potential areas such as ADCs and mRNA, and has demonstrated its determination to transform itself by deepening its control over core assets through acquisitions. However, whether this high-stakes gamble can lead the company through economic cycles and transform it into a rising star in biotechnology still depends on clinical trials and the development of breakthrough products that truly meet clinical needs.

https://news.yaozh.com/archive/46995.html