CSPC Innovation Pharmaceutical Co Ltd Class A

CSPC Innovation Pharmaceutical Co., Ltd. announced on September 14, 2026 that its controlling subsidiary CSPC Megalith Biopharmaceutical Co., Ltd. presented Phase I/II clinical study data for SYS6010 combined with enlonstobart injection in an oral presentation at the 2026 World Conference on Lung Cancer. The study was led by Professor Zhou Caicun of Shanghai East Hospital, evaluating the safety, tolerability, and preliminary efficacy of SYS6010, an EGFR-targeting ADC, combined with enlonstobart, a PD-1 inhibitor, with or without chemotherapy in patients with EGFR and ALK wild-type advanced non-small cell lung cancer and other conditions. As of July 13, 2026, a total of 123 patients with untreated driver-gene-negative advanced non-small cell lung cancer were enrolled across two dosing regimens, with a median follow-up of 10.8 months. In terms of safety, the incidence of grade 3 or higher treatment-related adverse events was 51.6% and 52.5% for the two regimens, respectively, and the incidence of adverse events leading to discontinuation was 9.7% and 8.2%, respectively. In terms of efficacy, the confirmed objective response rates in the overall population were 58.9% and 49.2%, respectively, and the ORRs in patients with high PD-L1 expression were 77.8% and 82.4%, respectively. Among patients with high PD-L1 expression and non-squamous histology, the ORRs reached 81.8% and 91.7%, respectively. The combination therapy has now entered Phase III clinical trials, and the company cautioned that innovative drug development involves high investment, high risk, and long cycles, and will not have a significant impact on performance in the short term.

CSPC Innovation Pharmaceutical Co., Ltd. announced that SYS6010, developed by its controlling subsidiary CSPC Megalith Biopharmaceutical Co., Ltd., has been included in the breakthrough therapy designation list by the Center for Drug Evaluation of the National Medical Products Administration. The proposed indication is for patients with recurrent or metastatic head and neck squamous cell carcinoma who have failed immunotherapy and platinum-based chemotherapy. SYS6010 is an antibody-drug conjugate targeting EGFR, composed of a humanized anti-EGFR monoclonal antibody linked to a topoisomerase I inhibitor payload via a cleavable linker. According to GLOBOCAN 2024 estimates, head and neck squamous cell carcinoma accounts for approximately 845,000 new cases and 392,000 deaths globally each year, with a five-year overall survival rate of only 40 to 50 percent. A pivotal Phase III clinical trial of SYS6010 monotherapy for this indication is currently underway. The drug has previously received two breakthrough therapy designations, for EGFR-mutant non-small cell lung cancer and esophageal squamous cell carcinoma. After inclusion in the breakthrough therapy designation list, the Center for Drug Evaluation will prioritize resources and strengthen guidance. However, the company cautioned that drug development involves high investment, high risk, and long cycles, and will not have a significant impact on short-term performance.

CSPC Innovation released its 2026 interim report, with net profit attributable to the parent company of 1.261 billion yuan, an increase of 1.264 billion yuan compared with the same period last year, turning losses into profits. The company's total operating revenue was 3.24 billion yuan, up 208.72 percent year on year, and net cash inflow from operating activities was 2.776 billion yuan. The latest gross margin was 76.74 percent, ROE was 32.04 percent, and diluted earnings per share was 0.91 yuan.

On the evening of the 17th, multiple A-share companies disclosed their 2026 half-year reports, with first-half net profits rising sharply year on year. Sunwave Communications achieved net profit attributable to owners of the parent company of 50.3935 million yuan, up 1,825.74 percent year on year; Youngy Company posted net profit of 1.002 billion yuan, up 1,076.14 percent; Do-Fluoride New Materials reported net profit of 512 million yuan, up 897.19 percent. In addition, companies including Grand Industrial Holding, Hebang Biotechnology, Chengxing Group, Shanghai Ailu Package, Zhaojin Gold, Fudan Microelectronics, Raytron Technology, and Decole saw year-on-year net profit growth of more than 100 percent, among which 10 stocks including Shenzhen Keda achieved net profit growth of over 100 percent year on year. CSPC Innovation Pharmaceutical, Tianhua New Energy, Minmetals New Energy, and Zhangjiajie Tourism turned losses into profits year on year.

CSPC Innovative Pharmaceutical's controlled subsidiary CSPC Megalith Biopharmaceutical, in collaboration with the Institute of Microbiology of the Chinese Academy of Sciences, has developed the monkeypox mRNA vaccine SYS6037 injection. Its clinical trial application has been approved by the US FDA, allowing clinical research for monkeypox prevention to proceed, with IND number 33047. The vaccine encodes multiple antigens from a single mRNA strand, featuring a streamlined technical approach. Preclinical studies show its immunogenicity and protective efficacy are superior to the live attenuated vaccine Tian Tan strain, and it demonstrates broad cross-reactivity against various orthopoxviruses. The company cautions that the drug still needs to complete clinical trials and receive FDA approval before it can be marketed. Research and development involves high investment, high risk, and long cycles, and will not have a significant impact on performance in the short term.

Shi Yao Innovation Pharmaceutical Co., Ltd.'s subsidiary, Shi Yao Group Jushi Biopharmaceutical Co., Ltd., has initiated a Phase Ib/II clinical trial of SYS6090 injection in combination therapy for advanced or metastatic colorectal cancer. SYS6090 injection is a recombinant fully human anti-PD-1 fusion protein fused with IL-15. Preclinical studies have shown it significantly inhibits tumor growth with good safety and tolerability. The company received clinical trial approval in March 2026 and has now begun patient recruitment. The company cautions that the drug still needs to pass regulatory review before it can be marketed and will not have a significant impact on performance in the short term.

CSPC Innovation Pharmaceutical's holding subsidiary, CSPC Megalith Biopharmaceutical, has initiated a Phase II clinical trial of SYS6041 in combination therapy for recurrent ovarian cancer. The trial is an open-label, multi-cohort, multi-center design, approved by the National Medical Products Administration in June 2026, aiming to evaluate the safety, tolerability, and anti-tumor efficacy of different combination regimens. Subject recruitment and screening are currently progressing actively. SYS6041 is an antibody-drug conjugate targeting folate receptor alpha, which can specifically bind to and kill tumor cells while exerting a bystander effect. The company cautions that drug development involves high investment, high risk, and long cycles, and will not have a significant impact on performance in the short term.

Shenhuo Shares and Xinyaqiang disclosed their 2026 semi-annual reports on the evening of July 27, while Yishitong and CSPC Innovation released semi-annual earnings forecasts. All four companies showed overall improvement in first-half operating performance. Shenhuo Shares achieved operating revenue of 24.791 billion yuan, up 21.35 percent year-on-year, with net profit attributable to shareholders of 4.781 billion yuan, up 151.06 percent, mainly driven by higher selling prices for coal and electrolytic aluminum and lower alumina prices. Xinyaqiang posted operating revenue of 409 million yuan, up 27.3 percent, and net profit attributable to shareholders of 72.2408 million yuan, up 22.42 percent, as improved supply and demand in the organosilicon industry pushed core product sales to a record high. Yishitong expects operating revenue between 400 million and 420 million yuan, up 47.33 to 54.69 percent, and net profit attributable to shareholders between 9.5 million and 14 million yuan, turning from a loss to a profit year-on-year, benefiting from increased sales of lithium battery coating materials driven by the new energy vehicle and energy storage markets. CSPC Innovation expects net profit attributable to shareholders between 1.18 billion and 1.36 billion yuan, turning from a loss to a profit, as R&D achievements in its biopharmaceutical business continue to materialize.

The marketing application for envafolimab trastuzumab injection, a HER2 ADC, submitted by a controlled subsidiary of CSPC Innovation, has been accepted. The drug is intended for second-line and later treatment of HER2-positive breast cancer.

CSPC Innovation Pharmaceutical's holding subsidiary, CSPC Megalith Biopharmaceutical, has initiated a Phase III clinical trial for SYS6043. The trial is a randomized, multicenter, open-label study designed to evaluate SYS6043 versus investigator's choice of chemotherapy in participants with platinum-resistant advanced ovarian cancer, primary peritoneal cancer, and fallopian tube cancer. SYS6043 is a B7-H3-targeting antibody-drug conjugate. Its antibody component can specifically bind to and internalize into tumor cells, where it is cleaved by proteases to release a small-molecule toxin that kills tumor cells and exerts a bystander effect. Meanwhile, Fc engineering reduces lymphocyte uptake to lower the risk of off-target toxicity. Megalith Biopharmaceutical received the Phase III clinical trial approval notice from the National Medical Products Administration in July 2026, and subject recruitment and screening are now actively underway. The company also cautioned that drug development involves high investment, high risk, and long cycles, and products can only be marketed after review by the National Medical Products Administration, with no significant short-term impact on financial performance.