What is China's new anti-cancer drug?

In the hematology ward of Shanghai Ruijin Hospital, 68-year-old Ms. Li held the CAR-T therapy consent form she had just received, her eyes slightly reddened. Three months earlier, she had been diagnosed with refractory diffuse large B-cell lymphoma. Traditional chemotherapy caused her white blood cell count to plummet and severe hair loss. Even more devastating was the reality that the targeted drugs and immunotherapies available domestically at the time either had limited efficacy or were prohibitively expensive. That changed when her doctor told her, “We now have a domestically produced CAR-T product. Clinical trial data show a response rate exceeding 80% in some patients.”

This scene is playing out in examination rooms and hospital wards across China, affecting millions of families battling cancer. Over the past decade, China's cancer drug R&D landscape has undergone a seismic shift: from passively “waiting for imported drugs to become cheaper” to proactively “developing new drugs independently”; from following by “imitating international targets” to leading with “breakthroughs in original mechanisms.” For cancer patients worldwide, China's novel anti-cancer drugs are no longer a foreign concept but are increasingly becoming a key variable reshaping the treatment landscape.

I. Behind the “China Speed”: The Transformation from “Generic Drug Giant” to “Innovative Drug Powerhouse”

Around 2010, China's cancer treatment remained heavily reliant on imported drugs—a newly approved anti-cancer drug globally would typically take 3-5 years to enter the Chinese market. Even upon launch, exorbitant prices often left ordinary families “terrified at the mention of medication.” The turning point came in 2015: China launched reforms to its drug review and approval system, introducing mechanisms like “priority review” and “conditional approval,” compressing the new drug market entry cycle from an average of 8-10 years to 3-5 years. Since 2016, the National Major Science and Technology Special Project for Innovation of Major New Drugs has intensified support, investing over 10 billion yuan cumulatively to advance innovation in oncology and rare diseases. Following the normalization of medical insurance negotiations in 2018, multiple domestically produced anticancer drugs rapidly entered the insurance reimbursement list through “price-volume negotiations,” reducing patient out-of-pocket costs from tens of thousands to thousands of yuan.

Alongside these policy dividends, capital influx and scientific research accumulation have formed a “dual-engine drive.” From 2020 to present, over 60% of innovative Chinese pharmaceutical companies listed on Hong Kong's 18A and STAR Market platforms have focused on oncology. In top-tier journals like Nature Medicine and Cancer Cell, Chinese researchers' contributions to papers on tumor immunotherapy and targeted treatments have surged from under 5% in 2015 to 18% in 2024.

These shifts ultimately translate into “China-developed drugs” within patients' reach. Take PD-1/PD-L1 inhibitors as an example: China's first PD-1 drug (Camrelizumab) completed the entire process from clinical trials to market approval in just four years, with its efficacy for liver cancer even surpassing some imported drugs. In 2023, another domestically developed PD-1 inhibitor (toripalimab) received FDA Breakthrough Therapy designation, becoming the first Chinese-developed anti-cancer drug to earn this distinction.

II. Technological Breakthroughs: Global Competitiveness from “Target-Following” to “Mechanism-Creating”

Whereas a decade ago China's anti-cancer drugs were still “chasing internationally popular targets” (such as EGFR and ALK inhibitors), today's Chinese scientists are exploring “original targets” and “disruptive technologies.”

• Antibody-Drug Conjugates (ADCs): Dubbed “biological missiles,” these drugs use antibodies to precisely target tumor cells before releasing high-concentration chemotherapy drugs. Rongchang Biopharma's independently developed vedicitinumab (RC48) became the world's first domestically produced ADC approved for urothelial carcinoma, overcoming traditional limitations by demonstrating efficacy in patients with low HER2 expression. In 2024, another domestically developed ADC drug (SHR-A1811) demonstrated “superior killing power” against HER2-mutated tumors in breast cancer clinical trials. Its data was selected by the American Society of Clinical Oncology (ASCO) as a Breakthrough of the Year.

• Bispecific Antibodies: These activate a “dual attack” by simultaneously binding to tumor cells and immune cells. CanSino Biologics' cadunimab (PD-1/CTLA-4 bispecific antibody) became the world's first approved bispecific anti-tumor drug, nearly doubling efficacy over traditional PD-1 monotherapy in advanced cervical cancer. In 2024, its Phase III trial for gastric cancer indications succeeded, positioning it to become the world's first bispecific drug with multi-tumor indications.

• Cell and Gene Therapy (CGT): Taking CAR-T therapy as an example, Chinese pharmaceutical companies' rapid expansion in this field has astonished the global community. In 2021, Fosun Kite's Axicabtagene Ciloleucel became China's first approved CAR-T product; In 2023, WuXi AppTec's Riximab injection (for large B-cell lymphoma) achieved a 92% response rate with superior safety. More notably, Chinese scientists are exploring “universal CAR-T” (UCAR-T) therapies that eliminate individual variability through gene editing. This approach holds promise for future off-the-shelf availability, significantly reducing treatment costs.

III. Global Sharing: How China's Innovative Drugs Are Redrawing the World's “Cancer Treatment Map”

The impact of China's novel anti-cancer drugs has long transcended national borders.

In Southeast Asia, Chinese-produced PD-1 inhibitors have entered markets like Thailand and Indonesia through overseas collaborations, offering lower-cost access to treatments that align with international standards for patients with liver cancer and nasopharyngeal carcinoma. In the Middle East, multicenter clinical trials of Chinese ADC drugs have enrolled patients from Saudi Arabia and the UAE, with efficacy data for HER2-positive breast cancer incorporated into local treatment guidelines. In Africa, Chinese companies collaborate with local health authorities, employing a “generic drugs + innovative drugs” strategy to extend survival for advanced lung cancer patients from 6 months to over 12 months.

More significantly, China is emerging as a global “collaborative hub” for cancer research. In 2024, Peking University Cancer Hospital launched the “Global Multicenter Trial of Chinese-Developed KRAS G12C Inhibitors” in partnership with MD Anderson Cancer Center—the first China-led study targeting KRAS (once deemed an “undruggable” mutation) spanning Europe, America, and Asia. As The New England Journal of Medicine commented: “China is no longer a bystander in global cancer R&D, but one of the rule-makers.”

IV. From “Life-Saving Drugs” to “Right to Health”: A Warmer Future

Returning to Ms. Li from the beginning, three months after receiving China-developed CAR-T therapy, her tumor markers dropped from abnormally high levels to within normal ranges. At her follow-up appointment, she walked into the clinic unaided. She remarked, “I used to think ‘innovative drugs’ were unattainable luxuries. Now I realize they are lifelines ordinary people can grasp.”

This captures the most profound significance of China's new anti-cancer drugs: They are not merely molecular structures in laboratories or data curves from clinical trials. They represent hope reignited for countless families, embody the “people-centered” approach under the Healthy China strategy, and contribute “Eastern wisdom” to humanity's enduring battle against cancer.

When cancer patients worldwide begin saying, “Let's try China's new drugs,” we know—in this race for life, China has accelerated at its own pace.

Document dated 2025-10-29 10:22 Modify