The third quarter of 2025 marked another milestone in China’s ongoing battle against cancer.
The National Medical Products Administration (NMPA) granted approvals to several groundbreaking oncology drugs, giving new hope to patients and advancing China’s reputation as a global force in cancer innovation.
As DengYue Medicine, a healthcare access and patient-support organization that closely tracks regulatory updates, summarized — the progress this quarter highlights how Chinese-developed therapies are not only expanding domestically but also reshaping global oncology standards.
PART 1: Quick Overview
Anticancer Drugs Approved by NMPA in Q3 2025
| No. |
Drug Name |
Brand Name |
Company |
Price |
Approval Status |
Cancer Type |
Target |
Approved Indication |
| 1 |
Tirresilib Tartrate Capsules |
Kaminar® |
Betta Pharmaceuticals |
/ |
NMPA (Jul 2) |
Breast cancer |
CDK4/6 |
In combination with fulvestrant for adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer whose disease has progressed after endocrine therapy |
| 2 |
Suvicitatamab |
Enzeshu® |
Simcere Pharmaceutical Group |
RMB 5,680 per 50 mg vial |
NMPA (Jul 2) |
Ovarian, fallopian tube, or primary peritoneal cancer |
VEGF |
In combination with chemotherapy for adult patients with platinum-resistant recurrent disease who have received no more than one prior systemic therapy |
| 3 |
Lisatoclax Tablets |
Lishtor® |
Ascentage Pharma |
/ |
NMPA (Jul 8) |
CLL/SLL |
Bcl-2 |
For adults with CLL or SLL after at least one prior systemic therapy including a BTK inhibitor |
| 4 |
Lenicabtagene Autoleucel Injection |
Hengkailai® |
Shanghai Hrain Biotechnology |
/ |
NMPA (Jul 30) |
R/R large B-cell lymphoma |
CD19 |
For relapsed/refractory LBCL after two or more lines of systemic therapy |
| 5 |
Datopotamab Deruxtecan for Injection |
Dazhuoyou® / Datroway® |
Daiichi Sankyo & AstraZeneca |
/ |
NMPA (Aug 22) |
Breast cancer |
TROP-2 |
For unresectable or metastatic HR-positive, HER2-negative breast cancer after endocrine therapy and at least one chemotherapy |
| 6 |
Dilorac |
Xuanfenin® |
Xuanzhu Biopharma (co-developed with Simcere) |
/ |
NMPA (Aug 22) |
NSCLC |
ALK |
For ALK-positive NSCLC patients untreated with ALK inhibitors |
| 7 |
Zemetostat Tablets |
Arigen® |
Jiangsu Hengrui Pharmaceuticals |
RMB 7,467.6 per 50 mg |
NMPA (Aug 29) |
PTCL (R/R) |
EZH2 |
For relapsed or refractory PTCL after at least one prior therapy |
| 8 |
Zongaitinib Tablets |
Sentetu® |
Boehringer Ingelheim |
/ |
NMPA (Aug 29) |
NSCLC |
HER2 |
For HER2-mutated advanced or metastatic NSCLC after prior therapy |
| 9 |
Encorafenib + Cetuximab |
Bitawei® + Erbitux® |
Pierre Fabre & Eli Lilly |
/ |
NMPA (Jul 25) |
CRC |
BRAF V600E |
For BRAF V600E-mutant mCRC after prior systemic treatment |
| 10 |
Amivantamab + Lazertinib |
Ryke® + Leke® |
Johnson & Johnson |
Amivantamab 350 mg: RMB 5,104.2 per vial |
NMPA (Jul 30) |
NSCLC |
EGFR/MET |
First-line therapy for EGFR-mutant locally advanced or metastatic NSCLC |
PART 2: Detailed Drug Review
1. Tirresilib Tartrate Capsules (Kaminar®)
Date: July 2, 2025
Company: Betta Pharmaceuticals
Mechanism: CDK4/6 inhibitor halting cancer cell division. When combined with fulvestrant, it demonstrates synergy and benefits even resistant patients.
According to DengYue Medicine’s analysis, the approval of Kaminar® adds another homegrown CDK4/6 inhibitor to China’s arsenal, enhancing accessibility for breast cancer patients nationwide.
2. Suvicitatamab (Enzeshu®)
Company: Simcere Pharmaceutical Group
Mechanism: VEGF inhibitor reducing tumor angiogenesis.
Highlights: Phase III trial showed OS and PFS benefits with manageable toxicity.
DengYue Medicine notes that anti-VEGF therapies remain a mainstay in ovarian cancer care, and local development could lower the cost burden for patients in China.
3. Lisatoclax Tablets (Lishtor®)
Company: Ascentage Pharma
Mechanism: Bcl-2 inhibitor restoring apoptosis.
Highlights: Effective in BTK inhibitor-failed patients, with step-up dosing improving adherence.
4. Lenicabtagene Autoleucel Injection (Hengkailai®)
Company: Shanghai Hrain Biotechnology
Mechanism: CD19-directed CAR-T cell therapy.
Highlights: ORR 74.1%, CRR 49.4%, low-grade CRS and no ICANS observed.
DengYue Medicine observes that domestic CAR-T therapies are becoming more clinically practical, signaling China’s readiness to compete with global cell therapy leaders.
5. Datopotamab Deruxtecan (Dazhuoyou® / Datroway®)
Companies: Daiichi Sankyo & AstraZeneca
Mechanism: TROP2-directed ADC carrying a DXd payload.
Highlights: Improved PFS and ORR versus chemotherapy; favorable Chinese subgroup data.
6. Dilorac (Xuanfenin®)
Companies: Xuanzhu Biopharma & Simcere
Mechanism: ALK inhibitor with superior intracranial control.
Highlights: ORR 86.9%; 92.3% brain metastasis response rate.
7. Zemetostat Tablets (Arigen®)
Company: Hengrui Pharma
Mechanism: EZH2 inhibition reversing abnormal epigenetic regulation.
Highlights: ORR 64.2%, CR 32.8%, median DoR 18.7 months.
8. Zongaitinib Tablets (Sentetu®)
Company: Boehringer Ingelheim
Mechanism: HER2 exon 20-selective inhibitor.
Highlights: ORR 71%, PFS 12.4 months, intracranial benefit observed.
9. Encorafenib + Cetuximab (Bitawei® + Erbitux®)
Mechanism: Dual blockade of the BRAF V600E-driven MAPK pathway, suppressing tumor growth in mCRC.
10. Amivantamab + Lazertinib (Ryke® + Leke®)
Mechanism: Dual inhibition of EGFR and MET; strong synergy demonstrated in MARIPOSA trial.
Highlights: PFS 23.7 vs 16.6 months; significant OS and intracranial benefit.
The approval of these ten oncology drugs underscores how China’s innovation ecosystem is maturing—shifting from “follow-up” to “breakthrough.”
From targeted inhibitors and ADCs to next-generation CAR-T and dual immunotherapy combinations, 2025 Q3 represents a pivotal chapter in China’s cancer treatment evolution.
DengYue Medicine emphasizes that as more of these therapies become accessible to patients in Greater China and beyond, the impact will extend far beyond statistics—it will translate into extended lives and renewed hope for cancer families worldwide.
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