By Fineline Cube 
Jiangsu Chia Tai Tianqing Pharmaceutical Co., Ltd. (CTTQ), a wholly‑owned subsidiary of Sino Biopharmaceutical Ltd (HKG: 1177), announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted a new drug application (NDA) for its benmelstobart injection + anlotinib hydrochloride capsules combination. The therapeutic target is advanced or unresectable alveolar soft part sarcoma (ASPS), a rare soft‑tissue malignancy with limited approved options.
Why This Matters
- Regulatory Milestone – NMPA acceptance moves the therapy from pre‑clinical to formal review, a critical step toward Chinese market entry.
- Pipeline Expansion – Adds a high‑need indication to Sino Biopharmaceutical’s oncology portfolio, complementing existing approvals for NSCLC and other solid tumours.
- Strategic Synergy – Combines a novel anti‑PD‑L1 antibody with a multi‑targeted tyrosine‑kinase inhibitor, leveraging proven efficacy in multiple cancers.
The Drugs Behind the Application
| Drug | Origin | Mechanism | Current Approvals |
|---|---|---|---|
| Benmelstobart | CTTQ (Sino Biopharm subsidiary) | Humanized anti‑PD‑L1 monoclonal antibody that blocks PD‑L1 binding to PD‑1 & B7.1 on T‑cells, restoring immune activity | Extensive‑stage SCLC, endometrial cancer, renal cell carcinoma |
| Anlotinib | CTTQ | Small‑molecule, multi‑targeted tyrosine‑kinase inhibitor | Advanced NSCLC, soft‑tissue sarcoma, third‑line SCLC, medullary thyroid cancer, differentiated thyroid cancer |
Both agents have a robust safety profile and a track record of synergistic activity, making the ASPS indication a logical next step.
Existing Indications & Ongoing Reviews
- Approved: Extensive‑stage small‑cell lung cancer; endometrial cancer; renal cell carcinoma.
- Under Review: First‑line squamous NSCLC; consolidation therapy for locally advanced/unresectable NSCLC post‑chemoradiotherapy.
Market and Investor Implications
- Revenue Diversification – ASPS represents a niche yet potentially lucrative market; successful approval could unlock new revenue streams.
- Partnership Potential – The Chinese regulatory success may attract global collaborators seeking access to the mainland market, especially given CTTQ’s experience with multi‑indication approvals.
- Shareholder Value – Analysts note that the expanding therapeutic portfolio aligns with Sino Biopharmaceutical’s growth strategy, potentially improving long‑term earnings outlook.-Fineline Info & Tech