Tasly Pharmaceutical Group Co., Ltd. (SHA: 600535) announced that it has received the “Clinical Trial Approval Notification” issued by China’s National Medical Products Administration (NMPA) for TDX105 Granules, a Category 1.1 traditional Chinese medicine (TCM) innovative drug, authorizing the company to conduct Phase II and Phase III clinical trials for the treatment of chemotherapy/targeted therapy‑induced skin adverse reactions (hand‑foot skin reaction, hand‑foot syndrome) of the damp‑heat with blood stasis pattern.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | National Medical Products Administration (NMPA), China |
| Company | Tasly Pharmaceutical Group Co., Ltd. (SHA: 600535) |
| Product | TDX105 Granules (granule dosage form) |
| Classification | TCM innovative drug, Category 1.1 |
| Acceptance No. / Notification No. | CXZL2600066 / 2026LP03094 |
| Application Accepted | 27 July 2026 |
| Approved Scope | Phase II & III trials for tumor chemotherapy/targeted therapy‑related skin adverse reactions (hand‑foot skin reaction, hand‑foot syndrome), damp‑heat with blood stasis pattern |
| Cumulative R&D Investment | RMB 12.6267 million (as of announcement date) |
Drug Profile & Development Background
- Origin: TDX105 Granules are developed from a clinical experience formula of the Cancer Hospital, Chinese Academy of Medical Sciences (National Cancer Center).
- Formulation Consistency: The prescription composition and dosage remain fully consistent with the clinical experience formula as used in practice.
- Clinical Track Record: The underlying formula has been in clinical use for many years; clinical observation indicates marked relief of itching, pain and other skin lesions caused by anticancer drug‑related skin adverse reactions, with favorable efficacy and safety.
- Proposed Functions & Indications: Clearing heat and drying dampness, activating blood circulation and resolving stasis – indicated for damp‑heat with blood stasis pattern in chemotherapy/targeted therapy‑related skin adverse reactions, manifesting as bright red or dark red plaques and papules, blisters, skin erosion with exudation, epidermal exfoliation, or surrounding bruising and dull discoloration.
Disease Background & Unmet Need
- Hand‑foot skin reaction (HFSR) and hand‑foot syndrome (HFS) are common, dose‑limiting toxicities of many cytotoxic chemotherapies and targeted agents (e.g., fluoropyrimidines, multikinase inhibitors), causing painful erythema, blistering and desquamation that can force dose reduction or discontinuation of anticancer therapy.
- Current management is largely supportive – topical emollients, keratolytics and dose modification – with limited disease‑specific options, leaving substantial unmet need for effective adjunctive therapy.
- A TCM innovative drug with years of real‑world clinical experience offers a differentiated supportive‑care approach that may help patients stay on optimal anticancer treatment.
Market Impact & Outlook
- Pipeline Expansion: The approval adds an oncology supportive‑care asset to Tasly’s TCM innovative drug pipeline, extending its franchise beyond cardiovascular TCM products.
- De‑risked Development: Consistency with a long‑used clinical experience formula and accumulated safety observations provide a favorable starting point for Phase II/III execution.
- Target Population: Given the high incidence of HFSR/HFS among the large chemotherapy‑ and targeted‑therapy‑treated cancer population in China, the indication addresses a broad supportive‑care market.
- Trial Details: Study design, sites, patient numbers and timelines were not disclosed.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding the clinical development, regulatory review and commercialization prospects of TDX105 Granules. Actual results may differ materially due to risks including clinical trial outcomes, safety findings, subsequent NMPA review decisions, and competitive dynamics in the supportive‑care market.-Fineline Info & Tech
