Highlights from the Announcement

• Drug Approval Details: The new product, Loxoprofen Sodium Cataplasms, is a gel-type patch indicated for the relief of inflammation and pain associated with osteoarthritis, muscle pain, and post-traumatic swelling and pain.
• Registration Classification: Approved as a Category 4 chemical drug, the product has passed the quality and efficacy consistency evaluation with the reference-listed drug, ensuring parity with leading market standards.
• Manufacturer and Authorisation: The marketing authorisation holder is Xinxin Pharmaceutical Plant, while the manufacturer is Beijing Baiao Pharmaceutical Co., Ltd.
• Regulatory Validity: The approval is valid until 17 November 2030, under the certificate number 2025S03428 and approval number H20255958.
• Compliance Requirements: Production and sales are contingent on meeting Good Manufacturing Practice (GMP) requirements.

Financial and Strategic Implications

• R&D Investment: The Company has invested approximately RMB 37.88 million in the development of this product, positioning it as a strategic entry point into the transdermal drug delivery market.
• Market Position: Originally developed by LEAD CHEMICAL CO., LTD., Loxoprofen Sodium Cataplasms is already among the top-selling analgesics in China. In 2024, total nationwide sales exceeded RMB 1,700 million, with the first half of 2025 registering sales of over RMB 980 million—demonstrating robust double-digit annual growth.
• Technology Platform: The development of this drug has enabled the Company to establish a modern Chinese medicine cataplasm technology platform, integrating advanced drug delivery technology with traditional Chinese medicine principles.
• Product Expansion: The Company plans to leverage this platform to expand its product portfolio across chemical drugs, traditional Chinese medicines, and wellness patches, aiming to offer patients a broader range of therapeutic options and improve the overall medication experience.

Shareholder Considerations and Price-Sensitive Information

• Short-term Financial Impact: The announcement states that the approval is not expected to have a material impact on the Company’s short-term financial performance. However, the entry into a high-growth market segment and the establishment of a new technology platform could have longer-term strategic benefits.
• Market Risks: There are uncertainties regarding the transition from marketing approval to actual production and sales, including potential fluctuations due to national policies and market conditions.
• Trading Caution: Investors are advised to exercise caution when trading shares of the Company during the period of commercialisation roll-out, as unforeseen regulatory or market issues could affect the scale and timing of future revenues.

Conclusion

The approval of Loxoprofen Sodium Cataplasms represents a strategic milestone for Tianjin Pharmaceutical Da Ren Tang Group, marking its entry into the modern gel-type cataplasm market and strengthening its position in transdermal drug delivery. While immediate financial impacts may be limited, the long-term prospects for growth and market expansion are significant, especially given the product’s strong market track record and the Company’s new technology platform. Investors should monitor further developments related to production, sales, and portfolio expansion, as these could have a material impact on the Company’s value proposition.

Disclaimer: This article is prepared for informational purposes only and does not constitute investment advice. All information is based on publicly disclosed company documents and is subject to change without notice. Investors should conduct their own due diligence and consult professional advisors before making investment decisions.

View TJ DaRenTang USD Historical chart here