Chang Sheng Biotechnology Hits Yearly Revenue High, Advances Cancer Therapy Trials

Regenerative medicine company Chang Sheng Biotechnology announced its July consolidated revenue reached approximately 99.25 million yuan, marking a new annual high. This figure represents a 5.7% increase month-over-month and a 20.7% rise year-over-year. The company's performance reflects strong market demand for regenerative and cell therapies, bolstering its contract development and manufacturing organization (CDMO) services.

Cumulatively, from January to July, Chang Sheng's consolidated revenue totaled 559 million yuan, an increase of about 16% compared to the same period last year. The company attributes this steady growth to the robust demand in the regenerative medicine and cell therapy sectors. The recent implementation of Taiwan's "Regenerative Medicine Law" and "Regenerative Medicine Product Regulations" has further stimulated the industry, leading to a stable increase in collaborative projects with medical institutions and partners. The CDMO business has become a significant and reliable source of revenue and cash flow, supporting operational growth while funding the company's independent new drug research and development.

Chang Sheng is making significant progress with its self-developed allogeneic, off-the-shelf CAR-T cell therapy drug, CAR001. Following the successful completion of Phase 1 dose-escalation trials approved by the U.S. FDA and Taiwan's TFDA, the drug has passed safety monitoring committee review and officially entered the Phase 2a trial stage for efficacy validation. The company has successfully enrolled its first trial participant. Given that glioblastoma multiforme (GBM) is the most common and aggressive primary malignant brain tumor with a poor prognosis, Chang Sheng is actively planning to apply for U.S. FDA Orphan Drug Designation (ODD) for CAR001's GBM indication. Obtaining ODD would provide advantages such as expedited regulatory review, tax benefits, and market exclusivity, enhancing the drug's global competitiveness in clinical development, international licensing, and multi-center trials.

Looking ahead, Chang Sheng Chairman Liu Chu-chi stated that the completion of CAR001's Phase 1 safety validation and its advancement into Phase 2a trials, including the enrollment of the first patient, marks a crucial milestone for the company's independent new drug development. The company plans to continue advancing CAR001's clinical development, international regulatory strategy, and global licensing collaborations. Coupled with its steadily growing CDMO business, Chang Sheng aims to build a dual-engine development strategy of "CDMO + Innovative Cell Therapy."

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CAR001's completion of Phase 1 safety validation and its official entry into Phase 2a trials, along with the enrollment of the first patient, signifies a new important milestone for the company's independent new drug development.