Changsheng’s revenue in September hit a new high this year, reaching 110 million yuan, an annual increase of more than 21%

Changsheng’s revenue in September hit a new high this year. On the right is Changsheng Chairman Liu Zhuqi, and on the left is General Manager Huang Wenliang. (Provided by Changsheng)

[Reporter Chen Yongji/Taipei Report] Regenerative medicine company Changsheng International Biotech (6712) announced today (1) that its September consolidated revenue was approximately 110 million yuan, setting a new monthly high this year, with a monthly increase of 0.75% and an annual increase of more than 21%. The cumulative consolidated revenue in the first nine months of this year reached 779 million yuan, continuing to show double-digit growth, with an annual increase of 17.6%.

Changsheng said that with the support of stable revenue, the company's independently developed allogeneic, off-the-shelf CAR-T cell therapy new drug CAR001 has officially obtained Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA). The applicable disease range covers a wide range of "malignant gliomas", adding key momentum to its global commercialization and international licensing layout.

Changsheng said that its revenue has maintained steady growth in the first three quarters of this year, mainly due to the steady advancement of cell storage, cell preparation services and CDMO (commissioned development and manufacturing services) related businesses. Changsheng has injected cash flow through stable CDMO and cell services to support independent new drug research and development, and has successfully established a dual-engine development model with "CDMO + innovative cell therapy".

Changsheng pointed out that the Phase IIa clinical trial of CAR001 is currently being accelerated, focusing on the treatment of advanced or relapsed and refractory solid tumors including glioblastoma multiforme, colorectal cancer, triple-negative breast cancer and non-small cell lung cancer, and is expected to include 27 subjects. Obtaining the U.S. ODD qualification this time will be closely connected with the accumulation of clinical data and publication in international journals.

Looking forward to the future, Changsheng will continue to implement the dual-track strategy of "CDMO + innovative cell therapy" and accelerate the global commercialization process of CAR001 and other independent new drug pipelines under a healthy cycle that balances profit and research and development.