Zelgen Biopharma Submits BLA for Innovative rhTSH Product

On June 5, 2024, Zelgen Biopharmaceuticals made a noteworthy stride in the pharmaceutical industry by submitting a Biologics License Application (BLA) to the National Medical Products Administration (NMPA) for its innovative injectable recombinant human thyroid-stimulating hormone (rhTSH). The application now awaits formal review acceptance.

The primary focus of this application is the use of rhTSH in radioactive iodine (131I) whole-body scanning (WBS) and serum thyroglobulin (Tg) testing. These are critical follow-up procedures for patients with differentiated thyroid cancer who have undergone thyroidectomy. This marks a significant development in the Chinese market where, up until now, no recombinant human thyroid-stimulating hormone has been approved for this application.

The market has responded positively to this announcement, with Zelgen Biopharmaceuticals's stock price experiencing a significant rise, increasing by over 60% from its February low. This milestone is Zelgen's fourth product to reach the New Drug Application (NDA) phase, highlighting the company's robust pipeline and its ability to innovate.

Thyroid cancer cases are increasing globally, and the unique benefits of thyroid-stimulating hormone in managing this cancer type present a lucrative market opportunity. At present, Sanofi's Thyrogen is the only recombinant human TSH approved in the United States. However, the original Thyrogen has encountered manufacturing hurdles in obtaining approval in mainland China.

In the Chinese market, Zelgen Biopharmaceuticals's rhTSH and Suntory Biotech's SNA001, which was approved in April 2024, are the two primary domestic players. Each company has strategically chosen different initial indications to mitigate competitive risks. SNA001 is geared towards thyroid cancer treatment, while Zelgen's rhTSH is aimed at post-surgical diagnostic use. This strategic differentiation helps both companies reduce direct competition in this emerging market.

The submission of the BLA comes on the heels of positive results from Zelgen's Phase III ZGTSH004 trial. This positions Zelgen Biopharmaceuticals favorably to meet the growing demand for innovative thyroid cancer management solutions in China. The company's strong pipeline and impressive stock performance indicate that further exciting developments are anticipated in the industry, promising significant returns for investors.