Lion TCR's mRNA-Encoded TCR-T Therapy GZL-016 Granted IND Approval in China for HBV-Related Hepatocellular Carcinoma

Nov 14, 2024 08:26 CST Updated 08:26

Lion TCR

Developer of Novel Immunotherapies

On November 12, 2024, according to the official website of the Center for Drug Evaluation under the National Medical Products Administration, the mRNA TCR-T therapy "GZL-016 Injection" developed by Guangzhou Laien Biological Medicine Co., Ltd. (hereinafter referred to as "Laien Bio") was approved by the CDE to conduct clinical trials for the treatment of hepatitis B virus-related hepatocellular carcinoma.This product is a First-in-Class, globally pioneering T-cell therapy (TCR-T) targeting the hepatitis B virus surface antigen with a specific T-cell receptor.

GZL-016 Injection is an autologous T-cell therapy that uses mRNA to encode and express TCR targeting the hepatitis B virus surface antigen, enabling T cells to specifically recognize and kill hepatitis B virus-related hepatocellular carcinoma. By effectively utilizing the transient expression characteristics of mRNA and combining multiple infusions, GZL-016 Injection can both control safety well and ensure efficacy. Moreover, patients do not need lymphodepletion before treatment, further enhancing the safety and accessibility of the medication.

On August 2, 2024, the world's first TCR-T cell therapy, Afami-cel (brand name: TECELRA®), was approved for marketing in the United States for the treatment of advanced synovial sarcoma. This significant milestone not only marks the formal transition of the emerging TCR-T therapeutic technology from the clinical research stage to commercialization but also injects a "booster" into the TCR-T sector, greatly boosting the confidence of TCR-T innovative pharmaceutical companies and driving the热度 of the TCR-T赛道 to rise once again.

Adaptimmune, the developer of Afami-cel, expressed optimism about the market prospects, stating, "Annual peak sales are expected to reach $400 million. Additionally, Afami-cel has the potential for expansion into multiple indications. Therefore, we are confident in anticipating broader market opportunities."

In the past two years, the market heat for TCR therapy has started to show. In January 2022, Kimmtrak, the world's first TCR protein therapy, was successfully approved by the FDA for marketing, used to treat adult patients with HLA-A*02:01-positive unresectable or metastatic uveal melanoma. Kimmtrak is a TCR/CD3 bispecific fusion protein that effectively connects tumor cells with T cells, thereby activating the killing function of T cells.

Since its launch, Kimmtrak has achieved remarkable market performance: in its first year on the market, its global sales reached $141.1 million; in 2023, the full-year net sales climbed to $238.7 million, representing a year-over-year increase of 69%.

TCR-T Therapy Also Attracts Strong Layouts from Numerous Well-Known Multinational Pharmaceutical Companies (MNCs). In November 2022, AstraZeneca announced a $320 million acquisition of Neogene Therapeutics, a company focused on developing TCR-T therapy. As the company with the first marketed CAR-T product, Novartis' investment in the TCR-T cell therapy field is also significant. In addition to multiple rounds of investment in TScan, a company specializing in TCR-T therapy, Novartis has also reached a collaboration worth hundreds of millions of dollars with TScan to jointly develop TCR-T cell therapies targeting multiple new antigens. Bristol-Myers Squibb (BMS) also made an additional $35 million investment in July 2023 into Immatics, a company in the TCR-T therapy field, demonstrating firm confidence in the future prospects of this track.

China's TCR-T sector has also recently demonstrated vigorous development, attracting significant attention and investment. In July 2024, the TCR-T therapy (TAEST16001 injection) under research by Xiangxue Life Sciences was included in the list of breakthrough therapies by the National Medical Products Administration, indicating strong recognition and support from the administration for TCR-T therapy. In August, Northeast Pharmaceutical announced its intention to acquire 70% of the equity in cellular therapy company Beijing Dingcheng Taiyuan, a move that undoubtedly reflects the strong confidence of China’s established pharmaceutical enterprises in TCR-T therapy. These companies are actively positioning themselves to seize market opportunities while also driving their own innovative transformation.

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Disclaimer: The content is sourced from the company's official channels, the CDE website, etc. This article aims to share knowledge, and all content is for reference only and does not constitute any advice.