Guangzhou Lion TCR's GZL-016 Injection Receives CDE IND Approval: Pioneering mRNA-Encoded TCR-T Therapy for HBV-Related Hepatocellular Carcinoma

On August 21, 2024, according to the CDE official website, Guangzhou Laien Biological Medicine Co., Ltd. (hereinafter referred to as "Laien Bio")IND Application for "GZL-016 Injection" AcceptedAccording to Guangzhou Laien Biological Medicine Co., Ltd., the indication for GZL-016 injection is hepatitis B virus-related hepatocellular carcinoma.Guangzhou Laien Biological Medicine Co., Ltd. owns First-in-Class, the world's first targetingHepatitis B Surface AntigenT-cell receptor-specific T-cell therapy (TCR-T).

GZL-016 Injection is an autologous T-cell therapy that expresses targeting hepatitis B virus surface antigen through mRNA encoding.TCR, granting T cells the ability to specifically recognize and kill hepatitis B virus-related hepatocellular carcinoma. GZL-016 injection effectively utilizes the transient expression characteristics of mRNA, combined with multiple infusion methods, which can not only control safety well but also ensure efficacy. Moreover, patients do not need toClearing, further improving the safety and accessibility of patient medication.

August 2, 2024World's First TCR-T Cell Therapy Afami-cel(Product Name: TECELRA^®）Approved for marketing in the United States, intended for the treatment of advancedSynovial Sarcoma. This significant milestone not only marks the formal transition of the emerging TCR-T treatment technology from the clinical research stage to commercialization but also injects a "boost" into the TCR-T sector, greatly enhancing 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, "predictingAnnual sales peak is expected to reach 400 million US dollars., and Afami-cel also has the potential for expansion into multiple indications. Therefore, we are confident in expecting greater possibilities for its market expansion."

In the past two years, the market heat for TCR therapy has begun to show.January 2022,The World's First TCR Protein Therapy, Kimmtrak, Successfully Receives FDA Approval for Market Launch, indicated for the treatment of 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 cytotoxic function of T cells.

Since its launch, Kimmtrak's market performance has been remarkable.: In the first year of its launch, its global sales reached$141.1 million; In 2023, the net sales for the year climbed to$238.7 million, with a year-on-year increase of up to 69%.

TCR-T therapy has also attracted strong investments from many well-known multinational pharmaceutical companies (MNCs).November 2022,AstraZenecaAnnounced the acquisition of Neogene Therapeutics, a company focused on developing TCR-T therapies, for $320 million. As the company with the first marketed CAR-T product,NovartisInvestments in the TCR-T cell therapy field are also significant. In addition to multiple rounds of investment in TScan, a company focused on 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, in July 2023, an additional $35 million was invested in Immatics, a company in the TCR-T therapy field, demonstrating firm confidence in the promising future of this track.

The TCR-T sector in China has also shown vigorous development recently, attracting a lot of 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, demonstrating the high recognition and support from the NMPA for TCR-T therapy. In August, Northeast Pharmaceutical (SZ000597) announced its plan to acquire 70% of the equity in Beijing Dingcheng Peptide Source, a cell therapy company. This move undoubtedly reflects the strong optimism of established pharmaceutical companies in China toward TCR-T therapy and their active efforts to seize market opportunities while also promoting their own innovative transformation.

About Laien Bio