Hengrunda Sheng's CD19-Targeted CAR-T Therapy Renikio Oran赛 Injection (HR001) Approved as China's Fourth Domestic Product; Company Files IPO Prospectus

On July 30, the NMPA website announced that Shanghai Hengrun Dasheng Biotechnology Co., Ltd's "Ranikiolucel Injection" (HR001) has been approved for marketing in China.For the treatment of adult relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma not otherwise specified, diffuse large B-cell lymphoma transformed from follicular lymphoma, high-grade B-cell lymphoma with MYC and BCL2 rearrangements, and high-grade B-cell lymphoma not otherwise specified.Notably, this is the company's first commercially launched CAR-T cell therapy.

Screenshot source: NMPA official website

Rani Kioles is a CD19-targeted CAR-T therapy. According to the prospectus, its relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia (B-ALL) indication is expected to enter in 2025.Phase II ClinicalR&D.

Previously, the Phase II clinical trial HRAIN01-NHL01-II of this therapy for r/r NHL was published at the 2024 AACR. This is an open-label, single-arm, multicenter clinical study conducted in China, enrolling patients who have undergone at least two lines of treatment (must include anthracyclines and CD20-targeted drugs) or autologous hematopoietic stem cell transplantation.

As of May 16, 2023, a total of 81 patients had received infusions. The baseline ECOG score of the patients was 0~1, 51.9% were male, the median age was 53.4 years (range: 23~74 years), 3.7% were CD19-negative, and 91.4% had diffuse large B-cell lymphoma (DLBCL).

In terms of efficacy,

• The median follow-up was 160 days (range 7-454 days),3 Months, 6 Months, and Best Objective Response Rate（ORR）53.1%, respectively（95% CI: 41.7~64.3）、45.7%（95% CI: 34.6~57.1）And 74.1%（95% CI: 63.1~83.2）；

• 3-month, 6-month, and Best Complete Remission Rate（CRR）32.1%, respectively（95% CI: 22.2~43.4）、29.6%（95% CI: 20.0~40.8）And 49.4%（95% CI: 38.1~60.7）；

• The median Duration of Response (DOR) and Progression-Free Survival (PFS) were 339 days (95% CI: 149~NE) and 176 days (95% CI: 91~NE), respectively, while the Overall Survival (OS) has not yet been reached.

In terms of safety, 95.1% of patients experienced cytokine release syndrome (CRS), with 3.7% of patients experiencing grade ≥3 CRS. Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 8.6% of patients, with no cases of grade ≥3 ICANS. The treatment-related mortality rate was 1.2%.

In addition to the recently approved HR001, the treatment for multiple myelomaBCMA CAR-T Therapy HR003Previously, it was also included in the CDE's Breakthrough Therapy designation and is currently in Phase II clinical development.CD19/CD22 Dual-Target CAR-T Therapy HR004It has also entered the Phase I clinical trial stage for the r/r B-ALL indication; additionally, there is another product that has already been approved for clinical trials.CD70-Targeted CAR-THR010, for renal cell carcinoma, etc.Solid TumorTo carry out development.

Three CD19-targeted CAR-T products have been approved in China, including Axicabtagene Ciloleucel Injection approved in June 2021 from Fosun Kite, Relmacabtagene Autoleucel Injection approved in September 2021 from JW Therapeutics, and Naxibabtagene Autoleucel Injection approved in November 2023 from Hycan Bioscience.RanimiluceThisThe fourth approval; In addition, two more products are in the process of market application. The competition is fierce, and gaining a competitive advantage is not easy.

Sina Medicine Comprehensive

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