SHANGHAI, March 27, 2024 /PRNewswire/ -- Keji Pharmaceutical (stock code: 2171.HK), an innovative CAR-T cell therapy company focused on treating hematologic malignancies and solid tumors, announced its 2023 results.

Quick overview of performance highlights

• Saikaize(Zevokiolense injection, CT053) New drug marketing application approved by the State Drug Administration
• CT041 received IND approval from the National Drug Administration for adjuvant treatment of pancreatic cancer with positive Claudin18.2 expression
• CT011 received IND approval from the National Drug Administration to treat GPC3-positive stage IIIa hepatocellular carcinoma with a risk of recurrence after surgical resection
• Two hepatocellular carcinoma patients treated with topical treatment in combination with GPC3 CAR-T cell therapy achieved disease-free survival of more than 7 years
• CT071 received FDA approval from IND to treat relapsed/refractory multiple myeloma or relapsed/refractory primary plasmacytic leukemia
• The development of a proprietary CarCelerate technology platform can reduce production time to around 30 hours; the platform has already been used on the CT071
• Keji Pharmaceutical and Huadong Pharmaceutical about commercializing Kaize in mainland ChinaSign a cooperation agreement
• Koji Pharmaceuticals and Medner launch a cooperation agreement to study the combined effects of CT041 and mRNA cancer vaccines

Dr. Li Zonghai, founder, chairman of the board of directors, CEO and chief scientific officer of Keji Pharmaceuticals, said:“In 2023, Keji Pharmaceutical still has the vision of 'science and technology innovation helps the world', and is committed to strengthening teamwork and improving operational efficiency. We have made significant progress in registering innovative products and promoting clinical research and new technology platforms. At the same time, we have reached several important milestones in clinical research, registration and business development for different candidate products. We are optimistic that we will face and overcome the challenges ahead with resilience and determination to advance our innovative cell therapies.”

Saikaize(Zevorki Orense injection,CT053)It is an all-human B-cell mature antigen (BCMA) autologous CAR-T cell candidate product for the treatment of recurrent or refractory multiple myeloma. Keji Pharmaceutical received a notice from the State Drug Administration on March 1, 2024 to approve Saikaize with conditionsNew drug marketing application (approval date February 23, 2024) for the treatment of adult patients with recurrent or refractory multiple myeloma who have progressed after at least 3 lines of treatment (at least one proteasome inhibitor and immunomodulator has been used). Updated data from the 3-year follow-up of the phase I trial (NCT03975907) conducted in China was presented in the form of a poster at the 2023 American Society of Hematology (“ASH”) Annual Meeting in December 2023.

CT041It is an autologous humanized CAR-T cell candidate targeting Claudin 18.2 (CLDN18.2) (a membrane protein that is highly expressed in some cancers). As of the announcement date, according to our data, CT041 is the world's first CAR-T cell candidate to treat solid tumors to enter phase II clinical trials. CT041 was approved by IND by the State Drug Administration in April 2023 for adjuvant treatment of pancreatic cancer with positive Claudin18.2 expression (CT041-ST-05, NCT05911217). In May 2023, phase 2 of the US and Canada Phase 1b/2 clinical trial (NCT04404595) was launched to treat patients with advanced gastric cancer/esophagastric junction adenocarcinoma who had received at least a previous second-line treatment that failed to express positive Claudin 18.2. Updated data from the CT041 US Phase 1b study (NCT04404595) was presented in the form of a poster at the 2024 American Society of Clinical Oncology Gastrointestinal Tumors Symposium (“ASCO GI”).

CT011It is an autologous CAR-T cell candidate product targeting Glypican-3 (GPC3). CT011 was approved by IND from the China Drug Administration in January 2024 to treat patients with GPC3-positive stage IIIa hepatocellular carcinoma who are at risk of recurrence after surgical resection.

In July 2023, an article entitled “Combined local therapy and CAR-GPC3 T-cell therapy in advanced hepatocellular carcinoma: a proof-of-concept treatment strategy” (“Combined local therapy and T-cell therapy in advanced hepatocellular carcinoma: a proof-of-concept treatment strategy”) was published in “” CAR-GPC3 According to “Cancer Communication (London, England)”, patients receiving sequential transfusion of CAR-GPC3 T cells after receiving topical treatment achieved disease-free survival of more than 7 years.

CT071It is an autologous all-human CAR-T cell therapy candidate targeting G protein-coupled receptor group C group 5 member D (GPRC5D), using Keji Pharmaceutical's proprietaryCarceleratePlatform development for the treatment of recurrent or refractory multiple myeloma (R/R MM) and relapsed/refractory primary plasmacytic leukemia (R/R PPCl). CT071 was approved by the FDA by IND for the treatment of R/R MM and R/R PPCl on November 30, 2023. A clinical trial initiated by an investigator is being conducted in China to evaluate the safety and efficacy of CT071 in treating R/R MM and relapsed/refractory plasma cell leukemia (R/R PCL) (NCT05838131).

In January 2023, Keji Pharmaceutical and Huadong Pharmaceutical (Hangzhou) Co., Ltd., a wholly-owned subsidiary of Huadong Pharmaceutical Co., Ltd. (stock code: SZ.000963), announced the commercialization of Saikaize in mainland ChinaSign a cooperation agreement.

In August 2023, Koji Pharmaceuticals and Medina (NASDAQ: MRNA, “Medena”) initiated a cooperative agreement to study the combined effects of CT041 and Medner's experimental Claudin18.2 mRNA cancer vaccine.

About Keji Pharmaceutical

Keji Pharmaceutical (stock code: 2171.HK) is a biopharmaceutical company with operations in China and the US, focusing mainly on innovative CAR-T cell therapy for the treatment of hematologic malignancies and solid tumors. We have established a CAR-T cell research and development platform from target discovery, innovative CAR-T cell development, clinical trials to commercial-scale production. Through independent research and development of new technologies and a product pipeline with global rights, we solve the major challenges of CAR-T cell therapy, such as improving safety, improving the efficacy of treating solid tumors, and reducing treatment costs. Our mission is to be a global biopharmaceutical leader that brings innovation and differentiation to cancer patients around the world and makes cancer curable.

Forward-looking statements

All statements in this press release that are not historical facts or are unrelated to current facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, predictions, beliefs and expectations about future events as of the date of this press release. Such forward-looking statements are based on assumptions and factors beyond the Group's control. As a result, they are subject to material risks and uncertainties, actual events or results may differ materially from these forward-looking statements, and the forward-looking events discussed in this press release may not occur. These risks and uncertainties include, but are not limited to, details under the heading “Key Risks and Uncertainties” in our recent annual and interim reports and other announcements and reports posted on our corporate website. We make no representations or warranties about the fulfillment or reasonableness of any predictions, goals, estimates, or predictions in this press release, and should not rely on those predictions.

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