Yimiao Shenzhou Announces Initiation of Phase I Clinical Trial for IM19 CAR-T Therapy in Relapsed/Refractory Non-Hodgkin Lymphoma

On July 7, 2020, Beijing Yimiaoshenzhou Medical Technology Co., Ltd. announced that the clinical trial of IM19 for the treatment of relapsed/refractory non-Hodgkin lymphoma had passed the ethical review by Beijing Cancer Hospital and was about to commence a Phase I clinical trial. The purpose of this trial is to evaluate the safety and preliminary efficacy of IM19.

Previously, Yimiaoshenzhou partnered with Simcere Pharmaceutical Group, under which Simcere will be responsible for the registration and commercialization of IM19 in China and select overseas markets. Yimiaoshenzhou will receive upfront payments, milestone payments, and sales royalties.

IM19 is a CD19-targeted chimeric antigen receptor T-cell injection.On April 15, 2020, IM19 received implicit approval for clinical trials from the National Medical Products Administration.

Previously, Yimiaoshenzhou collaborated with Beijing Cancer Hospital to complete an investigator-initiated clinical study. In this study, a total of 22 patients with relapsed or refractory non-Hodgkin lymphoma were enrolled. The objective response rate (ORR) for IM19 monotherapy reached 73%, demonstrating a favorable safety profile.Data on progression-free survival and pharmacokinetics in subjects indicate that IM19 has the potential to become a domestically developed, original CAR-T cell therapy for long-term suppression of tumor recurrence.

Song Yuqin, Director of the Lymphoma Department, Peking University Cancer HospitalThe professor stated, “Preliminary research indicates that IM19 CAR-T cell therapy demonstrates favorable efficacy and safety in the treatment of relapsed/refractory non-Hodgkin lymphoma, warranting further registrational clinical studies. Currently, there is a lack of effective therapeutic options for patients with relapsed/refractory lymphoma, particularly those with aggressive subtypes characterized by rapid disease progression. There is an urgent clinical need for novel therapies. We support the initiation of registrational clinical trials for candidate new drugs with potential favorable efficacy and safety profiles, aiming to expedite their market approval and provide new treatment options for patients and clinicians.”

He Ting, Founder and Chairman of YimiaoshenzhouThe doctor stated, “Previous research data indicate that IM19 demonstrates outstanding safety and efficacy in the treatment of relapsed or refractory aggressive lymphoma. With the initiation of clinical trials, the development of IM19 has officially entered a new phase. We are pleased to establish a strategic partnership with Simcere Pharmaceutical Group, leveraging its strong network and extensive experience in the domestic market to significantly accelerate the development and commercialization of IM19 in the field of hematologic malignancies.”

Ren Jinsheng, Founder and Chairman of Simcere Pharmaceutical GroupMr. [Name] stated, “IM19 is a globally innovative, next-generation gene and cell therapy that significantly enhances drug safety and efficacy compared to traditional treatment modalities, bringing new hope for curing cancer. This collaboration holds significant strategic importance, as it will leverage complementary strengths in clinical development and commercialization to achieve mutual benefits and win-win outcomes. We will work together to fulfill our mission of ensuring patients gain earlier access to more effective therapies.”

Yimiaoshenzhou Medical Technology is a leading gene and cell therapy company in China. The company possesses an independently developed gene and cell technology platform, featuring core technologies such as large-scale viral vector preparation and primary immune cell processing. Its R&D pipeline includes multiple CAR-T cell therapy drugs targeting advanced-stage cancer treatment, and it has obtained two Investigational New Drug (IND) approvals.

Simcere Pharmaceutical is a pharmaceutical company rapidly transforming into one driven by innovation and R&D, committed to “enabling patients to access more effective medicines sooner.” It has established three R&D centers in Nanjing, Shanghai, and Boston, and was approved by the Ministry of Science and Technology of China to establish the “State Key Laboratory of Translational Medicine and Innovative Drug Development.” The company focuses on three therapeutic areas—oncology (including cell therapy), central nervous system disorders, and autoimmune diseases—boasting a diversified and leading portfolio of innovative products. A pioneer in exploring open innovation models within the industry, Simcere has forged partnerships with leading pharmaceutical and biotechnology companies both domestically and internationally, facilitating the realization in China of global life science R&D achievements, benefiting more patients, and contributing to the Healthy China initiative.