Simcere, Innovent, Keymed Biosciences, and Grand Pharmaceutical Submit IND Applications for Novel Class 1 Drugs to CDE

Jan 03, 2024 21:01 CST Updated 21:01

Innovent

High-end Biologics Developer

Novatim

Innovative Drug Developer for Tumor Immunotherapy

Innovent Bio

On January 3, according to the CDE official website, Innovent Bio's B7-H3 ADC IBI129 was filed for clinical trial in China for the first time (Acceptance No.:CXSL2400006）。

Globally, Innovent Bio registered and initiated a Phase I/II clinical trial on ClinicalTrials.gov in August last year. The trial is being conducted in Austria (Registration No.: NCT05991349). The Phase I clinical trial plans to enroll 22-180 patients, while the Phase II portion aims to recruit approximately 182 patients, with preliminary completion expected by November 2024.

B7-H3 is also an important immune regulatory protein in the B7 family, widely expressed in a variety of human malignant tumors. In addition to diseases with huge market potential such as breast cancer, liver cancer, and lung cancer, it also includes...Endometrial cancer, cholangiocarcinoma, colorectal cancer, and ovarian cancer, etc., have become emerging immunotherapy targets.

Novatim

On January 3, according to the CDE official website, Novatim Immune Therapeutics (Zhejiang) Co., Ltd.Novatim Immune Therapeutics (Zhejiang) Co., Ltd. has independently developed a new generation of CAR-T product KQ-2003, an autologous chimeric antigen receptor T-cell injection, and submitted a clinical trial application for Class 1 new drug in China, which has been accepted (Acceptance No.:CXSL2400005）。

KQ-2003 Autologous Chimeric Antigen Receptor T-Cell Injection is a next-generation CAR developed through independent research and innovation from the ground up.T product, capable of simultaneously targeting two therapeutic targets—B-cell maturation antigen (BCMA) and CD19—will bring new treatment hope and deep, lasting therapeutic effects to more patients with relapsed/refractory multiple myeloma in the future.

Currently, in the IIT study of KQ-2003 CAR-T Cell Injection for the treatment of patients with relapsed/refractory multiple myeloma, there are 10 evaluable patients. Among these 10 evaluable patients, the overall response rate (ORR) is 100%, with 5 patients achieving complete response (CR) and 5 patients achieving very good partial response (VGPR). The longest progression-free survival (PFS) has been maintained for 21 months. No cytokine release syndrome (CRS) of grade 3 or higher has occurred. Preliminary data indicate that KQ-2003 CAR-T Cell Injection demonstrates favorable safety and efficacy.

Grand Pharmaceutical Group Limited

On January 3, according to the CDE official website, ITM Solucin GmbH & Grand Pharmaceutical (China) Co., Ltd.'s self-developed Class 1 new drug, the radiopharmaceutical Lutetium [177Lu] Edotreotide Injection, obtained clinical approval for Class 1 imported chemical drugs from the Center for Drug Evaluation of the National Medical Products Administration.ShenPlease(Application No.:JXHL2400001）。

Lutetium [177Lu] Edotreotide Injection (ITM-11) is a Radiopharmaceutical Drug Conjugate (RDC) that utilizes radiopharmaceutical conjugation technology for targeted treatment of Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs). ITM-11 conjugates carrier-free 177Lu with a somatostatin analog, targeting and killing tumor cells by binding to somatostatin receptors (SSTR) highly expressed on the surface of GEP-NETs. It represents Peptide Receptor Radionuclide Therapy (PRRT) and is an RDC drug.One of the treatment methods.

Compared with the commonly used carrier-added 177Lu radionuclide products, the carrier-free 177Lu has higher specific activity and purity. Moreover, the production process generates fewer long half-life impurities and less radioactive contamination. The ITM-11 product has been granted orphan drug designation by the U.S. FDA and the European Medicines Agency (EMA) for the GEP-NETs indication. Overseas, a Phase III clinical trial comparing ITM-11 with Everolimus for this indication is already underway [1].

In December 2021, Grand Pharmaceutical Group Limited entered into a product strategic partnership with Germany's ITM Isotope Technologies Munich SE, obtaining exclusive development, production, and commercialization rights in Greater China (Mainland China, Hong Kong, Macao, and Taiwan) for three globally innovative RDC drugs developed by ITM, including: TOCscan® for the diagnosis of gastroenteropancreatic neuroendocrine tumors; ITM-11 for the treatment of gastroenteropancreatic neuroendocrine tumors; and ITM-41 for the treatment of malignant tumor bone metastases.

Simcere Pharmaceutical

On January 3, the CDE website announced that Shanghai Xianxiang Pharmaceutical Technology Co., Ltd., a subsidiary of Simcere Pharmaceutical, submitted a clinical application for the Class 1 new drug SIM0500 Injection, which has been accepted (Acceptance No.: CXSL2400001).

According to the official website of Simcere Pharmaceutical, SIM0500 is a potential best-in-class drug independently developed by the company.GPRC5D/BCMA/CD3 Multi-Specific Antibody is Being Developed for the Treatment of Multiple Myeloma. SIM0500, developed through a proprietary T-cell engager multi-specific antibody drug R&D platform, combines a self-developed low-affinity, highly targeted CD3-activating antibody with antibodies against tumor-associated antigens to form a tumor-targeting T-cell activating drug. It offers advantages such as excellent tumor-killing effects and good tolerability.

SIM0500 has the potential to overcome drug resistance caused by existing treatments, expand the patient population covered, and has demonstrated excellent anti-tumor activity in preclinical animal models with varying expression levels. It also offers multiple advantages such as low effective dosage and no tumor recurrence after discontinuation. Currently, Simcere Pharmaceutical has completed the simultaneous IND submission for SIM0500 in both China and the United States.

Editor: Zhu Di