BeijingSeptember 6, 2022/ PR Newswire /-- Biopharmaceutical high-tech company Nuocheng Jianhua (SEHK: 09969) announced today that the Drug Evaluation Center (CDE) of China's State Drug Administration (NMPA) has included the BTK inhibitor Obutini in the treatment of recurrent / refractory marginal zone lymphoma (MZL) as a priority review. Prior to this, CDE has accepted the application for new indications for the treatment of recurrent / refractory MZL patients (sNDA) by Obutini.

Dr Cui Jiansong, co-founder, chairman and CEO of Nuocheng Jianhua, said: "We are encouraged that this is the third indication of Obutini to be included in the priority review. There are unmet clinical needs in recurrent / refractory MZL. We look forward to benefiting these patients as soon as possible and providing them with better treatment options."

On August 12, the listing application of Obutini in the treatment of relapsed / refractory MZL patients was accepted by CDE. The NDA is based on data from a multicenter, open phase II clinical trial that evaluates the safety and efficacy of osbutini in the treatment of relapsed / refractory MZL.

At present, the treatment of recurrent / refractory MZL is limited, and no BTK inhibitor has been approved for recurrent / refractory MZL in China. We look forward to filling the gap in this field as soon as possible.

About Obutini.

Obutinib, a class 1 new drug developed by Nuocheng Jianhua, is a highly selective new BTK inhibitor designed to treat lymphoma and autoimmune diseases.

Obutinib was conditionally approved for the treatment of relapsed / refractory chronic lymphoblastic leukemia (CLL) / small lymphocytic lymphoma (SLL) and recurrent / refractory mantle cell lymphoma (MCL) in China on December 25, 2020. At the end of 2021, Obutinib was included in the national health insurance to benefit more patients with lymphoma.

In addition, multicenter, multi-indication clinical trials using orbutini alone or in combination are being carried out in China and the United States.

Obutinib is also conducting clinical trials in China for the treatment of a variety of B-cell lymphomas, including marginal zone lymphoma (MZL), central nervous system lymphoma (CNSL), Fahrenheit macroglobulinemia (WM) and diffuse large B-cell lymphoma (DLBCL).

Obutinib has been awarded the groundbreaking Therapy approval (Breakthrough Therapy Designation) by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent / refractory mantle cell lymphoma (R MCL).

Obutini is being evaluated in the global phase II clinical study of multiple sclerosis (MS) and in clinical trials in China for the treatment of systemic lupus erythematosus (SLE), primary immune thrombocytopenia (ITP) and neuromyelitis optici lineage disease (NMOSD).

About Nuocheng Jianhua

Nuocheng Jianhua (SEHK: 09969) is a commercial biomedical high-tech company specializing in the development of new drugs in the treatment of malignant tumors and autoimmune diseases. suitable for the treatment of lymphoma, solid tumors and autoimmune diseases. A number of new drug products are in the stage of commercialization, clinical and preclinical research and development. The company has branches in Beijing, Nanjing, Shanghai, Guangzhou, Hong Kong and the United States.

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