On January 25, 2024, Tianjin Angsai Cell Genetic Engineering Co., Ltd., a subsidiary of Hanlian Pharmaceutical, was approved for another clinical IND of a new stem cell drug declared to the Drug Evaluation Center of the State Medical Products Administration. Up to now, Han's has applied for IND for 8 new stem cell drugs and obtained clinical trial approval.

Reception number: CXSL2300760

Drug name: Mesenchymal stem cells for injection (umbilical cord)

Applicant: Tianjin Angsai Cell Genetic Engineering Co., Ltd

Indications: Acute ischemic stroke

Registration classification: Class 1

With the approval of the State Medical Products Administration, the mesenchymal stem cells (umbilical cord) for injection independently developed by Han's jointly meet the relevant requirements of drug registration and agree to carry out clinical trials for acute ischemic stroke. Umbilical cord mesenchymal stem cells are perinatal stem cells, which have the advantages of rich sources, convenient collection, no ethical barriers, large number of stem cells, low immunogenicity, strong proliferation and differentiation ability, and easy large-scale preparation, and have a wide range of practical applications.

Tianjin Angsai Cell Genetic Engineering Co., Ltd. is the legal entity of the National Engineering Research Center for Cell Products and a holding subsidiary of Hanlian Pharmaceutical. Prior to this, Hanlian Pharmaceutical has applied for IND applications for 7 new stem cell drugs and obtained clinical trial approval, which can be used for traumatic spinal cord injury, acute respiratory distress syndrome, chronic acute (subacute) liver failure, refractory acute graft-versus-host disease, diabetic foot, severe lower extremity ischemia, etc.

Stroke, commonly known as "stroke", is an acute cerebrovascular disease. According to statistics, 1 in 4 people in the world will have a stroke. Every 6 seconds, 1 person dies from a stroke, and every 6 seconds, 1 person is disabled by a stroke. Ischemic stroke accounts for 85% of strokes. [1]

Stem cell therapy for stroke has shown great potential, and many studies have shown that mesenchymal stem cell transplantation is one of the effective treatments that is expected to promote the recovery of neurological function in stroke patients. [2] The Han joint R&D team has conducted in-depth research on the therapeutic effect of stem cells on stroke, and the research results have been published internationally and unanimously recognized by international peers.

The approval of this clinical trial is expected to provide new treatment options for patients with ischemic stroke and provide medical staff with more weapons when treating the disease. It is expected that this new drug will achieve good efficacy in clinical trials and bring good news to patients as soon as possible.

Hanlian Pharmaceutical Division, a subsidiary of Han's United Group, is mainly engaged in the research and development of new cell drugs, with a number of stem cell new drug platforms, located in Tianjin, Beijing and France, involving the research and development of new cell drugs in multiple dosage forms, more than a dozen indications, and rich follow-up pipelines. At present, it has independently developed more than 10 new stem cell drugs, which is at the forefront of the research and development of new stem cell drugs in China, promoting the high-speed and high-quality development of our country's stem cell technology industry.