Jiangsu Medical Insurance Bureau Sets BCI Service Prices; TQ Pharma's TQC3721 for COPD Receives Breakthrough Therapy Designation

Amino Observation - Original Production by the Innovative Drug Team

Author | Huang Kai

/ 01 /

Market Express

1) Fosun Pharmaceutical Introduces New Drug for Alzheimer's Disease

On July 28, Fosun Pharmaceutical announced that its subsidiary, Fosun Pharmaceutical Industry, signed a licensing agreement with Neurokine. Under the agreement, Fosun Pharmaceutical Industry has been granted the rights to develop, register, manufacture, and commercialize the drug containing AR1001 molecule as its active ingredient within the agreed licensed territory (i.e., mainland China, Hong Kong, and Macao) and field (i.e., for the diagnosis, prevention, and treatment of Alzheimer's disease and other neurological disorders). According to the terms, Fosun Pharmaceutical Industry will pay up to RMB 150 million (including upfront payment and regulatory milestone payments) to Neurokine for this license.

2) Tigermed Purchases Partial Equity of Japan's MICRON

On July 29, Tigermed announced that its wholly-owned subsidiary, Tigermed Japan Co., Ltd., signed a "Share Transfer Agreement" with the original shareholders of Japan MICRON / MICRON Co., Ltd. to purchase part of their MICRON shares for a total purchase price of 484 million yen, approximately RMB 23.4771 million. After the completion of this transfer, Tigermed Japan will hold 56.37% of MICRON's shares. MICRON was established in 2005, headquartered in Tokyo, Japan, with over 160 employees. It is a CRO company specializing in medical imaging and clinical trial services.

/ 02 /

Pharmaceutical News

1) Innovent Bio's Masitide Injection Receives Clinical Approval

On July 29, according to the CDE website, Innovent Bio's mazdutide injection received clinical approval for the treatment of heart failure with preserved ejection fraction/mildly reduced ejection fraction in patients with obesity.

2) Qilu Pharmaceutical's QLM2012 Receives Clinical Approval

On July 29, according to the CDE official website, Qilu Pharmaceutical's QLM2012 received clinical approval for the treatment of adult schizophrenia.

3) GENRIX BIO's Selwevimab Injection Receives Clinical Approval

On July 29, according to the CDE website, GENRIX BIO's Serelumab Injection received clinical approval for passive immunization in children and adolescents aged 2 to under 18 suspected of rabies virus exposure.

4) 3SBIOINC's SSGJ-706 Injection Receives Clinical Approval

On July 29, according to the CDE website, 3SBIOINC's SSGJ-706 injection received clinical approval for the treatment of advanced non-small cell lung cancer as a single agent or in combination therapy.

5) CHIATAI TIANQING's Inhalation Suspension TQC3721 Granted Breakthrough Therapy Designation

On July 29, according to the CDE website, CHIATAI TIANQING's inhalation TQC3721 suspension is proposed to receive Breakthrough Therapy Designation for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD).

6) Henlius' Denosumab Biosimilar HLX14 Receives Positive Opinion from EMA's Committee for Medicinal Products for Human Use

On July 28, Henlius announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the marketing authorization for HLX14, the company’s self-developed biosimilar candidate of PROLIA/XGEVA (denosumab). The recommendation covers all indications approved in the EU for the originator product, spanning areas such as osteoporosis, prevention of skeletal-related events, and treatment of giant cell tumor of bone.

/ 03 /

Digital Healthcare Daily

1) Jiangsu Medical Insurance Bureau Announces Service Price Projects Related to Brain-Computer Interface

On July 29, the Jiangsu Provincial Medical Security Bureau released a public notice regarding medical service pricing for brain-computer interface-related services. The proposed pricing for non-invasive brain-computer interface fitting in Jiangsu Province is 966 yuan per session, invasive brain-computer interface implantation is 6,600 yuan per session, and invasive brain-computer interface removal is 3,200 yuan per session.

/ 04 /

Overseas Pharmaceutical News

1) Celcuity Announces Successful Phase III Clinical Trial of PI3K/Akt/mTOR Inhibitor for Breast Cancer

On July 28, Celcuity announced that its PI3K/Akt/mTOR inhibitor Gedatolisib achieved a clinically meaningful PFS improvement endpoint in the Phase III clinical trial for PI3KCA wild-type, HR+/HER2- breast cancer.

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