Bayer and MSD's Heart Failure Drug Vericiguat Approved in China; AstraZeneca's Avitinib Rejected

[May 19, 2022/Medical News Overview] Zhejiang increases the medical insurance reimbursement rate for infants aged 0-6 and will include in vitro fertilization and others in medical insurance at an appropriate time; Chen Haohua, director of O&M Medical, resigned for personal reasons; Fosun Pharma's holding subsidiary signed an exclusive license and option agreement with VerImmune... Daily fresh pharmaceutical news and medical information, Speed Reading Society keeps you updated!

Policy Brief

Zhejiang Increases Medical Insurance Reimbursement Rate for Infants Aged 0-6, Timely Incorporation of IVF and Others into Medical Insurance

Recently, the Zhejiang Provincial Medical Insurance Bureau released the "Notice of the Zhejiang Provincial Medical Insurance Bureau on Supporting 'Zhe You Shan Yu' to Promote the Work of Better Birth and Upbringing (Draft for Soliciting Opinions)." The notice pointed out that the reimbursement rate of medical insurance for infants aged 0-6 will be increased. The basic medical insurance reimbursement rate for infants aged 0-6 will be increased by about 10 percentage points compared with ordinary urban and rural residents. In addition, the notice issued by Zhejiang proposed to formulate the medical service prices of assisted reproductive technologies such as artificial insemination and in vitro fertilization for the treatment of infertility and sterility, and to include them in the payment scope of maternity insurance in accordance with relevant national regulations at an appropriate time. (Zhejiang Provincial Medical Insurance Bureau)

Industry Economy Observation

AstraZeneca China Vice President Zhu Jiakang to Resign

Today, AstraZeneca announced internally that Ms. Zhu Jiakang, Vice President of AstraZeneca China and head of the business unit related to lung cancer targeted therapy and tumor immunotherapy, has decided to leave AstraZeneca China to pursue external development opportunities. Ms. Zhu Jiakang’s term will officially end on June 9, 2022. Before a successor is in place, the business unit related to lung cancer targeted therapy and immunotherapy of AstraZeneca China will be overseen by Mr. Chen Kangwei, General Manager of the Lung Cancer Business Unit. (Sina Medicine News)

Aomei Medical Director Chen Haohua Resigns for Personal Reasons

On the 19th, O'Med Medical announced that it had recently received a written resignation report from Chen Haohua, a director of the company. Due to personal reasons, Chen Haohua applied to resign from his position as a director of the company. After his resignation, Chen Haohua will no longer hold any position in the company or its holding subsidiaries. (Corporate Announcement)

Zhongxin Pharmaceutical: Securities Abbreviation to be Changed to "Darentang" Starting from May 26

Today, Zhongxin Pharmaceutical announced that, in view of the company's name now being changed to "Tianjin Pharmaceutical Daren Hall Group Co., Ltd.", upon the company’s application and after handling by the Shanghai Stock Exchange, the A-share stock abbreviation of the company will be changed from "Zhongxin Pharmaceutical" to "Daren Hall" effective from May 26th, while the stock code "600329" remains unchanged. (Corporate Announcement)

Fosun Pharma's Controlling Subsidiary Signs Exclusive License and Option Agreement with VerImmune

Today, Fosun Pharma announced that its holding subsidiary, Fosun Pharma USA, has signed an "Exclusive License and Option Agreement" with VerImmune. Under the agreement, VerImmune grants Fosun Pharma USA exclusive rights to clinically develop, import, and commercialize VERI-101, a virus-like particle-based cancer immunotherapy drug, within the territory (i.e., mainland China, Hong Kong, Macao, and Taiwan) and in the field (i.e., treatment, alleviation, diagnosis, or prevention of human or animal diseases) using its proprietary technology and patents. (Corporate Announcement)

AbbVie Expands into Treg Field with Nearly $50 Million to Advance IL-2 Therapy Development

Recently, AbbVie announced a collaboration with Cugene to jointly develop a project focused on interleukin-2 (IL-2) mutant proteins targeting regulatory T cells (Treg). AbbVie has the option to obtain exclusive licenses for certain IL-2 mutant protein programs, including a candidate drug named CUG252. Under the agreement, Cugene will receive $48.5 million in upfront payments and is eligible for development and regulatory milestone payments. Cugene will conduct Phase 1b clinical trials in patients with autoimmune and inflammatory diseases. If AbbVie chooses to acquire the development rights for the candidate product CUG252, it will be responsible for future clinical development, manufacturing, and commercialization activities. (WuXi AppTec)

SwanBio Secures $56 Million to Advance Clinical Development of Gene Therapy SBT101

Today, SwanBio Therapeutics announced the completion of a $56 million Series B financing. The proceeds will be used to support the clinical development of its lead gene therapy candidate, SBT101, for the treatment of adrenomyeloneuropathy. The Phase 1/2 clinical trial of SBT101 is expected to commence in the second half of this year. (WuXi AppTec)

Pharmaceutical News and Medical Information

Bayer/MSD Heart Failure Drug Vericiguat Approved in China

On the 19th, the NMPA official website announced that the innovative therapy vericiguat (trade name: Verquvo), jointly developed by Bayer and Merck, has been approved for marketing through priority review. It is indicated for adult patients with symptomatic chronic heart failure with reduced ejection fraction (ejection fraction <45%) whose condition has stabilized after recent decompensated heart failure treated intravenously, to reduce the risk of hospitalization for heart failure or the need for emergency intravenous diuretic treatment. (Sina Medicine News)

Aisen Pharma's Aventinib Rejected for Approval

On the 19th, the NMPA issued a notice stating that Avitinib was not approved this time. Avitinib is a third-generation EGFR-TKI independently developed by AceMed, targeting EGFR-sensitive mutations and T790M mutations. It holds a global compound patent (PCT International Patent Publication No.: WO2014/025486A1) and is mainly used to treat non-small cell lung cancer with positive EGFR T790M mutations. As the first domestically produced third-generation EGFR-TKI to apply for marketing in China, Avitinib submitted its marketing application in June 2018. However, its review process has been delayed for nearly four years. During the supplementary data period, it was overtaken by Hansoh Pharma's Almonertinib and Allist's Furmonertinib successively. (NMPA)

Henlius' Anti-PD-1 Monoclonal Antibody Achieves Dual Primary Endpoints in Phase 3 Clinical Trial for First-Line Treatment of Esophageal Squamous Cell Carcinoma

On the 18th, Henlius announced that the innovative PD-1 inhibitor Serplulimab developed by the company, in combination with chemotherapy as a first-line treatment for patients with locally advanced/metastatic esophageal squamous cell carcinoma, reached both primary endpoints of progression-free survival and overall survival in a planned interim analysis of the phase 3 clinical study ASTRUM-007, as assessed by the Independent Data Monitoring Committee. (WuXi AppTec)

Axsome's Depression Therapy AXS-05 Phase II Trial Successful

Recently, Axsome Therapeutics announced the publication of positive results from the Phase II Ascend clinical trial of AXS-05 for the treatment of major depressive disorder (MDD) in the American Journal of Psychiatry. The published Phase II trial results showed that, compared to moderate to severe MDD patients treated with bupropion alone, patients treated with AXS-05 experienced rapid, substantial, and statistically significant improvements in depressive symptoms and remission induction. In addition, the remission rate for patients using AXS-05 significantly increased by the second week of treatment and at every subsequent time point. (Sina Medicine News)

Puli Pharmaceutical: Levetiracetam Injection Approved in the UAE

On the 19th, Prulifarm announced that the company had recently received the approval notice for Levetiracetam Injection issued by the UAE Ministry of Health and Prevention. Levetiracetam Injection is an anti-epileptic drug. (Corporate Announcement)

Hengrui Medicine Receives Approval for Clinical Trials of Two Drugs

Today, Hengrui Medicine announced that the company's drug HRG2005 inhalant and its subsidiary's drug HR18034 for injection have received clinical trial approval notices. This is the first clinical application for both HR19024 injection and HRG2005 inhalant; target and indication information has not yet been disclosed. (Corporate announcement)