Fosun Pharma Plans to Reduce Stake in Shanhé Pharmaceutical Excipients by Up to 1%

Jul 01, 2024 21:00 CST Updated 21:00

IASO Biotechnology

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Source: 21st Century Economic Report

Editor | Zhang Weixian, Xu Qiulian

Welcome to follow the latest events in the pharmaceuticals and health industry with the 21st Century Economic Report's New Health team!

Policy Trends

Lei Haichao Appointed as Director of the National Health Commission

On June 28, the Standing Committee of the National People's Congress decided on the appointment and removal list (passed at the 10th meeting of the 14th Standing Committee of the National People's Congress), removing Ma Xiaowei from the position of Director of the National Health Commission, and appointing Lei Haichao as the Director of the National Health Commission.

Review: Lei Haichao graduated successively from Weifang Medical College, Shandong Medical University, and Shanghai Medical University. He has served as Deputy Director and Director of the Department of Policy and Regulations at the Ministry of Health, Deputy Director of the Beijing Municipal Health Bureau, and Deputy Director and Director of the Beijing Municipal Health and Family Planning Commission. After 2018, Lei Haichao became the Party Secretary and Director of the Beijing Municipal Health Commission. As an official with nearly a hundred articles published on CNKI, Lei Haichao focuses on topics such as public health and reform of public hospitals.

2024 National Medical Insurance Catalog Adjustment Plan Announced

On June 28, the official website of the National Healthcare Security Administration announced the "Work Plan for the Adjustment of the 2024 National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Directory." The adjustment work for the 2024 National Medical Insurance Drug Directory will officially begin on July 1. This work plan has undergone minor adjustments in three main areas: First, regarding application conditions. The time requirements for drug approval and modification of indications have been extended according to the rules, allowing drugs approved for marketing or with modified indications after January 1, 2019, to submit applications. Second, regarding the scope of drugs to be removed. Regular directory drugs that have not been supplied to designated medical institutions in the past three years, as well as negotiated drugs that have failed to ensure market supply as per the agreement, are listed as key considerations to strengthen supply assurance management. Third, strengthening expert supervision and management. Clear rules for expert participation and selection criteria have been established, enhancing professional training and guidance for participating experts to improve the scientific and standardized nature of review calculations.

21 Comments: From the perspective of adjustment direction, this year's catalog adjustment will not only add negotiated drugs that fail to ensure market supply as stipulated in the agreement to the list of drugs to be removed, but also introduce clauses on ensuring drug supply in the agreement text. These clauses will be incorporated into assessment management to urge pharmaceutical companies to ensure market supply after their drugs are included in the medical insurance catalog through negotiation.

Drug and Device Approval

Zhejiang Borui Biopharmaceutical Co., Ltd.'s Tocilizumab Biosimilar Approved for Marketing in China

On June 28, Hangzhou BozhiRui Biopharmaceutical Co., Ltd., a subsidiary of Zhejiang Borui Biopharmaceutical Co., Ltd., announced that its developed and produced Tocilizumab Injection (brand name: Anbaixin) has officially been approved for marketing by the National Medical Products Administration (NMPA) in China. The drug is indicated for the treatment of Rheumatoid Arthritis (RA), Systemic Juvenile Idiopathic Arthritis (sJIA), and Cytokine Release Syndrome (CRS).

IASO Bio's GPRC5D-Targeted CAR-T Product Approved for Clinical Trials

On June 28, IASO Bio announced that the Investigational New Drug (IND) application for its self-developed fully human GPRC5D-targeted CAR-T product RD118 received tacit approval from the China National Medical Products Administration (NMPA) for the proposed treatment of relapsed/refractory multiple myeloma (RRMM).

CSPC’s Anti-PD-1 Monoclonal Antibody Approved in China

On June 28, the official website of the China National Medical Products Administration showed that the Class 1 new drug Enlasumab Injection, developed by Jushi Biopharmaceuticals of CSPC Group, has been approved for marketing in China. According to an earlier announcement by CSPC Group, this product was approved for the treatment of patients with recurrent or metastatic cervical cancer who are PD-L1 positive and have failed at least one line of platinum-based chemotherapy.

BeiGene's Anti-PD-1 Monoclonal Antibody Approved for New Indication

On June 28, the official website of the China National Medical Products Administration showed that BeiGene's PD-1 inhibitor, tislelizumab, had received approval for a new indication. According to a previous press release by BeiGene, the approved indication this time is: in combination with etoposide and platinum-based chemotherapy for the first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).

Hengrui Medicine's Henggeliejin Approved for New Indications

On June 28, the official website of the China National Medical Products Administration showed that Hengrui Medicine's SGLT2 inhibitor, Prolin Hengli Net Tablets, had received approval for a new indication. Hengrui Medicine stated that the approved indication is: when blood sugar control is inadequate with metformin hydrochloride alone, this drug can be used in combination with metformin hydrochloride and DPP-4 inhibitor Repaglinide Phosphate to improve blood sugar control in adult patients with type 2 diabetes, in conjunction with diet and exercise.

21 Comments: According to the Evaluate Pharma database, the global sales of SGLT2 inhibitor-related products in 2023 amounted to approximately $15.568 billion. To date, there are more than 10 SGLT-2 inhibitor products available globally, including AstraZeneca's Dapagliflozin, Johnson & Johnson's Canagliflozin, Boehringer Ingelheim's Empagliflozin, Merck's Ertugliflozin, Sanofi's Sotagliflozin, Astellas Pharma's Ipragliflozin, Chugai Pharmaceutical's Tofogliflozin, Taisho Pharmaceutical's Luseogliflozin, and Hengrui Medicine's Hengli Gliflozin.

Bio-Thera's Novel Antithrombotic Drug Approved for Marketing in China

On June 28, Bio-Thera Solutions announced that the company had received the Drug Registration Certificate issued by the National Medical Products Administration for its Citrate Bevilimab Injection (BAT2094, trade name: Betaning®). The drug is indicated for patients with acute coronary syndrome undergoing percutaneous coronary intervention (including coronary stent implantation) to reduce the risk of acute occlusion, stent thrombosis, no-reflow, and slow-flow. On the same day, Bio-Thera Solutions received a one-time upfront payment of US$10 million from STADA Arzneimittel AG for BAT2506 (Golimumab).

PrimaPharm's Posaconazole Injection Receives NMPA Marketing Approval in China

On June 30, Prinpharm announced that it had recently received the drug registration certificate for posaconazole injection issued by the National Medical Products Administration. Posaconazole injection is suitable for patients aged 18 and above who are at increased risk of these infections due to severe immunodeficiency, such as patients who develop graft-versus-host disease (GVHD) after hematopoietic stem cell transplantation (HSCT) or patients with hematological malignancies experiencing prolonged neutropenia caused by chemotherapy.

Capital Market

Tong Ren Tang Medical and Elderly Care Submits Listing Application to HKEX

On June 28, according to the disclosure on the Hong Kong Stock Exchange's official website, Beijing Tongrentang Medical & Elderly Care Investment Co., Ltd. (hereinafter referred to as "Tongrentang Medical & Elderly Care") submitted an application for listing on the Main Board of the Hong Kong Stock Exchange, with CICC acting as its exclusive sponsor. If Tongrentang Medical & Elderly Care successfully goes public this time, Tongrentang, a China Time-honored Brand enterprise, will also welcome its fourth listed company, following the previous listings of its subsidiaries Tongrentang Co., Ltd., Tongrentang Technology, and Tongrentang Chinese Medicine.

Shixi Bio Completes Tens of Millions of Angel+ Round Financing

On June 28, Shixi (Guangzhou) Biotechnology Co., Ltd. announced that it had recently completed an angel+ round of financing worth tens of millions of yuan. This round of financing was jointly led by Beijing Life Science Park Ventures, TianTu Investment, and Yiyi Capital, with follow-up investments from Xidian Venture Capital and BeiGene BioIsland Innovation Center, and continued support from Xiaochi Capital. Haoyue Capital served as the exclusive financial advisor. The funds will be used for the research and development of the company's core projects, clinical applications, and team expansion.

AbbVie Reaches $250 Million Acquisition Agreement

On June 28, AbbVie announced the acquisition of Celsius Therapeutics for a payment of $250 million. Celsius Therapeutics is a clinical-stage biotechnology company focused on developing novel drugs for the treatment of inflammatory diseases. The company’s lead candidate drug, CEL383, is a potential “first-in-class” TREM1-targeting antibody for the treatment of inflammatory bowel disease (IBD).

Industry Highlights

Heyou Hospital to Open Soon

On June 28, Heyuan Hospital, a key construction project in Guangdong Province, will officially open. It is reported that the hospital has been in trial operation since June 3 and has now obtained the qualification for designated medical insurance services, enabling medical insurance settlement for outpatient and inpatient services.

And誉 Pharma Announces First Clinical Data of FGFR4 Inhibitor Combination Therapy

On June 28, Abbisko Therapeutics announced that it publicly presented for the first time at the 2024 ESMO-GI Congress the latest clinical trial data on the combination of its highly selective small molecule FGFR4 inhibitor, eparogatinib, with the anti-PD-L1 antibody atezolizumab for the treatment of advanced hepatocellular carcinoma. The cohort receiving eparogatinib 220mg BID in combination with atezolizumab demonstrated significant efficacy in FGF19-overexpressing hepatocellular carcinoma patients, with an objective response rate (ORR) reaching 50%.

Public Opinion Early Warning

Fosun Pharma Plans to Reduce Stake in Shanhe Pharmaceutical by No More Than 1%

On June 28, Shanhe Pharmaceutical Excipients announced that Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (referred to as Fosun Pharma), a shareholder holding 11.20% of the company's shares, plans to reduce its holdings by no more than 2.326 million shares, representing 1% of the company’s total share capital, through centralized bidding between July 22, 2024, and October 20, 2024, due to operational needs. The price of the reduction will be determined based on market prices and relevant regulations.

Lisheng Pharmaceutical Plans to Transfer 24.65% Equity of Tanabe Pharmaceutical to Grand Pharma for 120 Million Yuan

On June 28, Lisheng Pharmaceutical announced that, based on overall planning and market competition conditions, the company decided to publicly list the transfer of its 24.65% equity in Tianjin Takeda Pharmaceutical Co., Ltd. ("Takeda Pharmaceutical") at a minimum price of no less than 120 million yuan. During the listing period, Grand Pharmaceutical (China) Co., Ltd. ("Grand Pharmaceutical") became the sole intended transferee and ultimately acquired the equity for 120 million yuan. Both parties have signed the property rights trading contract, and the transfer payment will be made in one lump sum. This equity transfer aligns with the company’s strategic deployment, and its specific impact on the company's operating performance and financial condition will be subject to the year-end audit results.