Source: 21st Century Economic Report
Editor: Ji Yuanyuan, Xu QiulianWelcome to follow the latest events in the pharmaceuticals and health industry with the 21st Century Economic Report's New Health team!
Policy Trends
On November 12, the official WeChat account of the National Healthcare Security Administration announced that recently, the administration has expedited the standardization of medical service pricing projects and has issued 15 batches of project establishment guidelines. To meet the needs of critically ill patient care, the latest completed guidelines for comprehensive diagnostic examination projects include a new pricing category called "air medical transport" in the patient transfer services. This encompasses various types of aircraft, including fixed-wing planes and helicopters, providing patient transfer services. The prices will be market-regulated, allowing medical institutions to set their own charging standards. With the official establishment of the "air medical transport" pricing project, by the end of May 2025, after all provinces in China have aligned and implemented the project establishment guidelines, medical institutions across all regions will have a basis for charging for air medical transport services.Review: In medical rescue operations, aviation vehicles are subject to fewer geographical space limitations and offer much higher efficiency than other modes of transportation, allowing patients to gain more treatment time. With the regulatory effect of pricing policies, an increasing number of medical institutions will be willing to collaborate with aviation companies to provide air medical transfer services. This collaboration can build a three-dimensional rescue network that integrates air and ground resources while accelerating the healthy development of the aviation economy.
- Publication of the Implementation Opinions on the Vocational Skill Level Recognition for Long-term Caregivers
On November 12, the official website of the National Healthcare Security Administration published an article stating that recently, the National Healthcare Security Administration, together with the Ministry of Human Resources and Social Security, issued the "Implementation Opinions on Promoting the Vocational Skill Level Accreditation for Long-term Caregivers" to advance the professional development of long-term caregivers.The "Implementation Opinions" focus on addressing the pressing difficulties and concerns of long-term care service recipients and long-term care practitioners, accelerating the development of a vocational skill level certification system for long-term caregivers oriented towards job utilization. It emphasizes enhancing professional identity and a sense of belonging, and clarifies the relevant requirements for the vocational skill level certification of long-term caregivers.Drug and Device Approval
On November 12, the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) announced that Johnson & Johnson's Nicarelimab Injection is proposed to be included in the priority review, applicable for treating generalized myasthenia gravis (gMG) adult and adolescent patients (over 12 years old) who are autoantibody positive. Nicarelimab (Nipocalimab) is an investigational FcRn antibody that Johnson & Johnson acquired through a $6.5 billion acquisition of Momenta Pharmaceuticals. In August this year, the drug was submitted for marketing approval in the United States for the treatment of myasthenia gravis.
- Novartis Atricure is proposed to be included in the priority review
On November 12, the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) showed that Novartis' Atrasentan Hydrochloride Tablets are proposed for priority review. The indication is for reducing proteinuria in adult patients with primary Immunoglobulin A Nephropathy (IgAN) who are at risk of disease progression.
- Rongchang Bio's Telitacicept Granted Priority Review
On November 12, the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) showed that Rongchang Bio's Telitacicept is proposed for priority review. The indication is for use in combination with conventional therapies to treat adult patients with generalized myasthenia gravis (gMG).
- ST Baili: Subsidiary's Sugar-Reducing Tongluo Tablets Clinical Trial Application Approved
On November 12, ST Bailing announced that its wholly-owned subsidiary, Bailing Yuxiu (Zhuhai) Pharmaceutical Co., Ltd., had received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration. The clinical trial application for Tangning Tongluo Tablets submitted by Bailing Yuxiu has been approved, and the company is permitted to conduct Phase III clinical trials for the treatment of diabetic retinopathy.
- Fuyuan Pharmaceutical: Montmorillonite Powder Obtains Drug Registration Certificate
On November 12, Fuyuan Pharmaceutical announced that recently, its wholly-owned subsidiary Zhejiang Aisheng Pharmaceutical received the "Drug Registration Certificate" issued by the National Medical Products Administration for Montmorillonite Powder (specification: each sachet contains 3g of montmorillonite). Montmorillonite Powder is used for acute and chronic diarrhea in adults and acute diarrhea in children.
- Earnings Report Disclosure
On the evening of November 12, BeiGene (NASDAQ: BGNE; HKEX: 06160.HK; SSE: 688235.SH) released its Q3 2024 financial report for the U.S. market and key financial data announcement for the A-share market. In Q3, BeiGene achieved revenue of 7.139 billion yuan, a year-on-year increase of 26.9%. Global product revenue reached 7.079 billion yuan, marking a year-on-year growth of 65.1%. For the first three quarters, BeiGene's total operating revenue amounted to 19.136 billion yuan, increasing by 48.6% year-on-year. Product revenue was 18.986 billion yuan, rising by 72.9% year-on-year.
- AstraZeneca's Third Quarter Revenue of $13.565 Billion
On November 12, AstraZeneca announced its Q3 financial report for 2024. The revenue for the third quarter was $13.565 billion, representing an 18% year-over-year increase. Product sales reached $12.95 billion, marking an 18% year-over-year growth. For the first three quarters, revenue amounted to $39.182 billion, with a 16% year-over-year increase. Product sales reached $37.576 billion, showing a 16% year-over-year growth.On November 12, Shenzhen Limango Biotechnology Co., Ltd. announced the successful completion of the first closing of its over RMB 100 million Series A financing round. This round was led by Fuhui Venture Capital, with participation from Junyi Investment and XtalPi, among others. The proceeds will primarily be used for IND applications for ultra-low-dose metabolism-enhanced CAR-T cell therapies, development of automated production processes, and acceleration of the clinical translation of metabolism-enhanced solid tumor cell treatments.
- Lanwei Medical: Shareholder Hailan Group Plans to Reduce Stake by No More Than 2%
On November 12, Lanwei Medicine announced that Hailan Group, a shareholder holding more than 5% of the company's shares, plans to reduce its shares in the company within 3 months after 15 trading days from the disclosure of this reduction plan announcement. The reduction will be carried out through centralized bidding and/or block trading, with no more than 7.9704 million shares (representing 2.00% of the total share capital after excluding the shares held in the company’s repurchase dedicated account).
Industry Highlights
On November 12, Jiuzhitang issued an announcement stating that the controlling shareholder and actual controller, Li Zhen Guo, signed a share transfer agreement with Heilongjiang Cheneng Gongda Venture Capital Co., Ltd. The agreement stipulates that Li Zhen Guo will transfer 53.5 million shares (6.25% of the company's total share capital) held in the company to Cheneng Venture Capital. The transaction price for these shares is based on the closing price of the company’s shares on the secondary market on the trading day prior to the signing of the agreement (November 8, 2024, at 7.56 yuan per share), set at 7.19 yuan per share. The total consideration for the share transfer amounts to approximately 385 million yuan.After the transfer is completed, Cheneng Venture Capital will become the controlling shareholder of Jiuzhitang, and the State-owned Assets Supervision and Administration Commission of the Heilongjiang Provincial People's Government will become the actual controller of the company. Li ZhenGuo's shareholding ratio is 18.91%, making him the second largest shareholder of the company.
Public Opinion Early WarningOn November 12, Hainan Haiyao announced that the company received the "Decision on Ordering Hainan Haiyao Co., Ltd. to Take Corrective Measures" from the Hainan Securities Regulatory Bureau on November 12, 2024. Upon investigation, the company has the following issues: First, Chongqing Tiandi Pharmaceutical Co., Ltd., a subsidiary, engaged in certain sales transactions in 2023 that lacked commercial substance, and revenue recognition was not adequately supported, resulting in inaccurate financial data disclosed in the company’s relevant periodic reports. Second, there is a situation of shared personnel between the company and its indirect controlling shareholder, Xinxing Cathay International Pharmaceutical Holdings Co., Ltd., which compromises the company’s independence, and the disclosure of the related situation does not match the actual circumstances. Third, the disclosure of information regarding the appointment and removal of certain senior management positions is inaccurate. The Hainan Securities Regulatory Bureau has decided to impose administrative regulatory measures ordering the company to make corrections.Hainan Haiyao stated that this administrative regulatory measure will not affect normal business management activities. The company will seriously learn from the experience, formulate a rectification plan, implement corrective actions, and timely submit a written rectification report.
