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 Reporting New Health team!
Policy Trends
On July 19, Li Li, Secretary of the Party Leadership Group and Director of the National Medical Products Administration, presided over an enlarged meeting of the Party Leadership Group to convey and study the spirit of the Third Plenary Session of the 20th Central Committee of the Communist Party, and to research and deploy measures for implementation.The meeting required a comprehensive understanding of the important reform deployments in the field of drug regulation made by the plenary session, systematic planning of policy measures to deepen the reform of the entire process of drug regulation, and promotion of the benign interaction between high-level drug safety and high-quality development of the pharmaceutical industry. Efforts should be made to improve the drug safety responsibility system, promote the interconnection and linkage of departmental regulatory responsibilities, local management responsibilities, and corporate primary responsibilities, achieving shared responsibilities, joint problem-solving, and concerted efforts. It is necessary to continuously deepen the reform of the review and approval system, increase support for the research and development of innovative drugs and medical devices, promote the inheritance and innovative development of traditional Chinese medicine, and fully support the high-quality development of the biopharmaceutical and medical equipment industries. The coordination and governance of "three medicines" should be promoted, the work of quality and efficacy consistency evaluation of generic drugs should be deepened and expanded, the supervision of selected drugs and medical devices in centralized procurement should be strengthened, and the regulation of the operation and use of drugs and medical devices in medical institutions should be enhanced to better serve and guarantee the overall situation of the reform of the medical and health system.- Management Requirements for Temporary Import and Use of Medically Needed Medical Devices in Clinical Settings Released and Implemented
On July 20, the National Medical Products Administration, together with the National Health Commission, issued the "Management Requirements for Temporary Import and Use of Clinically Urgently Needed Medical Devices in Medical Institutions," effectively improving the accessibility of urgently needed medical devices under special circumstances. The "Management Requirements" apply to Class II and Class III medical devices that are temporarily imported for clinical use by medical institutions due to urgent patient needs. These devices are already marketed abroad but have no equivalent products available in China, excluding equipment subject to large-scale medical device configuration licensing. Clinical urgency refers to situations where there are currently no effective treatment or prevention methods available in China, and the devices are required clinically to prevent or treat life-threatening diseases.Comment 21: Allowing medical institutions to temporarily import medical devices that are already marketed abroad but still lacking in China under specific circumstances directly addresses urgent clinical needs. The aforementioned "Management Requirements" represent an important supplement and improvement to the existing medical device regulatory system, clarifying the conditions, procedures, and responsibilities for temporary imports. This ensures both the flexibility to meet clinical needs and the safety and efficacy of medical device use, reflecting the scientific and humanistic nature of regulation.
Drug and Device Approval
On July 19, the supplemental indication application for Hansoh Pharma's self-developed Class 1 new drug, Almonertinib Mesylate Tablets (brand name: Amelotin), was accepted by the National Medical Products Administration (NMPA) for use as adjuvant therapy in adult patients with non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations following tumor resection.
- RemeGen's Telitacicept Approved for New Indication
On July 19, the latest announcement on the official website of China's National Medical Products Administration (NMPA) revealed that the new indication application for RemeGen's injectable Teyitaxip (RC18) has been approved. According to a previous press release by RemeGen, the approved indication this time is for rheumatoid arthritis (RA). This marks the second approved indication for Teyitaxip following the approval for systemic lupus erythematosus (SLE) in March 2021.
- Chipscreen Biosciences' PPAR Full Agonist Ciglitazon Sodium Tablets Approved for New Indication
On July 19, the latest announcement on the official website of China's National Medical Products Administration (NMPA) revealed that the new indication application for Chiral Bioscience's PPAR full agonist, Ciglitiazole Sodium Tablets, has been approved. The newly approved indication for Ciglitiazole Sodium is: in combination with metformin, for the treatment of patients with type 2 diabetes whose blood glucose levels are not well controlled by metformin monotherapy.
- Earnings Report Disclosure
On July 21, Pharmaron announced that the estimated net profit for the first half of the year would be RMB 1.055 billion to RMB 1.143 billion, representing a year-on-year increase of 34% to 45%. In the second quarter, with the initial recovery of global biopharmaceutical industry investment and financing, the company's revenue is expected to increase quarter-on-quarter compared to the first quarter of 2024, and achieve a slight year-on-year growth compared to the second quarter of 2023.
- Fuan Pharmaceutical Expects Net Profit of 205 Million to 225 Million Yuan for the First Half of 2024
On July 21, Fu'an Pharmaceutical announced that the net profit attributable to shareholders of the listed company for the first half of 2024 will be between RMB 205 million and RMB 225 million, representing a year-on-year increase of 27.42% to 39.85%. The net profit after deducting non-recurring gains and losses will be between RMB 190 million and RMB 210 million, representing a year-on-year increase of 32.90% to 46.89%.
Capital Market
On July 19, the International Cooperation Department of the China Securities Regulatory Commission issued a filing notice regarding the overseas issuance and listing of iFlytek Healthcare Technology Co., Ltd. and the "full circulation" of its unlisted domestic shares. The company plans to issue no more than 23,103,350 overseas-listed ordinary shares and list them on the Hong Kong Stock Exchange; 14 shareholders of the company intend to convert a total of 70,261,562 unlisted domestic shares into overseas-listed shares, which will then be listed and traded on the Hong Kong Stock Exchange.
- Asymchem Participates in Investment Fund Completing Private Equity Fund Registration
On July 19, Asymchem announced that it had received a notice stating that the Tianjin Haihe Asymchem Healthcare Industry Investment Fund Partnership (Limited Partnership) completed the filing procedures with the Asset Management Association of China in accordance with the requirements of laws and regulations such as the Securities Investment Fund Law and the Interim Measures for the Supervision and Administration of Private Investment Funds, and obtained the Private Investment Fund Filing Certificate.
- GRO Biosciences Completes Over $60 Million Series B Financing
On July 20, GRO Biosciences announced the completion of a $60.3 million Series B financing round, exceeding its target. The proceeds will be used to advance the company's lead program for treatment-resistant gout into clinical trials, expand the company’s pipeline, and further develop its Genetically Recoded Organisms (GRO) platform to create therapies incorporating multiple non-standard amino acids (NSAA). This round was co-led by new investors Atlas Venture and Access Biotechnology, with participation from existing investors including Leaps by Bayer, Redmile Group, Digitalis Ventures, and Innovation Endeavors. The completion of this Series B round brings GRO's total capital raised to over $90 million.
- The CPC Central Committee's Decision on Further Comprehensively Deepening Reform and Advancing Chinese-Style Modernization
To implement the strategic deployment made at the 20th National Congress of the Communist Party, the Third Plenary Session of the 20th Central Committee studied the issue of further comprehensively deepening reform and advancing Chinese-style modernization. It emphasized the need to deepen the reform of the medical and health system. A health-first development strategy will be implemented, the public health system will be improved, and social co-governance, medical-prevention coordination, and medical-prevention integration will be promoted. Capabilities in monitoring and early warning, risk assessment, epidemiological investigation, testing, emergency response, and medical treatment will be strengthened. The coordinated development and governance of healthcare, medical insurance, and pharmaceuticals will be promoted. High-quality medical resources will be expanded and decentralized, with a regional balance in layout; a tiered diagnosis and treatment system will be accelerated; the construction of closely-knit medical consortiums will be advanced; and grassroots healthcare services will be strengthened. Public hospital reforms oriented toward public interest will be deepened, a charge mechanism led by medical services will be established, the salary system will be improved, and a dynamic adjustment mechanism for staffing will be set up. The development of private hospitals will be guided and standardized. Healthcare supervision methods will be innovated. Mechanisms supporting the development of innovative drugs and medical devices will be improved, and mechanisms for the inheritance and innovative development of traditional Chinese medicine will be perfected.
Public Opinion Early Warning- TaiLin Pharmaceuticals Terminates Acquisition of Monoclonal Antibody Commercialization Rights
On July 19, TaiLin Pharma announced that the licensee, Green-Life Technology (Hong Kong) Company Limited (a wholly-owned subsidiary of the company), entered into a licensing and cooperation agreement with the licensor, Abcentra LLC, on June 21, 2022. The licensor conditionally agreed to irrevocably grant the licensee an exclusive perpetual license to commercialize the technology in mainland China, Hong Kong, Macao, Taiwan, Singapore, Malaysia, and Thailand. TaiLin Pharma stated that as of the announcement date, the project encountered several technical issues, and no milestone documents related to the current clinical trial stage have been received. Due to the inability of the licensee and licensor to reach an agreement on adjusting the delayed development timeline of the product, both parties agreed to terminate the acquisition. Therefore, no fees were paid to the licensor. Another significant reason for terminating the acquisition is that the company wishes to focus on its core capabilities and resources in bone health. Consequently, the company has entered into a termination agreement.
