#FMCG Eight Talks##Consumption##你支持医疗反腐吗?##Medical##Health#Recently, AstraZeneca announced the acquisition of Gracell Biotech at a premium of 86%, which is the first Chinese biotech to be fully acquired by a multinational pharmaceutical company at a premium so far. China's Biotech, which has real innovative genes, was acquired by MNC (multinational pharmaceutical company) at a premium, and domestic innovative drugs went abroad with a new attitude. Looking back on 2023, Junshi Biosciences fired the first shot of domestic PD-1 drugs to break through the FDA, and domestic innovative drugs went overseas and BD (business development) cooperation continued. 2023 is a year of both opportunities and challenges for the industry, with sluggish investment and financing in the industry in the first half of the year and medical anti-corruption in the second half of the year......
Opening the U.S. market, BD (business development) for overseas licensing transactions, "going overseas" is undoubtedly one of the keywords in the pharmaceutical industry in 2023.
On October 29, 2023, Junshi Biosciences announced that toripalimab, a PD-1 inhibitor independently developed by the company, was officially approved by the U.S. Food and Drug Administration (FDA) for the full treatment of patients with advanced nasopharyngeal carcinoma, making it the first innovative biologic drug independently developed and produced in China approved by the FDA.
At the "Opportunity for Innovative Drugs" salon co-sponsored by Beijing Business Daily and Deep Blue Media Think Tank this month, Wang Peng, senior vice president of Xiantong Pharmaceutical, shared the necessity of domestic innovative drugs going abroad. He said that overseas means a broader and more mature market, which can bring more business benefits to enterprises. From the perspective of product strength, going to overseas markets is an important endorsement of a company's R&D capabilities, and it is also an important milestone for the company's subsequent development. Whether it is an innovative drug or some other products, going overseas is a very important direction.
Since the beginning of this year, pharmaceutical companies have accelerated the pace of internationalization. In the first three quarters, Hengrui Pharmaceutical continued to make efforts in overseas BD (business development) business, and realized the overseas authorization of a number of innovative drugs with independent intellectual property rights, such as PD-1 inhibitor camrelizumab, HER1/HER2/HER4 targeted drug pyrotinib, EZH2 inhibitor SHR2554.
China's original innovative drugs continue to attract global attention. The 65th Annual Meeting of the American Society of Hematology (ASH) is one of the largest international academic events in the field of hematology in the world. This year, Ascentage Pharma presented a number of latest developments in its blockbuster product Neric at the ASH Annual Meeting, which is the sixth consecutive year that the research results of Neric have been honored as an oral presentation at the ASH Annual Meeting.
As an emerging target, ADC drugs have also achieved fruitful results in going overseas. Last year, GSK acquired a portion of Hansoh Pharmaceutical's two ADC pipelines in two transactions totaling US$3.28 billion, and Nona Biologics, a subsidiary of Harbour BioMed, entered into an exclusive licensing agreement with Pfizer for the global clinical development and commercialization of human quercetin (MSLN) antibody conjugates (ADCs HBM9033 for up to US$1.05 billion in milestone payments.
In addition to the transactions between product pipelines, the industry saw the first case of a Chinese innovative pharmaceutical company being acquired by a multinational pharmaceutical company at the end of the year. On December 26, AstraZeneca announced the acquisition of Gracell Biologics, with a total transaction value of approximately US$1.2 billion, representing an 86% premium to Gracell's closing price on December 22, 2023. This is the first Chinese biotech to be fully acquired by a multinational pharmaceutical company at a premium so far. Gracell continues to operate in China and the U.S. as a wholly owned subsidiary of AstraZeneca.
When it comes to 2023, the events that will have a greater impact on the industry are also the medical anti-corruption storm, which is far wider and deeper than in the past.
On July 28, 2023, a video conference was held in Beijing for the discipline inspection and supervision organs to cooperate with the mobilization and deployment of the national centralized rectification of corruption in the pharmaceutical field. The meeting pointed out that it is an inevitable requirement to focus on rectifying corruption in the pharmaceutical field to promote the implementation of the Healthy China strategy, purify the ecology of the pharmaceutical industry, and safeguard the vital interests of the masses. It is necessary to stimulate the endogenous power to fulfill the main responsibility with the external thrust of supervision, and carry out in-depth systematic governance of the whole field, the whole chain and the full coverage of the pharmaceutical industry. Intensify discipline and law enforcement, keep a close eye on leading cadres and personnel in key positions, persist in investigating bribery and bribery together, and concentrate on investigating and prosecuting a number of corruption cases in the pharmaceutical field, so as to form a momentum of deterrence.
Subsequently, a number of listed pharmaceutical companies reported that the relevant person in charge was detained and investigated. For example, Zhou Wei, the actual controller and chairman of Weining Health, was placed on file for investigation and placed in custody on suspicion of bribery; Fan Zhi, the actual controller and chairman of Celun Biologics, was placed in custody and placed on file for investigation on suspicion of duty crimes; Su Qingcan, the actual controller and chairman of Huaxia Ophthalmology, was also placed in custody by the Shanghai Municipal Supervision Commission for personal reasons; and Zhou Jun, the former chairman of Shanghai Pharmaceutical, was suspected of serious violations of discipline and law and is undergoing disciplinary review and supervision investigation by the Shanghai Municipal Commission for Discipline Inspection and Supervision.
The fight against corruption continues. At the end of the month, the official website of the National Health Commission issued a document stating that the "Measures for the Management of Hospital Inspection Work (Trial)" and the new round of "Work Plan for Large Hospital Inspections (2023-2026)" jointly issued by the National Health Commission, the State Administration of Traditional Chinese Medicine, and the National Bureau of Disease Control and Prevention clearly stated that from December 2023 to the end of October 2026, a new round of large-scale hospital inspections will be carried out through self-inspection combined with on-site inspections.
This inspection will focus on the three major parts of party building, industry style construction, and operation management of public hospitals, and focus on the centralized rectification of corruption in the pharmaceutical field, the nine guidelines for the honest practice of medical institution staff, and the integrity of medical institutions and their staff across the country.
"Innovation" is still the main theme of the entire industry. In January 2023, the State Food and Drug Administration issued the "Several Measures on Further Strengthening the Scientific Supervision of Traditional Chinese Medicine and Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine", proposing 35 specific measures from nine aspects to promote the construction of a scientific supervision system for traditional Chinese medicine with Chinese characteristics. In March of the same year, the State Food and Drug Administration issued the "Drug Evaluation Center to Accelerate the Review of Marketing Authorization Applications for Innovative Drugs (Trial)" to encourage innovative drug R&D institutions to increase investment and improve innovation capabilities.
The results of the 2023 adjustment of the National Medical Insurance Drug List were officially released on December 13, 2023. A total of 126 drugs have been added to the National Medical Insurance Drug Catalogue and 1 drug has been transferred out of the catalogue. 143 off-list drugs participated in the negotiation or bidding, of which 121 drugs were successfully negotiated or bidd, with a negotiation success rate of 84.6% and an average price reduction of 61.7%, which was basically the same as in 2022. Among them, the success rate of innovative drug negotiation is high, the average reduction rate is low, and 70% of innovative drugs have been renewed at the original price.
According to Huang Xinyu, director of the Department of Pharmaceutical Management of the National Health Insurance Administration, the support of the National Health Insurance Administration for innovative drugs includes the establishment of a dynamic adjustment mechanism for the medical insurance catalogue to adapt to the access of new drugs, and the establishment of a dynamic adjustment mechanism for the catalogue once a year, shortening the adjustment cycle from the original maximum eight years to one year; The rules for the negotiation and renewal of innovative drugs to support the development of innovative drugs have also been improved, and the number and reduction of price reductions of drugs for renewal and new indications have been appropriately controlled, so as to give new drug companies a stable expectation.
Deng Zhidong, general manager of Hainan Boao Medical Technology Co., Ltd., told a reporter from Beijing Business Daily that the keywords of the pharmaceutical and health industry in 2023 are rapid development, technological innovation, medical insurance centralized procurement, digital transformation, etc., among which in terms of medical insurance centralized procurement, the ability of medical insurance to control costs has been enhanced, and it has also provided scale effects and market opportunities for enterprises. In addition, a series of policy reforms and institutional innovations will be launched in 2023 to promote the high-quality development of the industry and a healthy industrial ecology.
Beijing Business Daily reporter |
Image source: AstraZeneca's official website
Edited by Topol