China Advances Pharmaceutical Reforms: Anti-Corruption Drive, Innovative Drug Pricing Liberalization, and Launch of New Migraine Therapy

This week, the General Office of the CPC Central Committee and the General Office of the State Council issued the "Implementation Plan for the Comprehensive Reform Pilot Program in the Pudong New Area (2023-2027)," which clearly states,In accordance with relevant regulations, new biopharmaceutical products are allowed to price by reference to international similar drugs, supporting the development of innovative drug and medical device industries.。

China's National Medical Products Administration and National Health Commission both held work meetings this week, emphasizing that the fight against corruption in the pharmaceutical sector should be treated as a top priority. They called for an unwavering commitment to deepening discipline and rectifying conduct, with a strict focus on top leaders. Meanwhile, health commissions in provinces such as Sichuan and Hebei have successively announced new rounds of inspection campaigns targeting large hospitals. Sichuan, in particular, published a list of 13 hospitals to be inspected, all of which are well-known Class III Grade A hospitals within the province.

The bankruptcy case of Boji Biomedical was disclosed by the Yuhang District People's Court of Hangzhou City, Zhejiang Province, marking the first domestic Biotech bankruptcy announcement in 2024. Executives of Philips and Medtronic China have been replaced. Additionally,Beijing's Largest Hospital Expected to Open in Q3Ustekinumab enters the billion-dollar club.

Jian Shi Ju has compiled more hot news as follows:

1. Pudong New Area Allows New Biopharmaceuticals to Be Priced by Reference to International Similar Drugs

On January 22, the "Implementation Plan for the Comprehensive Reform Pilot Program of Pudong New Area (2023-2027)" was released. The plan specifies that an industrial development ecosystem should be built — establishing a collaborative innovation mechanism for the biopharmaceutical industry and promoting clinical research cooperation among medical institutions, universities, and research institutes.In accordance with relevant regulations, new biopharmaceutical products are allowed to be priced by reference to international similar drugs., supporting the development of innovative drug and medical device industries.

At the same time, the "Plan" pointed out that the continuous optimization of drug and medical device management is necessary. An international medical service cluster will be built to expand the openness of healthcare services. Support for international medical institutions to establish medical facilities through joint ventures or cooperation is also included.

The "Plan" also requires exploring the formulation of ethical rules in global major cutting-edge technology fields such as artificial intelligence and biomedicine.Establish a collaborative review mechanism and build a fast track for ethical review.. Attract and cultivate international scientific and technological organizations, optimize the registration process, allow membership recruitment on a global scale, and establish a comprehensive regulatory mechanism.

2. NMPA Announces Key Points of Clean Government Work for 2024

On January 24, the National Medical Products Administration held a work conference on Party conduct and clean government construction, summarizing the 2023 work on Party conduct and clean government construction and deploying the 2024 work tasks.

The meeting pointed out that in 2024, the national drug regulatory system in China must continue to deepen the construction of political institutions and strengthen the discipline inspection organization within the drug supervision system; unwaveringly deepen rectification of conduct and discipline, and further implement the "Three-Year Action Plan for Conduct Improvement."

At the same time,In 2024, there will be a concentrated effort to address corruption in the pharmaceuticals sector; strengthen the education, supervision, and management of cadres.; Continuously deepen supervision, discipline enforcement, and accountability, strengthen the rigid constraints of discipline, play the role of the political inspection sword, and effectively create and consolidate a clean and upright political environment.

3. China's National Health Commission Arranges This Year's Pharmaceutical Anti-Corruption Work

On January 22, the National Health Commission held a meeting on inspection work to implement the spirit of the third plenary session of the 20th Central Commission for Discipline Inspection and the requirements of the "Central Inspection Work Plan (2023-2027)."

The meeting emphasized the need to keep a close watch on power and responsibility.Focus on the "top leader" and the leadership team, and focus on issues strongly raised by the public., and steadfastly and prudently carry out the inspection work of the Party Leadership Group, etc.The Party Leadership Group of the National Health Commission decided to establish 2 inspection teams to conduct routine inspections of 6 directly affiliated and connected units.。

The "Central Inspection Work Plan (2023-2027)" proposes to deepen the coordination and connection between inspection supervision and discipline supervision, inspection supervision, and resident supervision. It also aims to strengthen the collaboration between inspection supervision and organizational supervision, fully utilize the professional strengths and supervisory achievements of departments such as auditing, finance, and statistics, and enhance the synergy of supervision.

4. Multiple well-known tertiary hospitals listed for inspection

On January 23, the Health Commission of Sichuan Province announced that a new round of large-scale hospital inspections would be carried out across the province. The inspections will take place from January 2024 to the end of October 2026, with inspections at tertiary general hospitals lasting no less than seven days in principle. The focus of the inspections includes hospital party building, industry style construction, operation management, production safety, organization and implementation, among other aspects.

The Health Commission of Sichuan Province listed the names of 13 medical institutions that have been included in the inspection scope, in chronological order:Inspection to be carried out in 2024 at the Affiliated Hospital of North Sichuan Medical College, the First Affiliated Hospital of Chengdu Medical College, Sichuan Provincial Maternal and Child Health Care Hospital, and the Reproductive and Maternal & Child Hospital affiliated with Chengdu University of Traditional Chinese MedicineIn the next two years, Sichuan Provincial People's Hospital, Sichuan Provincial Cancer Hospital, Sichuan Third People's Hospital, Sichuan Fourth People's Hospital, Sichuan Fifth People's Hospital, and the Affiliated Hospital of Southwest Medical University will all be subject to inspections.

5. Henan Leads 23-Provincial Blood Dialysis Consumables Procurement, with Maximum Price Reduction of 74%

On January 24, the Henan Provincial Medical Insurance Bureau announced the tentative winning results of the representative products in the inter-provincial alliance procurement of blood dialysis. This blood dialysis centralized procurement covers 23 provinces including Henan, Shanxi, Inner Mongolia, Liaoning, Jilin, Heilongjiang, Anhui, Fujian, Jiangxi, Shandong, Hunan, Guangdong, Guangxi, and Hainan.

The selection rules for this centralized procurement are relatively moderate. Rule one sets a higher selection ratio, allowing products to be selected if they do not exceed 1.5 times the lowest price or achieve a 50% price reduction.A reduction of 40% can meet the second selection rule.. The Jian Shi Bureau found that the non-dedicated hemofiltration replacement fluid replenishment tube from Duan Yuan Medical Technology (Wuxi) Co., Ltd. was priced at 19.24 yuan, marking a 74% price reduction, the highest decrease. The price reductions for several other proposed selected products were approximately 40%.

1.2024 First Domestic Biotech Bankruptcy Liquidation in China

Jianshi Bureau learned this week that the Yuhang District People's Court of Hangzhou City, Zhejiang Province disclosed on January 12Bankruptcy Case of Boji BiomedicalProgress of handling. According to Interface News, Beijing Branch of Boji Biomedical Technology (Hangzhou) Co., Ltd., under Boji Bio, is undergoing a simplified cancellation process, with the application date being December 4, 2023.

Boji Biotech, established in 2017 with a paid-in capital of 30 million yuan, is a clinical-stage biotechnology company dedicated to the research and development of innovative drugs. Boji Biotech has seven products under development, with its two most advanced products, BJ-001 and BJ-005, currently in Phase I clinical trials in both China and the United States, targeting oncology indications.

2. WEGO Orthopaedics Apologizes for Alleged Commercial Bribery

The official website of Hubei Province's centralized drug and medical device procurement service platform recently released a statement of apology from Wego Orthopedics.

According to the statement, the Hubei Provincial Public Resources Trading Center issued a notice titled "Letter of Notification on the Rating Results of Dishonest Conduct in Pharmaceutical Pricing and Procurement." WEGO Orthopaedic Device Co., Ltd. took it very seriously and promptly responded and rectified the situation in accordance with relevant requirements outlined in documents such as the "Guiding Opinions of the National Healthcare Security Administration on Establishing a Credit Evaluation System for Pharmaceutical Pricing and Procurement."Weigao Orthopaedics deeply apologizes for the negative impact caused by this incident.。

WEGO Orthopaedics explained to Red Star News that,Commercial bribery cases were committed by dealers.In Hubei, the company operates under a distribution model, and the sales team does not directly interface with hospitals.

In November 2023, the Hubei Province Medical Device Centralized Procurement Service Platform released the "Announcement on Collecting the Notification Letter of Credit Rating Results for Dishonest Conduct in Pharmaceutical Pricing and Procurement," in which Wego Orthopedics and Kaili Tan were rated as dishonest. Kaili Tan told The Economic Information Daily,The Hubei distributor that the company cooperates with was involved in a case, and the relevant case was adjudicated in 2023.。

3. Philips and Medtronic China Executives Change

Medtronic announced this weekZang Jing, the newly appointed Vice President of Commercial Operations for China in the Surgical DivisionZang Jing was previously the Assistant Vice President of Boston Scientific and the business leader of the Interventional Cardiology Division, having served several pharmaceutical companies such as Lingfeng Pharmaceutical, Jiangsu Kangyuan Pharmaceutical, Xi'an Janssen, and Bayer. Zang Jing will report directly to Medtronic Vice President Yu Jing and join the Global Surgical Leadership Team and the Greater China Executive Committee.

In addition, the former Vice President and Financial Director of Philips Greater China, now CFO of North AmericaLiu Ling is set to return to China to assume the role of Chief Commercial Officer for Greater China.Liu Ling will lead all business functional departments and oversee the implementation of sales and commercial objectives.

4. Beijing's Largest Hospital Expected to Open in Q3

According to this week's report from the Beijing Daily, the Tongzhou branch of Anzhen Hospital has been basically completed and is currently coordinating the installation of medical equipment and finalizing work. It is expected to open for diagnosis and treatment in the third quarter of this year.

As the largest medical project under construction in Beijing,The Tongzhou Campus of Anzhen Hospital, covering an area of 340,000 square meters, will accommodate a daily outpatient and emergency volume of 6,500 visits and have 1,300 beds in the future., undertaking functions such as outpatient, emergency, medical technology, inpatient, scientific research, teaching, and rehabilitation care.

According to the public data from the China Government Procurement Network, as of January 23, 2024, multiple domestic and international companies, including Mindray Medical, United Imaging Healthcare, Siemens Healthineers, GE Healthcare, and Philips, have won bidding projects in the hospital district.

5. Ustekinumab Sales Break $10 Billion

On January 23, Johnson & Johnson announced its 2023 financial results, with total annual revenue of $85.2 billion, a year-on-year increase of 6.5%. Excluding the COVID-19 vaccine, the year-on-year growth was 9%. Among them,Stelara becomes Johnson & Johnson's best-selling product, growing 11.7% year-over-year to $10.858 billion in 2023, officially entering the billion-dollar club.

The patent for ustekinumab in the United States expired in September 2023. Currently, two biosimilar versions of ustekinumab have been approved globally. Analysts predict that sales may drop by $2 billion by 2024.

1. Pfizer's New Migraine Drug Orally Disintegrating Tablet Approved in China

On January 26, Pfizer China announced,Rimegepant Orally Disintegrating Tablets for Migraine Treatment Approved by China's National Medical Products Administration, for the acute treatment of migraine with or without aura in adults.

This drug is the world's first and only calcitonin gene-related peptide receptor antagonist utilizing patented orally disintegrating tablet technology. It is also currently the only drug approved in both the United States and the European Union with indications for both acute treatment and preventive treatment of migraine, and has been recommended by migraine guidelines in the United States, Europe, and China.

2. Acceptance of Aflibercept 8mg Marketing Application in China

Bayer announces that the Center for Drug Evaluation of the National Medical Products AdministrationThe marketing application for aflibercept 8mg for the treatment of neovascular (wet) age-related macular degeneration has been accepted.Chinese regulatory authorities are currently reviewing the research data.

Bayer's application this time is based on the positive results of the Phase III PULSAR clinical trial for nAMD: compared with the fixed 8-week dosing of aflibercept 2mg, aflibercept 8mg achieved the primary endpoint of non-inferiority in best-corrected visual acuity at week 48. Aflibercept 8mg has demonstrated stronger durability for the vast majority of patients, maintaining a dosing interval of 12 or 16 weeks.

3. Johnson & Johnson Submits Two New Drugs for Market Approval in China

On January 26, the official website of the Center for Drug Evaluation of China's National Medical Products Administration announced that two products from Johnson & Johnson had their marketing applications accepted, respectively.EGFR/MET Bispecific Antibody Therapy Amivantamab Injection and Third-Generation EGFR-TKI Oral Medication Lansizitinib Mesylate Tablets。

Amivantamab is a fully human bispecific antibody targeting EGFR and MET under development by Janssen Pharmaceuticals, part of Johnson & Johnson. In May 2021, the product received formal approval from the U.S. FDA for the treatment of patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations whose disease has progressed during or after platinum-based chemotherapy.

By Leigong

Editor｜Jiang Yun, Jia Ting

Operation｜Ying Zhu

Illustration | Visual China

Statement: Original content by Jian Shi Ju, please do not reprint without permission.

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