Latest Updates on National High-Value Medical Consumables Centralized Procurement, Six Individuals Disciplined This Week, and Rising Rejections of New Drug Applications

In September, the pharmaceutical sector resumed its normal work pace, with multiple medical conferences restarting. However, the intense momentum of the anti-corruption campaign has not subsided, and according to incomplete statistics,Six People in the Medical Field Investigated or Disciplined This Week。

With the arrival of the third quarter, the centralized procurement process has entered a critical phase, and completing the annual volume-based procurement tasks as soon as possible has become one of the main goals for many provinces. Several alliances and regions have successively announced news of carrying out centralized procurement, including the Beijing-Tianjin-Hebei "3+N" Alliance Volume-linked Procurement and the Shandong-led Traditional Chinese Medicine Formula Granules Alliance Centralized Procurement.

More information is organized by Jian Shi Ju as follows.

1. New Progress in China's Fourth Batch of Medical Consumables Centralized Procurement

According to media reports, on September 7,The Joint Procurement Office for High-Value Medical Consumables of the National Organization ("Joint Procurement Office") issued a document notifying all member units to convene a meeting.The meeting content includes the introduction of the follow-up work arrangements for the fourth batch of national organization's centralized volume procurement of medical consumables, and the deployment of medical institutions' volume reporting, etc.

The documents show that the fourth batch of high-value consumables for national procurement involves artificial crystals and high-value orthopedic sports medicine consumables.

According to the disclosure on the official website of Tianjin Municipal Medical Insurance Bureau, from August 29 to 30, Shi Zihai, member of the Party Leadership Group and Deputy Director of the National Healthcare Security Administration, led a team to Tianjin for research. They visited the Tianjin Medical Products Procurement Center, which is the Joint Procurement Office for high-value medical consumables organized by the state, emphasizing the need to accelerate the advancement of the fourth round of national centralized procurement of high-value medical consumables. The Tianjin Municipal Medical Insurance Bureau stated that it will summarize experiences, make continued efforts, and expedite all preparatory work before the implementation of the fourth round of national centralized procurement of high-value medical consumables to ensure the project starts on schedule. Meanwhile, they will actively promote the research and investigation of high-value medical consumable products.Research and Determine the Proposed Categories for the 2024 High-Value Medical Consumables Centralized Procurement as Early as Possible。

2. Publication of Joint Procurement Varieties in the "3+N" Alliance in the Beijing-Tianjin-Hebei Region

Recently, the Tianjin Medical Procurement Center released the "Notice on Carrying Out the Volume-Based Joint Procurement of Some Western Medicines and Traditional Chinese Medicines in the Beijing-Tianjin-Hebei '3+N' Alliance."A total of three batches and 200 drugs included in the volume-based linkage scope。(Reply "Joint List" to get the list)

According to the rules, the enterprise's quotation must not exceed the lowest price among the selected prices in all provincial (including provincial and inter-provincial) centralized procurement in China for the product, as well as the lowest price of actual purchases that occurred in the alliance regions in the past year. For products that have never been selected, the quotation must not exceed the highest price among the lowest selected prices of all previously selected products of the same type, as well as the lowest price of actual purchases that occurred in the alliance regions in the past year.

Currently, 11 provinces have issued notifications for volume reporting, and several other provinces are basically confirmed to participate. The influence of this alliance procurement cannot be underestimated.

3. Publication of the First Batch of DRG-linked Volume-based Procurement Results in Beijing

On September 5, the Beijing Municipal Medical Insurance Bureau released the "Notice on Announcing the Winning Results of the First Batch of DRG Payment and Volume-Based Procurement Linked Management Products." This linked procurement was led by a procurement group consisting of six top-tier tertiary hospitals in Beijing, focusing on high-value medical consumables in the fields of sports medicine, neurointervention, and electrophysiology.

From the results of the selection, the overall price reduction is moderate. Among them, the selected products in the neurointerventional coil category include both domestically produced and imported products, with prices ranging from 3,277 yuan to 8,133 yuan; all bare stents for aneurysms are imported products, with selected prices ranging from 18,900 yuan to 32,873 yuan.Intracranial stent-covered stents with only price negotiation and no volume, the selected price is 100,725 yuan.; The price of flow-diverting stent products is the highest, with the selected prices concentrated in two tiers: 116,876 yuan and 132,459 yuan.

The document for this volume-based procurement stipulates that the payment standard for disease groups will not be reduced in the first year due to product price cuts, and the surplus will belong to the hospital.

1. Six more people were investigated or disciplined this week.

According to incomplete statistics, six people in the medical field were investigated or disciplined this week.

On September 4, according to the Guizhou Discipline Inspection and Supervision Network,Zhao Fan, former Party Secretary and Director of the Health and Family Planning Bureau of the Baili Azalea Management Zone in GuizhouSuspected of serious disciplinary violations and illegal activities, currently under disciplinary review and supervision investigation.

On the same day, according to the Qingfeng Fuzhou WeChat Official Account,Liu Jianzhong, Former President of the People's Hospital Affiliated to Fujian University of Traditional Chinese MedicineSuspected of serious official misconduct, and after being designated by the Fujian Provincial Supervisory Commission, the Fuzhou Municipal Supervisory Commission has initiated an investigation.

On September 5, according to the Lipu Discipline Inspection and Supervision WeChat Official Account, recently, the Lipu City Commission for Discipline Inspection and Supervision...Huang Yaowen, Former President of Lipu Hospital of Traditional Chinese MedicineInvestigated and reviewed the suspected serious disciplinary violations and illegal issues, and imposed detention measures on him. After investigation of serious disciplinary violations and illegal activities, it was decided to expel Huang Yaowen from the party membership by the Lipo City Supervisory Committee, and to dismiss him from public office; confiscate his illegal gains; transfer his suspected criminal issues to the procuratorial organs for legal review and prosecution.

On September 7, according to the Anhui Discipline Inspection and Supervision Network,Cao Huazhi, former Party Secretary and Director of the Health Bureau of Fuyang CitySuspected of serious disciplinary violations and illegal activities, voluntarily surrendered, currently under disciplinary review by the Fuyang Municipal Commission for Discipline Inspection and Supervision Commission investigation.Xia Xiaojian, Director of the Publicity and United Front Department of Ma'anshan Traditional Chinese Medicine HospitalSuspected of serious disciplinary violations and illegal activities, under the jurisdiction designated by the Ma'anshan Commission for Discipline Inspection and Supervisory Committee, currently undergoing disciplinary review and supervisory investigation by the Bowang District Commission for Discipline Inspection and Supervisory Committee of Ma'anshan City.

On September 8, according to the Qingfeng Luling WeChat Official Account of the Ji'an Municipal Commission for Discipline Inspection and Supervision, recently, with the approval of the Communist Party of China Taihe County Committee, the Taihe County Commission for Discipline Inspection and Supervision conducted an investigation.Mao Faming, the Former Party Secretary of Taihe County People's HospitalSerious disciplinary and legal violations were investigated through disciplinary review and supervision investigation. It was found that the individual had committed serious disciplinary and legal violations, resulting in expulsion from the Party and dismissal from public office.

2.2022: The Number of New Drug Registration Applications Rejected Increased by 25%

On September 7, the CDE released the "2022 Drug Evaluation Report," revealing several new trends in drug evaluation.

One is the decrease in the number of new drug registration clinical trials. In 2022, the Drug Clinical Trial Registration and Information Disclosure Platform recorded a total of more than 3,410 clinical trials, the highest number of registrations in history. However, the number of new drugs was 1,974, accounting for 57.9%.The number of cases decreased compared to 2021.In 2021, there were a total of 2,033 clinical trial registrations for new drugs, accounting for 60.5%.

The second is the improvement in the efficiency of clinical trial implementation. In 2022, the proportion of new drug clinical trials that could initiate participant recruitment within 6 months further increased, accounting for 55.8%. The time was further shortened compared to 2021, with an average of 3.3 months.

The third isIncrease in New Drug Registration Application RejectionsIn 2022, there were a total of 228 new drug registration applications that, due to the submission materials being unable to demonstrate their safety, efficacy, or quality controllability, received a review conclusion of non-approval/recommendation for non-approval after technical evaluation, marking a year-on-year increase of 24.59%.

3. Novartis "Global No. 2 Figure" Resigns

On September 6, Novartis announced on its official website:President and Chief Commercial Officer of International Innovative Drug Division, Chu Muli, Decides to Leave the Company, and will step down from the Novartis Executive Committee, with the last working day on September 15.

Patrick Horber, M.D., Senior Vice President and President of Immunology at AbbVie, will join Novartis as President of Novartis International. Patrick Horber will report directly to Vas Narasimhan, M.D., Chief Executive Officer of Novartis.

According to foreign media reports, with this personnel change, Novartis has also eliminated the title of Chief Commercial Officer. In April last year, as part of a company-wide restructuring, Novartis introduced its current organizational structure and operating model, integrating the pharmaceuticals and oncology divisions into a unified Innovative Medicines Division. The company is now divided by geography rather than therapeutic area, splitting globally into two independent commercial regions—the United States and International—operating independently, with separate accounting and full responsibility for all therapeutic areas. Additionally, the strategy, R&D portfolio strategy, and business development departments were merged into a unified Strategy and Growth function.

1. CSPC's Narusoban Antibody Approved for Marketing

On September 6, the official website of the National Medical Products Administration (NMPA) showed,CSPC's Subsidiary Shanghai GeneMab Biological Technology Co., Ltd.'s New Drug Narusobimab Injection Granted Conditional Approval for Market Launch via Priority Review and Approval Process, for the treatment of adult patients with giant cell tumor of bone who are not candidates for surgical resection or whose surgical resection may lead to severe functional impairment. Commercial name: Jin Li Sheng.

Narulizumab is the world's first approved IgG4 subtype fully human anti-RANKL monoclonal antibody. Currently, the marketed drug with the same target, denosumab, is of the IgG2 subtype. Compared with denosumab, narulizumab has significantly improved uniformity and quality controllability.

Clinical trial data show that narusobamab has better clinical efficacy in the treatment of unresectable or surgically difficult giant cell tumor of bone, with a tumor response rate as high as 93.3%, presenting a trend higher than that of the denosumab group. Meanwhile, the safety risk is controllable. Other indications under development for narusobamab also include bone metastasis of tumors and osteoporosis, etc.

Source: Official website of the National Medical Products Administration

2. Beijing Tiantan Biological Products Corporation Limited's Recombinant Factor VIII Approved for Marketing

On September 8, the official website of the National Medical Products Administration (NMPA) announced,Beijing Tiantan Biological Products Corporation Limited's Subsidiary, Chengdu Ronsen Pharmaceutical Co., Ltd., Receives Approval for Recombinant Factor VIII for Injection to Treat Hemophilia A Patients。

Hemophilia A is a bleeding disorder caused by a deficiency of clotting factor VIII. If repeated bleeding episodes are not treated promptly, they can lead to joint deformities and/or pseudo-tumor formation, and in severe cases, may be life-threatening. The primary treatment method currently available is clotting factor VIII replacement therapy, which includes human clotting factor and recombinant human clotting factor.

A phase 3 multicenter clinical trial for prophylactic treatment in pediatric patients with severe hemophilia A who have undergone treatment is currently underway.

3. New Anticancer Drug Mitotane Tablets Approved for Marketing

On September 8, the official website of the National Medical Products Administration (NMPA) announced,HRA Pharma Rare Diseases' Mitotane Tablets Have Been Approved for Marketing in ChinaAccording to the priority review announcement, the indication approved this time for the drug is adrenocortical carcinoma (ACC).

Adrenocortical carcinoma is a rare and aggressive cancer. Mitotane, an adrenocorticolytic agent, inhibits the adrenal cortex from producing corticosteroid hormones. Previously, mitotane has been approved in multiple countries and regions, including Europe, the United States, and Canada.

Public information shows that HRA has appointed Jiedi Pharmaceutical Technology (Shanghai) Co., Ltd. as the exclusive authorized agent for Mitotane in the Greater China region, responsible for drug registration, medical insurance applications, and other related work in mainland China, Hong Kong, Macao, and Taiwan.

Author: Li Ao

Editor | Jiang Yun, Jia Ting

Operation | Zhu Ying

Image source: Visual China

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