Ninth Round of National Drug Procurement Sees 21 Products' Competitive Landscape Shift as Kelun, Qilu, and Yuandong Secure Last-Minute Qualifications

The ninth batch of national procurement will be opened for bidding on November 6. According to the procurement documents of the ninth batch of national procurement, reference preparations and approved drugs (including those deemed as approved) that obtained approval before October 30 (inclusive) can be declared. Enterprises should complete the information declaration for their declared products by 17:00 on November 2, 2023.

 

Recently, an increasing number of drug varieties have "barely" passed evaluations to secure a spot in the ninth round of centralized procurement. Compared to when the official document was released, the competitive landscape for 21 varieties has changed, with new companies passing evaluations or being considered as having passed by October 30 (inclusive). The number of varieties meeting the eligibility criteria for ≥10 companies has increased by seven to 20, with three major injectables becoming highly sought-after. Companies like Kelun, Qilu Pharmaceutical, China National Pharmaceutical Group (Sinopharm), China Resources Double-Crane, China Resources Tianjin Pharmaceutical, and Chengdu Easton Bio Pharmaceuticals have had new varieties pass evaluations. Among them, China Resources Tianjin Pharmaceutical added three new varieties, while Huaxia Shengsheng Pharmaceutical (Beijing), Shandong Qidu Pharmaceutical, and Shandong Langnuo Pharmaceutical each added two.

 

Varieties with New Enterprises Passing the Evaluation in the Ninth Batch of Centralized Procurement

Note: Sales volume is not divided by specifications, and values below 100 million yuan are represented by *; the highest procurement amount is calculated based on the first-year agreed procurement volume multiplied by the highest valid bid price; companies that have passed the evaluation include marketing authorization holders, etc.

 

　　01、Seven New Additions, Twenty Products in Fierce Competition

 

According to the statistics of the review conclusion date, compared with the official document release date (October 13), the number of varieties in the ninth batch of centralized procurement that meet the eligibility criteria for declaration increased by 7 to 20. These include Urapidil Injection, Dopamine Injection, Atropine Injection, Cytidine Diphosphate Choline (Citicoline) Injection, Glycerol Fructose Sodium Chloride Injection, Sildenafil Citrate Orally Disintegrating Tablets, and Piracetam Injection.

 

Varieties with ≥10 eligible companies (counted by group)

 

Note: Marked in red indicates newly added approved enterprises.

 

Citicoline (Cytidine Diphosphate Choline) injection has the highest number of newly qualified enterprises, reaching six: Suzhou Tairui Pharmaceutical, Hubei Jinyao Pharmaceutical, Huaxia Shengsheng Pharmaceutical (Beijing) Co., Ltd., Shandong Hualu Pharmaceutical, Yabao Pharmaceutical, and Guangdong Dingxin Pharmaceutical. The number of enterprises meeting the application requirements increased from 9 to 15, and the maximum number of shortlisted enterprises increased from 7 to 10. As a nucleoside derivative, citicoline improves cerebral circulation and promotes the recovery of brain function. In 2022, it was widely used in urban public hospitals in China.HospitalThe sales revenue at the terminals of county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) exceeds 600 million yuan. Zhongjia Bio (not yet evaluated) leads with over 30% market share, followed closely by Shandong Hualu Pharmaceutical (already evaluated) and Guangdong Dingxin Pharmaceutical (already evaluated).

 

Top 5 Manufacturers of Cytidine Diphosphate Choline (CDP-Choline) Injection in Chinese Public Medical Institutions, 2022

 

The number of newly qualified enterprises for Urapidil injections ranks second, reaching five: Hangzhou Yunbai Pharmaceutical, Chengdu Lier Pharmaceutical, Huaxia Shengsheng Pharmaceutical (Beijing) Co., Ltd., Heilongjiang Fuhe Pharmaceutical, and Shaanxi Licai Pharmaceutical. The number of enterprises meeting the application requirements increased from 8 to 13, while the maximum number of shortlisted enterprises rose from 6 to 10. Urapidil is a selective α1 receptor blocker with dual peripheral and central antihypertensive effects. In 2022, its sales revenue in Chinese public medical institutions reached nearly 1.5 billion yuan, making it the best-selling antihypertensive drug.HypertensionInjectables. In terms of the manufacturer landscape, Takeda holds nearly 50% of the market share, while Luoxin Pharmaceutical (already approved) and Xi'an Lijun Pharmaceutical (already approved) each account for over 10%.

 

Top 5 Manufacturers of Urapidil Injection in Chinese Public Medical Institutions, 2022

 

Dopamine Injection Adds 4 New Qualified Companies: Anhui Changjiang Pharmaceutical, Beijing Fukanren Bio, Chengdu Easton Bio Pharmaceuticals, and Guangdong Saifeng Pharmaceutical. The number of companies meeting the application qualifications has increased from 8 to 12, and the maximum number of shortlisted companies has increased from 6 to 9. This is an adrenergic receptor agonist that can correct shock and, in this round of procurement, reached its highestProcurementThe amount (purchase base * highest valid bid price, the same below) exceeds 400 million yuan, with companies such as Shanghai Hefeng Pharmaceutical, Jilin Jinseng Pharmaceutical, and Hefei Weilai Drug Development dominating the market.

 

2022 China Public Medical Institution Terminal Dopamine Injection Manufacturer Landscape

 

Atomoxetine Hydrochloride Oral Solution was the most competitive variety in this centralized procurement. It is a selective norepinephrine reuptake inhibitor used to treat attention deficit/hyperactivity disorder in children and adolescents. Originally, 17 companies met the eligibility criteria, with a maximum of 10 companies allowed to qualify. After two additional companies joined, the maximum number of qualifiers remained unchanged, intensifying competition further. Due to its relatively late market entry, the Atomoxetine Hydrochloride Oral Solution market has not yet seen rapid growth. Most of the companies participating in the bidding are new entrants, who may leverage the volume-based procurement to quickly capture market share.

 

Oxytocin Injection, a peptide hormone uterine contractile agent, can be used for labor induction or augmentation, and control of postpartum hemorrhage. In this round of centralized procurement, the maximum procurement amount exceeded 1.3 billion yuan, with 13 domestic companies securing their "tickets" to participate, three more than when the official document was released. In the 2022 landscape of oxytocin injection manufacturers in China's public medical institutions, Nanjing Xinbai Pharmaceutical (already evaluated) dominated the market with approximately 45% market share, while Shanghai Hefeng Pharmaceutical (already evaluated), Anhui Hongye Pharmaceutical (not yet evaluated), and Chengdu Haitong Pharmaceutical (already evaluated) each held over 10% of the market share.

 

　　02、Kelun、Qilu、Easton、Tianjin Pharmaceutical...... "Last-Minute" Entry

 

Compared with the time of the official document release, Kelun, Qilu Pharmaceutical, Sinopharm Group, and China ResourcesPharmaceuticals, China Resources Tianjin Pharmaceutical, Jincheng Pharmaceutical, Chengdu Easton Bio Pharmaceuticals, Huanghai Pharmaceutical, Shandong Langnuo Pharmaceutical, Shandong Qidu Pharmaceutical, etc.EnterpriseNewly Added Approved Varieties.

 

The number of enterprises (counted by group, the same below) with ≥4 approved varieties increased by 5, including Tianjin Pharmaceutical, Chengdu Easton Bio Pharmaceuticals, Hainan Huanglong Pharmaceutical, Jiangsu Hengrui Medicine, and Huaxia Shengsheng Pharmaceutical. Additionally, among the TOP10 enterprises, China Resources Pharmaceutical, Sinopharm Group, Kelun, and Qilu Pharmaceutical each added one newly approved variety, namely rabeprazole oral conventional release formulation, atropine injection, magnesium sulfate injection, and sildenafil citrate orally disintegrating tablets, respectively.

 

Enterprises with ≥4 approved varieties

 

China Resources Pharmaceutical has newly passed the evaluation for one variety, ranking as the top enterprise with nine varieties passing the evaluation. According to the 2022 competitive landscape of terminal sales in China's public medical institutions, China Resources Pharmaceutical holds a 0% market share in varieties such as Silodosin Oral Immediate-Release Formulations, Lacosamide Oral Liquid, Olmesartan Medoxomil Hydrochlorothiazide Oral Immediate-Release Formulations, Olmesartan Medoxomil Amlodipine Oral Immediate-Release Formulations, and Omeprazole Sodium Bicarbonate Oral Immediate-Release Formulations, indicating that the market still needs to be developed.

 

China Resources Pharmaceutical Ninth Batch Centralized Procurement Products

 

Tianjin Pharmaceutical Passes Evaluation for 3 New Injectable Agents: Citicoline (Cytidine Diphosphate Choline) Injection, Magnesium Sulfate Injection, and Piracetam Injection. The number of products included in the 9th batch procurement has increased from 2 to 5. According to the competitive landscape of China’s public medical institution terminals in 2022, Tianjin Pharmaceutical holds a relatively low market share in products such as Piracetam Injection and Citicoline (Cytidine Diphosphate Choline) Injection, indicating that the market still has room for growth.

 

Tianjin Pharmaceutical Ninth Batch Centralized Procurement List

 

Kelun Pharmaceutical has newly passed the evaluation for one variety, the injectable form of magnesium sulfate. In 2022, its shares in varieties such as levalbuterol hydrochloride nebulizer solution, injectable form of calcium gluconate, and injectable form of citicoline (cytidine diphosphate choline) were all 0%. Among them, the highest procurement amount for the injectable form of calcium gluconate exceeded 800 million yuan.

 

Kelun's Ninth Batch of Centralized Procurement Products

 

Chengdu Easton Bio Pharmaceuticals Co., Ltd. has newly passed the evaluation for one variety, increasing the number of varieties included in the ninth batch of centralized procurement to four (three of which are oral liquid formulations). Its market share for these four varieties in 2022 was 0%, and it is expected to achieve rapid volume growth through winning the centralized procurement bid.

 

The 9th Batch of Centralized Procurement Products by Chengdu Easton Bio Pharmaceuticals Co., Ltd.

 

The Competitive Landscape of 42 Varieties in the 9th Batch of Centralized Procurement

 

Source: MNI Database, Shanghai Sunshine Pharmaceutical Procurement Network, etc.; Data statistics as of October 31. Any omissions are welcome to be corrected.