Four Major Inhaler Products in National Volume-Based Procurement Rebound, Led by a RMB 2B Blockbuster; Hengrui and CPQ Pharma Make the List, Qilu and Purity Pharmaceuticals Pursue First-to-File Status

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Recently, the inhalation market has seen renewed activity. On the same day, three products were approved, including Sichuan Purette Pharmaceutical's Formoterol Fumarate Inhalation Solution and Chengdu Posh Pharmaceutical's Ipratropium Bromide Inhalation Solution. So far this year, 13 varieties (78 acceptance numbers) of inhalants have been approved for marketing; to date, 18 varieties (218 specifications) have passed evaluation. Data from Menet shows that sales of inhalants in Chinese public medical institutions have exceeded 20 billion yuan in recent years, with a 1.71% year-on-year decline in the first half of 2024. Among the six national procurement varieties, four have reversed their declines. In the TOP10, inhalable Budesonide Suspension remains the "sales champion," with companies such as Hengrui Medicine and CHIATAI TIANQING making the list. There are currently 37 varieties (177 acceptance numbers) of inhalants under review for production, with companies like Qilu Pharmaceutical and Sichuan Purette Pharmaceutical striving for the first generic approvals.

Three Inhalants Approved on the Same Day, Beten, Joincare, and Renhe Yikang Lead the Approval List

Inhalants Approved for Marketing in China Since October This Year

Source: MiNeiNet China Application Progress (MED) Database

Recently, the official website of the National Medical Products Administration (NMPA) showed that the Formoterol Fumarate Inhalation Solution from Sichuan Purette Pharmaceutical, the Formoterol Fumarate Inhalation Solution from Chengdu Mizi Biopharmaceutical Technology, and the Ipratropium Bromide Inhalation Solution from Chengdu Push Pharmaceutical were approved for production on the same day under a new classification, which is considered as passing the quality evaluation. So far this year, 13 varieties (78 acceptance numbers) of inhalants have been approved for marketing in China, surpassing the total number for the whole year of 2023 (11 varieties, 64 acceptance numbers).

Inhalant Passing Situation

Source: MiNeiNet China Application Progress (MED) Database

As of now, 18 types (218 specifications) of inhalants have passed the evaluation. Among them, the most popular are inhaled acetylcysteine solution, terbutaline sulfate nebulizer solution, ipratropium bromide solution for inhalation, and salbutamol sulfate solution for inhalation, with 20 or more companies passing the evaluation for each. In terms of therapeutic categories, the largest number of approved varieties are for respiratory system medications, with 15 types (203 specifications).

Groups with 5 or More Approved Inhalants

Source: MiNeiNet China Application Progress (MED) Database

In terms of the number of approved varieties in the group, both Betta Pharmaceuticals and Joincare Pharmaceutical have 9 each, Renhe Yikang has 7, while Hunan Warner Pharmaceutical, Shandong Jingwei Pharmaceutical, and Suzhou Hongsen Pharmaceutical each have 5.

Four varieties have exclusively passed the evaluation: Desflurane for Inhalation (Hengrui Medicine), Mometasone Furoate Nasal Spray (Lek of Slovenia), Azelastine Fluticasone Nasal Spray (Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray) (Changfeng Pharmaceuticals), and Salmeterol Fluticasone Inhalation Powder (Joincare Pharmaceutical).

Four Major Centralized Procurement Products Rebound! 2 Billion Yuan Product Takes the Lead, Hengrui and CHIATAI TIANQING Make the List

Data from MiNe Network shows that in recent years, the terminal sales scale of inhalants in China's urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (referred to as Chinese public medical institutions) has exceeded 20 billion yuan. In the first half of 2024, it declined by 1.71% year-on-year. Among the top 20 groups, AstraZeneca, GlaxoSmithKline, and Hengrui Medicine ranked in the top three. Bet Pharmaceutical entered the top ten with a growth rate of over 30%. The growth rates of CTP Pharmaceutical, Renhe Yikang, and Organon Pharmaceutical all exceeded 20%. In terms of therapeutic categories, respiratory drugs dominate.

Top 10 Inhalation Products in Chinese Public Medical Institutions in the First Half of 2024

Source: MiNei Network's Competitive Landscape of Drug Terminals in Chinese Public Medical Institutions

The market concentration of inhalation products is relatively high, with the top 10 combined market share accounting for over 70%. Among them, inhalation budesonide suspension leads with sales exceeding 2 billion yuan, while sevoflurane inhalation solution, budesonide formoterol fumarate dihydrate powder inhaler (Ⅱ), and acetylcysteine inhalation solution all surpass 1 billion yuan in sales.

Sales Growth Rates of Four Rebounding Centralized Procurement Products in Chinese Public Medical Institutions in Recent Years

Source: MiNei Network's Competitive Landscape of Drug Terminals in China's Public Medical Institutions

Currently, six types of inhalants have been included in the centralized procurement, five of which are among the top 20 products. In terms of growth rate, four products from the fourth and fifth batches—Salbutamol Sulfate Inhalation Solution, Budesonide Suspension for Inhalation, Ipratropium Bromide Solution for Inhalation, and Compound Ipratropium Bromide Solution for Inhalation—have reversed their decline and rebounded, with year-on-year growth rates of 0.57%, 9.20%, 18.09%, and 4.43% respectively in the first half of 2024. Meanwhile, Terbutaline Sulfate Nebulizer Solution from the seventh batch and Levosalbutamol Hydrochloride Nebulizer Solution from the ninth batch have declined year-on-year by 30.28% and 7.94%, respectively.

Budesonide Suspension for Inhalation Maintains "Sales Champion" Position Despite the Impact of Centralized Procurement, with a Year-on-Year Growth of 9.20% in the First Half of 2024. Although AstraZeneca Holds the Largest Market Share, Its Proportion is Rapidly Declining, from Over 70% in 2021 to Less Than 40% in the First Half of 2024; Meanwhile, Four Domestic Companies That Won Bids—Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Sichuan PureTech Pharmaceutical Co., Ltd., and Changfeng Pharmaceuticals—are Quickly Expanding Their Market Shares. Currently, Eight Enterprises Possess Production Approval for Budesonide Suspension for Inhalation, Among Which Zhejiang Furuisi Pharmaceutical, Hebei Renheyikang Pharmaceutical, and Nanjing Licheng Pharmaceutical Were Approved This Year; Additionally, Ten Companies Including Lunan Better Pharmaceutical, Hunan Chunjian Pharmaceutical Technology, and Zhejiang Saimo Pharmaceutical Are Under Review for Generic Drug Category 4 Applications.

Top 10 Inhalation Brands in Chinese Public Medical Institutions in the First Half of 2024

Source: Terminal Competition Pattern of Pharmaceutical Products in Chinese Public Medical Institutions (MiNe Network)

Among the top 10 brands, AstraZeneca's Budesonide/Formoterol Fumarate Powder for Inhalation (Ⅱ) and Budesonide Suspension for Inhalation, as well as Shanghai Hengrui Medicine's Sevoflurane for Inhalation ranked in the top three. AstraZeneca's Budesonide/Formoterol Fumarate Powder for Inhalation (Ⅱ) is the only brand with sales exceeding 1 billion yuan.

In terms of growth rate, four brands showed positive growth, with Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'s inhalable budesonide suspension demonstrating the fastest growth, exceeding 50%. In terms of the number of brand listings, AstraZeneca has three products on the list, followed by JoinCare Pharmaceutical Group with two products.

A Surge of New Inhalants: Qilu, Prd (Pulmicort)…Race for the First Generic

On November 13, the ipratropium bromide inhalation aerosol from Sichuan Puerite Pharmaceutical, the formoterol fumarate inhalation solution from Jiangsu Dahongying Hengshun Pharmaceutical, and the tiotropium bromide inhalation powder from Suzhou Omnia Pharmaceuticals were all accepted by the CDE for production as Category 4 generics on the same day.

As of now, there are 37 varieties (177 acceptance numbers) of inhalants under production review. The most sought-after is Formoterol Fumarate Inhalation Solution, with 21 companies involved. Four products—Acetylcysteine Inhalation Solution, Procaterol Hydrochloride Inhalation Solution, Levalbuterol Hydrochloride Nebulizer Inhalation Solution, and Budesonide Inhalation Suspension—have 10 or more companies reporting production under review. In terms of the number of companies, Sichuan Puregon Pharmaceutical, Hulusa Pharmaceutical, and Conba each have four varieties under production review. Hainan Star Pharmaceutical, Shanxi Dayin Children's Pharmaceutical, Shijiazhuang No. 4 Pharmaceutical, and others each have three varieties under production review.

Inhalants Without Generic Drugs Approved and Under Review in China

Source: MiNeiNet China Application Progress (MED) Database

In addition, there are currently no generic versions of fluticasone propionate nasal spray, budesonide/formoterol inhalation aerosol, bromhexine hydrochloride inhalation solution, and beclomethasone dipropionate inhalation suspension approved in China. Companies such as Qilu Pharmaceutical, Sichuan Puruide Pharmaceutical, and Beijing Shuanglu Pharmaceutical are expected to obtain the first generic approvals.

Source: NMPA official website, MiNeiNet database, etc.

Note: The terminal sales pattern of pharmaceuticals in Chinese public medical institutions by MiNe Network covers the following areas: urban public hospitals, county-level public hospitals, urban community health centers, and township health centers, excluding private hospitals, private clinics, and village health stations; the sales figures are calculated based on the average retail price of products at the point of sale. Any corrections or omissions are welcome!