Five Antineoplastic Drugs Prepare for China's 10th National Volume-Based Procurement Round, Involving CSPC, Kelun, and Qilu

　　【Pharmaceutical Network Industry Dynamics] Driven by policies such as centralized procurement and medical insurance negotiations, the anti-tumor drug market (chemical drugs + biologics, hereinafter the same) has experienced ups and downs. Data shows that in the first half of 2023, the sales scale of anti-tumor drugs in Chinese public medical institutions exceeded 58 billion yuan.
 

According to reports, on January 9, 2024, the National Healthcare Security Conference was held in Beijing. In addition to summarizing the healthcare security work of 2023, it also made arrangements for the healthcare security work of 2024. Among the points, the sixth point of the 2024 healthcare security work mentioned promoting the "expansion and quality improvement" of centralized procurement. Specifically, "new rounds of national-level centralized procurement of medicines and consumables will be carried out, ensuring the renewal of agreements for selected products upon expiration, achieving a total of at least 500 types of medicines through national and provincial-level procurement." From this perspective, the tenth batch of national procurement may be about to start.
 

In the field of anti-tumor drugs, excluding those already included in the national centralized procurement, there are currently five varieties meeting the procurement threshold, with five or more companies eligible to apply. These include three injectables and two oral immediate-release formulations. CSPC, Kelun, Qilu Pharmaceutical, Hansoh, CTP Pharmaceutical, Aosaikang, and Fosun, among others, have multiple products listed.
 

These five varieties are fluorouracil injection, doxorubicin hydrochloride liposome injection, palbociclib capsules, nintedanib ethanesulfonate soft capsules, and dexrazoxane for injection. Data shows that the total sales scale of these five varieties in Chinese public medical institutions in 2022 was nearly 7 billion yuan.
 

According to the data, fluorouracil injection has a broad anti-tumor spectrum and is mainly used for the treatment of digestive tract tumors. Higher doses of fluorouracil are also used to treat choriocarcinoma. It is commonly used for breast cancer, ovarian cancer, lung cancer, cervical cancer, bladder cancer, and skin cancer, among others. Statistics show that the sales of fluorouracil injection in Chinese public medical institutions exceeded 1.2 billion yuan in 2022. Currently, companies that have received approval for this product include Tianjin Jinyao Pharmaceutical, Shanghai Xudong Haipu Pharmaceutical, Sichuan Huiyu Pharmaceutical, Shijiazhuang Rongwu Di Pharmaceutical, and Shandong Beida Huatai Pharmaceutical.
 

Liposomal Doxorubicin Hydrochloride Injection is a new formulation of doxorubicin encapsulated using advanced stealth liposome technology, possessing passive targeting properties. As an updated anthracycline drug, it offers advantages in oncology treatment such as enhanced efficacy, reduced cardiotoxicity, less bone marrow suppression, and decreased hair loss. Data shows that the sales of Liposomal Doxorubicin Hydrochloride Injection in Chinese public medical institutions exceeded 4.6 billion yuan in 2022. Companies that have passed the quality evaluation include Fudan-Zhangjiang Bio-Pharmaceutical, CSPC Ouyi Pharmaceutical, Changzhou Jinyuan Pharmaceutical, Zhejiang Zhida Pharmaceutical, and Zhejiang Shengzhao Pharmaceutical Technology.
 

Palbociclib is a cyclin-dependent kinase (CDK) 4/6 inhibitor, suitable for the treatment of postmenopausal women with advanced breast cancer that is estrogen receptor (HR) positive and human epidermal growth factor receptor (HER2) negative. Currently, the companies that have received approval for this product include Kelun Pharmaceutical, Yaoyou Pharmaceutical, Qilu Pharmaceutical, Aishite Pharmaceutical, Hansoh Pharmaceutical, Shanxi Xiang Medicine, Taiding Pharmaceutical, Zhengdatianqing, Zeyun Biomedical, Chuangnuo Pharmaceutical, and Aosaikang Pharmaceutical.
 

Nintedanib ethanesulfonate soft capsules, developed by Boehringer Ingelheim, are a multi-target tyrosine kinase inhibitor (TKI) and a targeted drug globally approved for the treatment of idiopathic pulmonary fibrosis (IPF). The companies that have received approval for this product include Humanwell Pfizer Pharmaceuticals, CSPC Enbipu Pharmaceutical, Hansoh Pharmaceutical, Kelun, and Qilu Pharmaceutical. Data shows that in 2022, the sales revenue of nintedanib ethanesulfonate soft capsules in China's urban, county-level, and township public hospitals as well as urban physical pharmacies was approximately RMB 450 million.
 

Dexrazoxane, the d-isomer of razoxane, can rapidly penetrate cell membranes and reduce the cardiotoxicity of anthracycline antitumor antibiotics such as doxorubicin. It is currently the clinically recognized drug for preventing anthracycline-induced cardiotoxicity and was originally developed by Chiron Corporation in the United States. The product has been approved by several pharmaceutical companies, including Aosaikang Pharmaceutical, Zhongrun Pharmaceutical, Yangtze River Pharmaceutical, Hairun Pharmaceutical, Gland, and Zhengdatianqing.
 

From the perspective of companies with approved products, CSPC, Kelun, Qilu Pharmaceutical, Hansoh Pharmaceutical, C.C. Pharm, Aosaikang, and Fosun Pharma each have two products on the list. Yangtze River Pharmaceutical, Renfu Pharmaceutical, and Sichuan Huiyu Pharmaceutical also have products involved.
 

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