23 Domestic Innovative Drugs Included in China's 2023 National Reimbursement Drug List, Featuring Qilu Pharma, Hengrui Medicine, and Betta Pharma

On December 13, the National Healthcare Security Administration (NHSA) announced the adjustment results of the 2023 National Reimbursement Drug List (NRDL). Ultimately, 126 drugs were newly included, while one drug was removed due to its upcoming withdrawal from the market. A total of 143 off-list drugs participated in negotiations or bidding, with 121 successfully passing, achieving a success rate of 84.6% and an average price reduction of 61.7%. The NHSA stated that the 2023 NRDL will officially take effect on January 1, 2024. Considering negotiation-based price cuts and medical insurance reimbursement, this adjustment is expected to reduce patients' financial burden by over 40 billion yuan in the next two years.

 

　　01、Average price reduction of 61.7% 126 new drugs added, 1 drug removed

 

On December 13, the National Healthcare Security Administration officially released the 2023 edition of the National Healthcare Security...MedicineList of Catalog Adjustments.

 

According to statistics, the 2023 National Medical Insurance Drug Catalog added 126 drugs (including 5 directly transferred drugs), including 21 anti-tumor drugs, 17 COVID-19 treatment and anti-infective drugs, 15 chronic disease drugs for diabetes, mental illness, rheumatism and immunology, 15 rare disease drugs (of which Avapritinib Tablets are also anti-tumor drugs), and 59 other drugs in various fields. At the same time, one drug that is about to be withdrawn from the market (Elbasvir and Grazoprevir Tablets) has been removed.

 

143 off-list drugs participated in the negotiation and bidding, of which 121 succeeded, with a success rate of 84.6%. The average price reduction was 61.7%, with both the success rate and price reduction being roughly equivalent to those in 2022. Considering the combined effects of negotiated price reductions and medical insurance reimbursement, it is estimated that patients will save over 40 billion yuan in the next two years.

 

After this round of adjustments, the total number of drugs in the National Medical Insurance Drug Catalog has reached 3,088, including 1,698 Western medicines and 1,390 traditional Chinese patent medicines. The number of traditional Chinese medicinal slices remains unchanged at 892.

 

Overview of National Medical Insurance Drug Negotiations from 2016 to 2023
　　

Source: National Healthcare Security Administration, National Human Resources and Social Security Department, etc., compiled by Menet

 

From 2016 to the present, China's national medical insurance negotiations have been carried out in eight rounds, continuously optimizing the structure and efficacy of drugs in the directory, gradually addressing gaps in coverage for cancer drugs, chronic disease medications, rare disease treatments, and pediatric medicines. Compared with previous years, the 2023 national negotiations have seen a qualitative leap in the number of newly added varieties and negotiation success rates.

 

In recent years, the National Medical Insurance Catalog has been adjusted on an "annual basis." Over 80% of new drugs can be included in the insurance within two years of their market launch, covering clinical treatment areas such as COVID-19 infection, cancer, chronic diseases, rare diseases, and pediatrics. A large number of new mechanism and new target drugs have been incorporated into the catalog, continuously optimizing the structure of medical insurance medicines and further improving the level of public medication security.

 

　　02、Domestically Produced New Drug、Rare Disease Drugs Spark Another Wave of Enthusiasm Qilu、Betta Pharmaceuticals、AZ Successfully Breaks Through

 

In the recently announced 2023 National Reimbursement Drug List, 126 new drugs have been added. Notably, domestic pharmaceutical companies such as Kelun Pharmaceutical, Qilu Pharmaceutical, Zhengda Pharmaceutical, and Yangtze River Pharmaceutical performed impressively, each successfully including more than five products. On the import side, AstraZeneca, Roche, and Pfizer also achieved satisfactory results, with each having more than three products included.

 

Similar to last year, the state continues to increase its倾斜和支持 for innovative drugs, better addressing保障短板 in key areas such as rare diseases, and achieving a higher level and more sustainable "basic保障." On this basis, domestically produced Class 1 new drugs and rare disease medications are clearly the focal points of this round of national negotiations.

 

Newly Added Class 1 New Drugs Produced in China to the 2023 National Medical Insurance Catalog

 

Twenty-eight domestically produced Class 1 new drugs passed the 2023 national negotiation format review, with 23 drugs gaining access through negotiation/competitive bidding, achieving an access success rate of over 82%. This includes 16 chemical drugs, 4 traditional Chinese medicines, and 3 biologics.

 

Betta Pharmaceuticals has two Class 1 new drugs included for the first time, namely the third-generation EGFR-TKI inhibitor Befotertinib Mesylate Capsules and the multi-target receptor tyrosine kinase inhibitor Vorolanib Tablets. Both belong to protein kinase inhibitors and were recognized in China's urban public hospitals in 2022.HospitalThe sales scale of this category in county-level public hospitals, urban community centers, and township health centers (referred to as Chinese public medical institutions) has exceeded 29 billion yuan.

 

In addition, Qilu Pharmaceutical's Iruplakib is the first domestically produced ALK/ROS1 inhibitor; CarepharPharmaceuticalsJiangsu Carephar Pharmaceutical Co., Ltd.'s Kepulacin Hydrochloride Tablets are the first domestically developed potassium-competitive acid blocker (P-CAB) in China; Guangdong Zhongsheng Pharmaceutical Co., Ltd.'s Ravidasvir Tablets are the world’s first peptide-like 3CL COVID-19 treatment drug that does not require co-administration with Ritonavir; Humanwell Healthcare Group Co. Ltd.'s Desmodium Total Flavonoids Capsules are the world's first innovative traditional Chinese medicine for preventing and treating urolithiasis; Guang Dong Yili Pharmaceutical Group Co., Ltd.'s Huzhen Qingfeng Capsules are the first domestic Class 1 new traditional Chinese medicine for treating gout; Zhejiang Borui Biopharmaceutical Co., Ltd.'s Zebestumab Injection is the first domestically produced Class 1 new CD20 antibody drug; Yifan Pharmaceutical Co., Ltd.'s Ebagstim-alpha Injection is the world's first third-generation dual-molecule leukocyte booster; Jiangsu Hansoh Pharmaceutical Group Co., Ltd.'s Pemostatin Injection is the world’s only highly specific small peptide agonist of the EPO receptor.

 

Newly Added Rare Disease Drugs in the 2023 Medical Insurance Catalog

 

In terms of rare disease drugs, 25 drugs passed the previous national negotiation format review, and 15 drugs were newly included in the medical insurance, covering 16 types of rare diseases, filling the medication security gaps for 10 disease types.

 

Among them is Miglustat Tartaric Acid Capsules, used for the treatment of Gaucher's disease. The original product has not yet been approved for import, but Carephar Pharmaceutical's first generic version was approved for marketing in October 2022 and was the first to pass the quality evaluation. According to the latest national medical insurance directory, the product is covered by medical insurance.StandardAt 381.00 yuan (84mg/capsule), compared to the high bid price of Takeda's similar product, Velaglucerase Alfa for Injection (which "narrowly missed" inclusion in the medical insurance catalog for the third time) at 11,380 yuan (4.4ml/vial), its smooth entry into the catalog will further improve the drug accessibility for patients with this type of rare disease.

 

In addition, the rare disease drugs newly added to the medical insurance catalog include: AstraZeneca's eculizumab injection for the treatment of paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and refractory generalized myasthenia gravis positive for anti-acetylcholine receptor antibodies, as well as selumetinib sulfate capsules for neurofibromatosis type I; Boehringer Ingelheim's pemziviptadil injection for the treatment of generalized pustular psoriasis in adults; BMS's ozanimod hydrochloride capsules for the treatment of relapsing multiple sclerosis in adults; Argenx's efgartigimod alfa injection for the treatment of generalized myasthenia gravis in adults; Roche's drug for neuromyelitis optica spectrum disorders.

 

(NMOSD) treatment drugs such as Satralizumab, etc.

 

It is estimated that the inclusion of the above 15 rare disease drugs in the directory will potentially benefit nearly 10,000 patients.

 

　　03、Another 5 national procurement products directly transferred in 16 Non-Exclusive Products Compete for "Inclusion in Insurance"

 

Since the adjustment of the 2022 National Medical Insurance Drug List, "competitive bidding for non-exclusive drugs" has become a new highlight. Reviewing the additions to the 2022 edition, three non-exclusive products—Memantine Hydrochloride Extended-Release Capsules, Edaravone Injection, and Temozolomide for Injection—were directly included in the regular list. These three products have been incorporated into the seventh batch of national procurement. Additionally, 17 other non-exclusive products entered the list through competitive bidding.

 

Latest Updates on the 2023 Edition: Four non-exclusive products—Esomeprazole Magnesium Enteric-Coated Dry Suspension, Lacosamide Oral Solution, Oseltamivir Phosphate Dry Suspension, and Tedizolid Phosphate for Injection—as well as one exclusive product, Cefoxitin Sodium/Glucose Injection for Injection, have been directly transferred to the regular directory. Among them, Cefoxitin Sodium/Glucose Injection for Injection and Oseltamivir Phosphate Dry Suspension have been included in the eighth national procurement round, while the remaining three products have been incorporated into the ninth national procurement round.

 

Data shows that, as of now, Lacosamide Oral Solution, Oseltamivir Phosphate for Suspension, and Tedizolid Phosphate for Injection have been approved.EnterpriseThe number exceeds 10, and with the implementation of the 2023 medical insurance directory, the competition for the aforementioned products will become even more intense.

 

The number of companies involved in the 16 non-exclusive products newly added to the medical insurance directory through bidding is less than 10. Among them, the sales revenue of ceftazidime avibactam sodium for injection in Chinese public medical institutions exceeded 500 million yuan in 2022. Pfizer has been occupying a leading market position. Since 2021, domestically produced generic drugs have been approved one after another. Qilu Pharmaceutical, Kelun Pharmaceuticals, and Nanjing Youker Biopharmaceutical will seize the market share of the original drug with the help of medical insurance.

 

Sales of Ambroxol Hydrochloride Solution for Inhalation in Chinese public medical institutions exceeded 200 million yuan in 2022. The path to reimbursement for this product has been tortuous, appearing on the formal review lists in 2020, 2021, 2022, and 2023. To date, the number of companies that have received approval for this product has risen to four, and its inclusion in the reimbursement list may become a new opportunity for the product’s increased sales.

 

Notably, Tetrabenazine Tablets and Nitisinone Capsules currently only have imported products approved, presenting an opportunity for Chinese pharmaceutical companies to seize the chance to develop generics.

 

　　04、2023 Medical Insurance Bonanza Qilu Pharmaceutical、Zhengda Pharmaceutical、Kelon Pharmaceutical、Yangtze River Pharmaceutical

 

Corporate Groups with ≥5 New Products Added to the 2023 Medical Insurance Catalog

 

Statistics show that the 126 newly added products involve more than 140 enterprise groups (product approval dates were counted as of December 13). Qilu Pharmaceutical (including subsidiaries) has successfully transferred two products to the regular catalog and secured the inclusion of six products through negotiation/bidding, leading in quantity. Among these, Irulark tablets are classified as Class 1 new drugs, while Aripiprazole Orally Disintegrating Film and Montelukast Sodium Orally Disintegrating Film are improved new drugs.

 

Chia Tai Pharmaceutical's Nanjing Chia Tai Tianqing Pharmaceutical has one product transferred to the regular catalog, three products successfully included in the insurance through negotiation/bidding, with the exclusive product Lubiprostone Soft Capsules among them; Chia Tai Tianqing Pharmaceutical Group has two products successfully included in the insurance through negotiation/bidding, and Chia Tai Pharmaceutical (Qingdao) has one product successfully included in the insurance through negotiation/bidding.

 

Kelun Pharmaceuticals (including subsidiaries) has one product transferred to the regular catalog, and five products successfully included in the insurance coverage through negotiation/bidding. The company's new dual-chamber bag for powder and liquid, as well as its new multi-chamber bag products, are expected to enter a new growth phase.

 

Yangtze River Pharmaceutical Group (including subsidiaries) has successfully transferred two products to the regular catalog and secured the inclusion of three products through negotiation/bidding, among which the exclusive traditional Chinese medicine Lianyu Burn Ointment is listed.

 

Appendix: Overview of New Products Added to the 2023 National Medical Insurance Drug Catalog

Source: MiNeiNet database, National Healthcare Security Administration, etc.