Day Two of China's 2023 National Reimbursement Drug List Negotiations: Qilu Pharma Optimistic, Fosun Does Not Negotiate CAR-T

Source: China News Service - Jingwei Author: Wang Yuling

On the 18th, during the ongoing medical insurance negotiations, a group of well-known pharmaceutical companies appeared, including Kelun Pharmaceutical, AstraZeneca, Zai Lab, Fosun Pharmaceutical, Zhongsheng Pharmaceutical, Haisco Pharmaceutical, Sanofi, Hengrui Pharmaceutical, and Qilu Pharmaceutical.

From the atmosphere of the negotiation, it was generally peaceful. In the afternoon, the leader of Qilu Pharmaceutical appeared and responded to the media's inquiry about the negotiation by saying, "Pretty good, pretty good."

Negotiate hypoglycemic, anti-infective and other drugs

According to an incomplete summary by China News Service on the scene, the non-exclusive drug bidding and some in-and-out directory drug negotiations were carried out on the 18th. The companies involved in the non-exclusive drug bidding include Kelun Pharmaceuticals, Beijing Ruiye Pharmaceutical, Nanjing Entai, Xi'an Wanlong, Xinjiang Tefeng, and Zhengda Pharmaceuticals (Qingdao) Co., Ltd.

In addition, the formal review is the stepping stone to enter the medical insurance negotiation. According to the list of drugs that passed the formal review in 2023 released by the National Healthcare Security Administration, a total of 386 drugs passed the formal review, including 222 drugs outside the directory and 164 drugs within the directory.

Combined with the pharmaceutical companies present and the drugs that passed the formal review list, the negotiation categories on the 18th included hypoglycemic, anti-infective, and others.

Wuhan Jiuan Pharmaceutical Research Institute Co., Ltd. has only one approved drug, Metformin Hydrochloride Extended-Release Tablets (IV). This product is used for adult Type 2 diabetes patients who have not responded to diet control and exercise alone. It can be used as monotherapy or in combination with sulfonylureas or insulin.

Sinotherapeutics Inc.'s approved drug is only Sitagliptin and Metformin Hydrochloride Extended-Release Tablets (Ⅱ), which is suitable for adult patients with type 2 diabetes who are receiving combined treatment of Sitagliptin and Metformin Hydrochloride Extended-Release Tablets.

Hua Medicine's approved drug is Dorzagliatin tablets, which are used as monotherapy or in combination with metformin to treat type 2 diabetes.

Moreover, on the morning of the 18th, Huang Bin, Vice President of AstraZeneca China and Head of Corporate Affairs and Market Access, also led a team to appear at the scene of the medical insurance negotiations. Huang Bin revealed that only one category was discussed today.

From the list of AstraZeneca's approved drugs, it includes Dapagliflozin Metformin Hydrochloride Extended-Release Tablets (I), Eculizumab Injection, Selumetinib Sulfate Capsules, and Trastuzumab Deruxtecan for Injection, among others.

Among them, Dapagliflozin and Metformin Hydrochloride Sustained-Release Tablets (I) are used for blood sugar control. It is a once-daily, fixed-dose combination of an SGLT2 inhibitor and metformin hydrochloride sustained-release agent.

AstraZeneca's most notable product this time is Trastuzumab Deruxtecan for Injection (i.e., DS8201), which was approved for marketing at the end of February 2023. It is used to treat adult patients with unresectable or metastatic HER2-positive breast cancer who have previously received one or more anti-HER2 drug treatments.

Notably, Novo Nordisk's semaglutide participated in the medical insurance renewal negotiation as a listed drug. The drug has gained significant attention for its weight-loss effects and is referred to as a "weight-loss miracle." However, the weight-loss indication for semaglutide has not yet been approved in China. Its inclusion in the medical insurance scheme is for blood sugar control in adult patients with type 2 diabetes. However, at today’s negotiation site, China News Finance did not spot any representatives from the company.

In addition, negotiations for anti-infective drugs were also held on the 18th. Zai Lab appeared at the negotiation site, with two approved products: Omadacycline Tosylate Tablets and Efgartigimod Alfa Injection.

Among them, the Efgartigimod Alfa Injection is a rare disease medication for myasthenia gravis, which was launched in June 2023. This drug is suitable for use in combination with conventional treatments to treat adult patients with generalized myasthenia gravis (gMG) who are positive for acetylcholine receptor (AChR) antibodies.

Omadacycline tosylate is a new anti-infective drug. In terms of its competition in the same category, Omadacycline injection was included in the medical insurance through negotiations in 2022. The two products are of the same molecular formula and have consistent indications. Omadacycline is currently the only third-generation tetracycline-class drug available in an oral formulation.

Jinhua Zhong from China News Service learned from an insider that rare disease drugs might be negotiated the day after tomorrow. Based on this, Zai Lab's negotiation category today might be Omadacycline Tosylate.

Similarly, Everest Medicines, which also has anti-infective products, appeared at today's negotiation site. The form review list shows that Everest Medicines' Eravacycline Hydrochloride for Injection has passed the review. This product was approved for marketing in March 2023 and is a broad-spectrum, fluorinated tetracycline-class intravenous antibiotic, suitable for treating complicated intra-abdominal infections in adults.

Fosun Pharmaceutical Didn't Discuss CAR-T

From the negotiation situation of other pharmaceutical companies, on the morning of the 18th, Fosun Pharmaceutical appeared at the negotiation site, but its negotiation category may not be the much-anticipated CAR-T product Axicabtagene Ciloleucel Injection (brand name Yikaida).

At the scene, China News经纬 heard that the enterprise name called by the staff of the National Medical Insurance Administration was Jiangsu Fosun Pharmaceutical Sales Co., Ltd., and its approved product is Etecaphene Hydrochloride Injection. However, Axicabtagene Ciloleucel Injection belongs to Fosun Kite Biotechnology Co., Ltd.

Not long ago, Juventas announced that its CAR-T treatment product Yuan Ruida (Nageo Lunce Injection) has been approved for marketing, used to treat adult relapsed or refractory B-cell acute lymphoblastic leukemia. Thus, China now has four CAR-T products on the market, once again bringing the payment issue of high-cost drugs back into the public spotlight.

The CAR-T products that made it to the list for formal review in this year's medical insurance negotiation are Fosun Kite's aforementioned product and JW Therapeutics' Relmacabtagene Autoleucel Injection (brand name: Bynoda). Both products had previously been on the formal review list but ultimately did not make it into the medical insurance program. Additionally, IASO Biotherapeutics' Equecabtagene Autoleucel Injection, which was approved just in time at the end of June, did not appear on the formal review list and thus missed out on this year’s medical insurance negotiation.

Etelcalcetide Hydrochloride Injection, a new hyperthyroidism drug introduced through commercial authorization by Fosun Pharmaceutical in collaboration with Amgen. This injection inhibits the secretion of parathyroid hormone (PTH) by chief cells of the parathyroid gland, thereby reducing serum PTH levels.

Bayer's product that passed the review this time is Vericiguat tablets. Relevant negotiators appeared at the negotiation site on the afternoon of the 18th. Public information shows that Vericiguat tablets are a new drug for heart failure, suitable for adult patients with symptomatic chronic heart failure with reduced ejection fraction (ejection fraction <45%) whose condition has stabilized after recent decompensated heart failure treated intravenously, in order to reduce the risk of hospitalization for heart failure or the need for emergency intravenous diuretic treatment.