On October 29, the 2024 national negotiations entered the third day, and a group of companies such as Yangtze River, Yiling, China Resources Sanjiu, Jichuan, and Jianmin took their traditional Chinese medicine varieties to the stage. Before entering the venue in the afternoon, the overall atmosphere on the scene was relatively relaxed. When the staff of the Medical Insurance Bureau called the roll, some company representatives did not respond in time. Other company representatives joked, "Okay, automatically give up," and everyone laughed. At the scene, many representatives of traditional Chinese medicine companies showed strong confidence in their products, and mentioned the advantages of traditional Chinese medicine over chemical medicine in the treatment of the same disease during the conversation. At the same time, this year's national negotiations focus on "high-quality, cost-effective innovation" and also apply to traditional Chinese medicine. A representative of a traditional Chinese medicine company with exclusive varieties emphasized that "(in the negotiation) the clinical efficacy must be made clear." In addition, the rising cost of Chinese medicinal materials is one of the common pain points faced by Chinese medicine companies present, but representatives said, "Let's talk about it first, the next step is the production capacity issue", "build the reputation of the hospital first", and "strive to make it clinically available."

According to an incomplete review by Cyber Blue, the number of Chinese patent medicines that have passed the formal review this year is about 60. For example, Jianmin Group's pediatric purple shellfish lung syrup was approved for listing in the second half of 2023. It is a 1.1-class Chinese medicine for children, mainly used to evacuate wind-heat, promote lung function and relieve cough.

China is the world's second largest pediatric drug market, and the national negotiation policy is constantly tilted towards children's drugs. If the relevant children's drug products are successfully included in this year's national medical insurance catalog, there may be an opportunity to achieve rapid volume growth. From the perspective of the companies participating in the negotiations, tumor drugs are also the focus of the third day, and many representatives of companies related to tinib drugs entered the negotiation site.

Jin Chunlin, director of the Shanghai Health and Health Development Research Center, once pointed out that this year's national negotiations are likely to give a better preference to innovative drugs, especially exclusive innovative drugs. He specifically mentioned 7 innovative drugs that have attracted much attention this year and are more likely to be negotiated. Dizhe Pharmaceuticals, which occupies two of the exclusive varieties - Suvotinib tablets and Golixitinib capsules, entered the negotiations this morning.

Suvotinib tablets were approved for marketing in China in August 2023 for the treatment of second-line EGFR exon 20 insertion mutation non-small cell lung cancer. There are no competitors in the domestic market, and the annual treatment cost is about 465,000 yuan; Golixitinib capsules were launched in China in June this year and are suitable for adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) who have received at least first-line systemic treatment in the past. There has been no innovative drug launched in this disease treatment field for nearly ten years.

In the first half of this year, these two drugs brought Dizhe Pharmaceuticals 204 million yuan in sales revenue. Its patients are still concentrated in large cities and large hospitals, and there is a large room for improvement in penetration. Wu Qingyi, deputy general manager and chief commercial officer of Dizhe Pharmaceuticals, made it clear in an interview in July that they would "actively prepare for medical insurance negotiations for Suvotinib." In the afternoon, Qian Yun, vice president of market access and general manager of the commercial department of Pfizer China, appeared. It is reported that Pfizer's lorlatinib tablets have long been included in the national medical insurance catalog, and this time they are negotiating for renewal.

Bristol-Myers Squibb's deuterated corticosteroid tablets are an exclusive variety, suitable for adult patients with moderate to severe plaque psoriasis who are suitable for systemic treatment or phototherapy. In this treatment field, Novartis's secukinumab and Eli Lilly's ixekizumab have both entered the medical insurance. Among them, ixekizumab took the initiative to reduce its price in 2021, and reduced its price again after being included in the medical insurance catalog. The sales of both drugs have maintained rapid growth.

When applying, pharmaceutical companies generally consider the therapeutic field of the drug, the price of products that have entered the medical insurance catalog, and other factors, and then select relatively suitable reference products and submit them with the materials. For example, the reference drug given by BMS in the application materials for the adjustment of the national medical insurance drug list in 2024 is ustekinumab injection (45mg/0.5ml), with a price of 20,079 yuan. Shanghai Beierda's Rizitinib Mesylate Capsules are suitable for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have experienced disease progression during or after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) and have been confirmed to have EGFR T790M mutation-positive.

The reference drug given by Beierda in the application materials is Befortinib Mesylate Capsules (25mg), with a price of 102,974.84 yuan (most patients can successfully increase the dose to 100mg per day after 21 days of 75mg induction). Shanghai Yizhong's paclitaxel polymer micelle for injection is its only drug on the market. It is combined with platinum for the first-line treatment of patients with epidermal growth factor receptor (EGFR) gene mutation-negative and anaplastic lymphoma kinase (ALK)-negative, locally advanced or metastatic non-small cell lung cancer (NSCLC) that cannot be surgically removed. The reference drug given in the application materials is paclitaxel liposome for injection (30mg), priced at 13,680 yuan. According to Frost & Sullivan, from 2017 to 2021, the total market value of EGFR-TKI in China will increase from 3.1 billion yuan to 13 billion yuan, with an annual compound growth rate of 43.1%. It is estimated that by 2025 and 2030, the total market value of EGFR-TKI in China will reach 28.5 billion yuan and 52.2 billion yuan, respectively. With the participation of multiple EGFR-TKIs in the national negotiations, its competitive landscape is about to change.

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