As a classic anticancer drug, paclitaxel has been applied in clinic for more than 30 years. The earliest paclitaxel injection was approved for marketing by FDA in 1992, and it has become an "anticancer drug star", bringing new life to many patients with ovarian cancer, breast cancer and lung cancer. At first, the raw materials of paclitaxel drugs were mainly extracted from the leaves of Taxus chinensis, and then formed by chemical transformation. Because of its good clinical efficacy, it has been developed into various dosage forms, and has been on the road of improving dosage forms, such as paclitaxel injection, docetaxel, paclitaxel albumin, paclitaxel liposome, paclitaxel polymer micelle and so on. With the continuous progress and iteration of pharmaceutical preparation technology, more dosage forms are gradually developed to meet people's various drug needs.
On September 25th, 2024, the first oral paclitaxel solution in China was approved to be listed in our company (5ml:50mg, 10ml:100mg, 30ml:300mg), and 5.1 classes of classified drugs were registered. The traditional injection is changed into an oral preparation, and patients can take it orally at home without hormone pretreatment. On the one hand, they don't have to suffer from injection, and on the other hand, the risk of phlebitis caused by injection will be reduced accordingly, but patients must grasp the dosage and time of medication and keep it away from children properly. After all, it is a cytotoxic drug, not an ordinary drug. Oral solutions can be sold in pharmacies even if they are not included in medical insurance in the future, which is due to the advantages of oral dosage forms. It is included in the dual-channel pharmacy, which is more suitable.
According to the third-party data, at present, the dosage of paclitaxel oral solution is only 30ml:300mg, and it was only started in February this year, with a price of 4,980 yuan. The provinces that have been hooked up include Jiangsu, Hainan, Hubei, Guizhou and Guangdong. Let's take a look at the current prices of other dosage forms of paclitaxel together, and we can preliminarily predict the subsequent prices of oral solutions.
1. Paclitaxel injection (mainly 5 mg: 30 mg): the basic drug, which has been included in the fifth batch of national procurement, currently has the lowest price of 13.86 yuan and the highest price of 489.32 yuan. Before, besides Squibb, there was an imported medicine from Australia Keding, which has now withdrawn from the stage of history.
2.paclitaxel liposome for injection (30mg): Nanjing Green Leaf continued to be exclusive, and no one came later. At the end of 2020, the last bus from provincial medical insurance to national medical insurance was admitted to medical insurance, and then the sales volume shrank sharply, from high-end to low-end. At present, it is still a negotiated drug during the agreement period, and the price has been maintained at 228 yuan.
3. Paclitaxel for injection (albumin-bound) (100mg): it was first listed in the United States in 2005 and entered China in 2009. In 2020, it was included in the second batch of national mining, and four enterprises bid. In the end, Qilu won the bid, and the other three were selected, with 1150 yuan for Xinji, 788 yuan for Hengrui and 747 yuan for Shiyao. In March of the same year, National Medical Products Administration immediately announced the suspension of import, sale and use because the domestic flight inspection failed, which broke the quality myth of the original drug. The National Joint Procurement Department immediately abolished the qualification of Xinji, and Hengrui and Shiyao replaced the relevant provinces.
Up to now, nine domestic companies have been approved, including 598 yuan from Daoen, Hebei, 113.8 yuan from Kelun Pharmaceutical, 690 yuan, 344.4 yuan from jiangsu hengrui, 736 yuan from 780 yuan, 113.6 yuan from Kanghe Bio, Jiangsu, and 986 yuan from Qilu Pharmaceutical (Hainan).
Four years later, on May 10th, 2024, National Medical Products Administration announced the resumption of import, sale and use of paclitaxel for injection (albumin binding) by Xinji Pharmaceutical, a subsidiary of Bristol-Myers Squibb. When I came back, the market was already the world of generic drugs. I had to love it, but now it is dispensable, and everything can only be started all over again.
4. Paclitaxel polymer micelle for injection (30mg): Shanghai Yizhong Pharmaceutical Co., Ltd., a class 2.2 chemical drug, was approved for listing in October 2021, bearing the aura of the "Thirteenth Five-Year Plan" national major new drug creation technology major project. Brand-new paclitaxel dosage form, through the polymer synthesis technology, has creatively developed the pharmaceutical excipients which are precisely matched with the active ingredients of natural paclitaxel and have extremely narrow distribution coefficient, and the innovative paclitaxel dosage form formed by nanotechnology has a particle size of 18-20 nanometers. The starting price is 1690 yuan, and it has been at its own expense for three years. At the end of 2024, the country talked about access to medical insurance, which was 376 yuan. The price is still very good. After all, it is the first micelle listed in China, and it is an innovation from 0 to 1.
It is bold to speculate that polymer micelles may be the reference direction of oral solutions. This year's national talks started at the end of April, and then no substantive progress has been made so far. Class C catalogue, with a high probability, has also stagnated because of the lack of money. Therefore, there is a high probability that it will be finished by the end of June at the latest. The innovative drugs that were approved at the end of May a few days ago seem to get the signal of ending at the end of May, depending on the final plan this year. Last year, the draft of the proposal was released on June 13th, the formal draft of the proposal was released on June 28th, the results of formal review were announced on August 7th, the results of formal review were announced on August 27th, and the results of expert review were released on September 14th (self-inspection in the enterprise system, not external).
With a pinch of fingers, there should be news soon this year. The BIA and CEA reports of enterprises with products this year should be implemented as soon as possible, and it is necessary to be hard to strike while the iron is hot. Will this year, like last year's restrictions on electrolytes, collectively restrain certain drugs, whether the overall plate will continue to be tightened or appropriately relaxed, and whether there will be new adjustments except for which conditions, and whether the second class of improved new drugs will usher in benefits ... Let's look forward to it with many questions.
Disclaimer: This article is only for the purpose of knowledge exchange and sharing and popular science, and does not involve commercial propaganda, and is not used as relevant medical guidance or medication advice. If the article is infringing, please contact to delete it.
Product recommendation of our company：
1.220901-65-5 https://www.bicbiotech.com/product_detail.php?id=6310
2.154650-22-3 https://www.bicbiotech.com/product_detail.php?id=6311
3.864266-29-5 https://www.bicbiotech.com/product_detail.php?id=6312
4.159020-59-4 https://www.bicbiotech.com/product_detail.php?id=6313
5.1000895-80-6 https://www.bicbiotech.com/product_detail.php?id=6314
