[Transfer] 2 million sky -high therapy hard carried the cold winter

Source: Archimedes Biotech/Archimede

CAR-T cell therapy is under pressure testing domestic payment capabilities.

A single needle 1.2 million yuan or 1.29 million yuan is a drug fee, plus supporting medical expenses, with a total price of about 2 million yuan.

CAR-T commercialized significance beyond itself, and the cicada is cut. There must always be a warrior to touch the ceiling, test the environment for cutting-edge therapy, and even the tolerance of the innovative exploration of the pharmaceutical industry.

By this month, Fosun Kate Aquelun's injections have cumulatively treated more than 200 patients, and Yin Mingjuerki Olun's injection completes 260 patients' return treatment (including clinical research and commercialization).

For more than a year of domestic CAR-T, there are less than 500 patients who have completed the return. Yaoming Juuo's production base can meet the needs of per 2,500 cases of autologous CAR-T cells, and most of the production capacity is idle.

In the case where the downstream CAR-T manufacturer loses its losses and does not measure it, the upstream CGT (cell gene therapy) CDMO is also under pressure. The cell therapy industry chain lives in the cold at present, but it will be shone in the future of cure cancer.

01

300,000 yuan to pay the ceiling

Due to the differences in the payment environment, there is a conversion ratio of American Chinese medicine economics, about 1/7,

CAR-T therapy is priced in the United States. Nuohua Kymriah is US $ 475,000 and Geely's Yescarta is US $ 373,000. The therapy enters 475,000 to 373,000 RMB in China to reach a balanced price that can be accepted by one party.

According to the "International Journal of Cancer", the cost of production of single-person CAR-T is about $ 80,000. In the early stage of the commercialization of Yaoming Juari Olun, the gross profit margin was only 29.4%, and the production cost of single-person CAR-T production was about 700,000 yuan. In addition, the cost of R & D, sales, and management was actually losing money. The cost is expected to be reduced to 500,000 to 55,000 yuan in the second half of this year, and the gross profit margin will be increased to more than 35%. In the middle (2-3 years), the imported materials are replaced by domestic supplies, which will further reduce the cost to about 450,000 yuan. 3-5 years) implemented new technologies to simplify/replace/merge unit operations, so that the next generation of CAR-T products has a lower cost.

What is the ceiling paid by the medical insurance?

There are nearly 3,000 drugs in the medical insurance directory, and the maximum payment amount of medical insurance funds is 300,000 yuan. After the medical insurance negotiations in 2021, the leader of the expert group said: "It cannot be tall, otherwise, the medical insurance fund will be difficult to bear."

This year's medical insurance negotiations have a major suspense. Can the 300,000 yuan ceiling be broken?

How does US medical insurance support cutting -edge therapy? CMS (U.S. Medical Insurance and Medical Service Center) Pay $ 400,000 for patients with Geely CAR-T treatment through medical insurance and pay $ 500,000 for patients receiving Norhua CAR-T therapy.

CAR-T has included more than 30 cities in China. The maximum payment amount of Huhui Insurance is 500,000 yuan, which is unlimited. From March to May of this year, 4 CAR-T therapy patients passed Zhejiang Ningbo Huimin Bao products "Tianyong Ningbao", which were compensated for 58,000 yuan, 1 million yuan, 944,000 yuan, and 472,000 yuan, respectively. Hangzhou Huimin Bao's product "West Lake Yilian Insurance", Chongqing Yuku Insurance and Beijing Jinghui Insurance also completed a claims of CAR-T therapy, respectively, with the amount of 500,000 yuan, 360,000 yuan, and 1 million yuan, respectively.

The rise of Shangbao has greatly relieved the anxiety of payment, but the above patients still need to pay more than 1 million yuan at their own expense, which is unbearable to ordinary families.

The effect of cell therapy is so amazing. As of July, more than 30 patients at Shanghai Ruijin Hospital were treated with Fosun Kate CAR-T, of which 22 patients had completed the first efficacy assessment, the objective relief rate (ORR) was as high as 95.5%, and the complete relief rate (CR) was as high as 68.1% That is, 15 of them were completely relieved.

02

Domestic cell therapy enterprise panorama

Cracking the problem of the same time, you need to pay the environment and technical iteration to work together. The self-CAR-T is highly customized, and the limitations are becoming more and more obvious. The first CAR -T therapy Novartis Kymriah has been listed for 5 years and has touched its own ceiling. In the first half of this year, sales were US $ 263 million, a year -on -year decrease of nearly 12%. According to Dr. Samuel Silver, the University of Michigan's Comprehensive Cancer Center, the total cost of CAR-T therapy in the United States is at least $ 750,000, and the cost of non-drug is $ 400,000 to $ 450,000, which is roughly equivalent to the cost of medicine.

The general-purpose CAR-T (UCAR-T) can achieve the scale and standardization of the production process, which is expected to reduce the production cost by 90%. The main manufacturers of domestic manufacturers are Jixi Biology, Bei Constant Bio, Kochi Biology, Legendary Biological, Bangyao Biology, Anke Biological Stock Company, Bioshi Ji, Maoxing Bio, Kerui Gene, Senlang Bio Essence

There are 3 UCAR-T pipelines in the Hexi Bio. CD19 cell therapy GC007G user source CAR technology is the first universal CAR-T therapy that enters the clinical stage in China. It has completed IIT clinical trials in China. GC502 is a dual-targeted UCAR-T product that targets CD19/CD7 to treat acute B lymphocyte leukemia. GC027 is a UCAR-T product that targets CD7, which is used to treat acute T lymphocyte leukemia. Beiheng Biomedo UCAR-T pipeline reached 7. The fastest TA101 obtained CDE clinical trials in March this year. It is the first domestic immune cell therapy product based on CRISPR gene editing technology. GM CAR-T therapy.

There are 3 Koji Biological UCAR-T pipelines. The KJ-C2111 targeted BCMA is used to treat multiple osteoma (MM). It is currently in the IIT experiment stage and KJ-C2114 is still in the pre-clinical research stage.

A solid tumor CAR-T therapy has a wider coverage, and it can also reduce costs through large-scale production. In 2019, there were 18.5 million patients with global cancer, of which 17.3 million were physical tumor patients, accounting for 93%.

CT041, the core product of Koji Pharmaceutical, targeted CLAUDIN18.2, used to treat gastric/esophageal and gastric adenocarcinoma and pancreatic cancer. It is the first and only physical tumor CAR-T to enter the key 2 clinical trial. In the first half of 2024, the NDA was submitted to the country, and it was planned to launch a two -phase clinical trial in North America in the second half of this year.

Koji Pharmaceutical lost 376 million yuan in the first half of the year and a cash reserve of 2.74 billion yuan. It can support R & D activities of more than 4 years and control costs stronger than legendary creatures. From the perspective of market performance, the status of its domestic first-line CAR-T enterprises has been recognized.

Compared with the mature CAR-T therapy, NK cell therapy is still in the early stage, but the potential advantages are outstanding, the industrialized mass production potential is greater, the range of indications is wider, the safety is better, the cost is lower, the killing speed is fast, and it can be available. As a universal spot product. Among the domestic enterprises, Baiji Shenzhou, Youkai Rui, Chengnuo Medical, Chongqing Precision Biology, Esco, Corren Boti, British Bachel, Biography Qihan Biology, Enkai rails, Jingda Biology, He Luo New Picture, Xin Chuan Bio and Jiyin creatures.

In November 2021, the State Drug Administration approved the clinical trial application of CAR-NK cell products through Guojian Nuo's spot type, which is the first domestic NK cell therapy to enter the clinical stage. Yingbairui uses ADC thinking to develop cell immunotherapy. In the first half of this year, the financing amount in the field of NK cell therapy ranked first in 230 million yuan, and the two products were about to enter IND.

03

CGT CDMO is waiting for outbreak opportunities

The commercialization of downstream CAR-T is slow, and the upstream CGT CDMO is still in the cultivation period. It is necessary to wait until the general-purpose CAR-T is listed to achieve the industrialization volume.

He Yuan creatures may be the only profitable CGT CDMO in China. It was questioned for a while and was worried that financial data changed after listing. This year's Q2 revenue was 61.78 million yuan, a year -on -year increase of 17.9%, a decrease of 15.6%month -on -month, and a net profit of 7.96 million yuan, a decrease of 34%month -on -month. Although affected by the epidemic, the performance of the performance with the secondary market was serious.

Hengyuan Biological Semi-annual Daily is also lightening the concept of cell therapy, and highlights the positioning of its focus on gene therapy. The main clients Shenzhen Yifei, Shanghai Fu Nuojian, Kanghua Biology, Beinhane, only one is CAR-T enterprise. In the first half of the year, the CDMO business cumulatively added an order of over 130 million yuan, and the order of over 350 million yuan in hand was not executed.

The CGT CDMO revenue of Botten in the first half of the year was 11.27 million yuan, an increase of 80%year -on -year, which is the only one that has a faster growth rate, but the scale is still small. 32 service customers, a year -on -year increase of 167%; 31 new projects, an increase of 244%year -on -year; the new signing order was about 92.08 million yuan, an increase of 68%year -on -year. Boteng Biological B financing is 520 million yuan, and the current 4,000 square meters of R & D and production bases are steadily operated. This year's Q4 is expected to add 16,000 square meters of large -scale industrialized bases this year. GMP cell therapy production line and hundreds of clean workshops. Start the overseas market expansion, and the capabilities deployed in North America to develop and analyze and detect the laboratory.

In the first half of the year, Yaoming Kant's CGT CDMO revenue was 615 million yuan, an increase of 35.7%year-on-year. After adjustment, Non-IFRS gross profit-043 million yuan was adjusted, and the gross profit margin was -6.9%, which was in a loss state. The decline in gross profit is mainly due to the low utilization rate of the newly opened Shanghai Lingang operation base. It has 51 clinical trials, 9 II clinical trial projects, and 7 III phase clinical trial projects (4 of which are in the preparation stage for listing application).

Kang Long turned into a CGT CDMO in the integrated and investment stage, and the cost of overseas operations was too high, temporarily losing money.

The CGT CDMO platform (booming) is close to a profit and loss balance in 2021. In 2021, 6,400 square meters of plasmid GMP plant. In 2022 and 2023, 6,400 square meters were added. In 2024, the US production base will increase by 31,000 square meters. Rice granules and virus GMP plant. In terms of plasmid, booming creatures are the largest plasmid CDMO suppliers in China. There are 9 successful experiences of China, the United States, and South Korea. Genetherapy provides slow virus and AAV vectors. There are 3 successful applications of China and the United States, and more than 20 IND declaration of virus carrier CMC projects; MRNA plasmids, almost cooperating with all domestic MRNA vaccine companies to cooperate with South Korea The MRNA vaccine projects cooperated with American companies have also been clinically applied in South Korea and Japan; DNA vaccine provides plasmid CMC research. Yaoming Shengji and flourishing creatures are the leading international CGT CDMO leading leadership.

Disclaimer: This article is the content of Yaozhi.com, and the copyright of the pictures and text belongs to the original author. The purpose of reprinting is to pass more information, which does not represent the viewpoint of this platform. If the content, copyright and other issues are involved in the work, please leave a message on this platform, and we will delete it as soon as possible.

- END -