There is an update on the pricing of the first generic version of clobacan in China.
On the morning of October 22nd, Yichang Renfu Pharmaceutical Co., LTD., the R&D company of the rare disease drug clobacan tablet, held the online launch conference of Enos [R] Clobacan in China.
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At the meeting, Du Wentao, president of Yichang Renfu Pharmaceutical Co., LTD., introduced that the price of Enos clabazan tablets was 84 yuan per box (28 tablets per box, with specifications of 10mg/ tablet), which was the lowest price in the world.
According to IQVIA, Clobacan oral formulations generated worldwide sales of approximately $300 million in 2021. Yichang Renfu submitted the application for the registration of Clobacan tablets in accordance with the requirements of the new registration classification of chemical drugs in March 2022, and the cumulative R&D investment of the project so far is about 45 million RMB.
Domestic chlorbacan tablets on the market
Publicly available information shows that clobacan is a drug used in the treatment of children with rare and refractory epilepsy, which can effectively control seizures.
Chlorba occupies the structure
It was first marketed in the Philippines in 1967 and is now available in the United States, United Kingdom, France, Germany, Italy, Argentina, India and many other countries.
However, in China, clobar belongs to the second class of psychotropic drugs. According to the Translation Table of Dependence of 100 Types of Narcotic Drugs and Psychotropic Substances under Control issued by the Office of National Narcotics Control Commission in 2017, 1 gram of clobar is equivalent to 0.1 mg of heroin.
Clobacan has been under strict control before. As a broad-spectrum anti-seizure drug, it has not been approved in China, and many families of children have to choose to buy the drug from overseas.
According to the Global Epilepsy Report released in 2019, the risk of abnormal or premature death in epilepsy patients is three times higher than that in normal people. Epilepsy accounts for the fifth place of the global burden of disease and is a public health issue worthy of great attention.
There are 9 million patients with epilepsy in our country, including about 6 million with active epilepsy. Various reasons lead to a high proportion of patients who cannot receive regular treatment.
The domestic chlorba accounted for the market, for the majority of children with epilepsy and their families, is of great significance.
The Clobacan daigou incident
At 9 am on March 18, 2022, the Zhongmou County People’s Court held a public hearing on the case of a family member of an epileptic child in Zhengzhou who bought clobacan from overseas by “Iron Horse Ice”.
During the trial, the defense lawyer pleaded not guilty, and “Iron Horse Glacier” also defended himself, arguing that his behavior was essentially for the drug use of other patients and his own children, not a crime, let alone a drug dealer.
“Iron Horse Glacier” daigou Cloba accounted for the quantity and selling price, “the public prosecution alleges more than 100 boxes, the price, according to its own account, is the lowest among daigou:” At the beginning, I did not raise the price when I helped others to buy, then I added a little price for postage.”
However, prosecutors still believe that the “Iron horse glacier” acts constitute trafficking, drug trafficking crimes, sentencing recommended a year to four months a year.
Then, 132 patients submitted a joint petition letter to Zhongmou County Court. They are all family members of children with epileptic encephalopathy. They got to know each other through wechat group and were very concerned about the situation.
Usher in a new turning point
In response to the urgent needs of children, in March this year, the National Health Commission and the National Food and Drug Administration drafted the Work Plan for the Temporary import of Clobacan, and solicited public opinions. The final draft was released at the end of June, and a list of 50 medical institutions leading the import and use of clobacan was published.
Shortly after, Clobacan (10mg/ tablet) from the original Sanofi arrived at Shanghai Port; On September 22, temporarily imported Clobal was the first in China to depart from Peking Union Medical College Hospital.
On September 20, Renfu Pharmaceutical, a subsidiary of YichangRenfu Pharmaceutical Co., LTD., announced that its generic drugs, Lobecan tablets (10mg, 20mg), were officially approved for the combined treatment of epileptic seizures in patients aged 2 years and above with Lennox-Gastaut syndrome (LGS), becoming the first copy of the product in China.
In the recent listing meeting, Yichang Renfu Pharmaceutical said that the company is ready to start the work of chlorbacan tablets entering the national medical insurance catalog in 2023, and will prepare to cooperate with third-party public welfare institutions in the later stage, to carry out medication assistance for families with economic difficulties.
In addition, to improve the medication compliance of children with epilepsy, the company will also promote the development of clobacan oral liquid.
The data show that the human bioequivalence study (pre-test) of clobacan oral suspension in China has also been completed.
conclusion
In the past 10 years, the number of people covered by medical insurance has increased from 540 million to 1.36 billion, and China has built the world’s largest basic medical security network, and made visible progress in including drugs for rare diseases in medical insurance.
Up to now, 2,860 kinds of drugs have been listed in the national Medical insurance list, including 67% of the drugs for rare diseases in China, which has greatly reduced the burden of medication for patients. The domestic clobacan on the market this time, a good start for rare disease medicine.
There is a shortage of drugs for rare diseases in China. In addition to the obstacles in market transactions and drug circulation, there is an urgent need to solve the problems of the scarcity of specific drugs and the slow progress of research and development.
Post time: Oct-28-2022