Rare epilepsy "life-saving drug" domestic chlorbachan was approved for listing

After October, it may be available at designated hospitals

- On September 21, Chengdu Business Daily - Red Star News reporter learned from Yichang Renfu Pharmaceutical Co.

- The reporter also learned from the official website of the State Drug Administration that in the "2022 September 19, 2022 Drug Approval Certificate Document to be Collected Information Release", the two chlorobachan tablets applied for by Yichang Pharmaceutical were "National Pharmaceutical Approval H20223657" and "National Pharmaceutical Approval H20223658", and the approval date was September 14, 2022
.

- According to previous reports, Clobacham is a broad-spectrum anti-seizure drug for the treatment of rare epileptic diseases and is used as an anti-epileptic drug in more than 100 countries; However, Chlorbachan belongs to the second class of psychotropic control drugs in China, at that time, it was not approved for marketing in China, and the families of the children could only purchase the regularly listed Chlorbachan from abroad, and with the increase of the customs investigation and punishment of the drug Chlorbajan, many children faced the risk
of drug discontinuation.

The first chlorobachan in China was approved

On September 20, according to the WeChat public account of Yichang Renfu Pharmaceutical Company, the company recently received the "Drug Registration Certificate" of chlorobachan tablets approved and issued by the State Drug Administration, which was the first to be approved
in China.

On the 21st, a staff member of the office of Yichang Renfu Pharmaceutical Company told reporters that at present, the company is coordinating multiple departments to promote drug production and other work, so that patients can use drugs as soon as possible, but the specific time to prescribe drugs is still uncertain
.

On the same day, a sales staff member of the company said that Chlorobachan belongs to the second class of psychotropic drugs, can not be marketed and circulated, the drug needs to be purchased in designated hospitals, it is estimated that after October can be purchased in designated hospitals to buy domestic Chlorobachan tablets
.

In November 2021, Chengdu Business Daily-Red Star News released an exclusive report "Mother of Drug Dealers", revealing that the mothers of several children with rare epilepsy were charged with "smuggling, transporting and selling drugs"
for helping purchasing agents collect clobachan packages mailed overseas.

In December 2021, the National Health Commission publicly responded that it is organizing a thorough mapping of the diseased groups to understand the demand for drug dosage, and coordinating relevant institutions and departments to organize centralized applications and imports in accordance with the relevant provisions of the Drug Administration Law to meet the needs
of patients for medication.

On March 29, 2022, the National Health Commission issued an announcement for public comment on the "Chlorbachan Temporary Import Work Plan", "In order to meet the urgent need for clinical drugs in Chlorbajan, in accordance with the relevant provisions of the "Temporary Import Work Plan for Drugs Urgently Needed in Clinical Practice", the temporary import work plan
for Chlorbachan is formulated.

On June 29, 2022, the State Drug Administration issued the Notice on Printing and Distributing the < Work Plan for the Temporary Import of Drugs Urgently Needed in Clinical Practice> and the < of the Temporary Import Work Plan for Chlorobazam and the >", saying that in order to further improve the drug supply guarantee policy and meet the people's demand for a small number of specific clinically urgent drugs that have been listed abroad and are not available in China, and to take this as an opportunity to form a relatively complete temporary import plan for drugs that are urgently needed clinically, the National Health Commission, The State Drug Administration recently issued the "Temporary Import Work Plan for Drugs Urgently Needed for Clinical Needs" and the "Temporary Import Work Plan for Chlorbachan"
.

Family members: I hope to prescribe the drug as soon as possible

On September 21, the relevant person in charge of Yichang Renfu told reporters that rare epilepsy is characterized by the onset of early childhood, most of which are epileptic encephalopathy that lasts for life, the causes are complex and diverse, but the available drugs are very limited, which is refractory epilepsy; The efficacy of clobazhan for rare epilepsy is exact, compared with traditional drugs, there are fewer sedation and center-related adverse reactions, less drug interactions, and better tolerability, which has been unanimously recognized by
the majority of clinical experts.

"Although patients have an urgent clinical need for chlorba, because of the dual attributes of orphan drugs and national second-class psychotropic drugs, the market is small, the investment is large, the income is low, and the research and development and sales momentum of pharmaceutical companies is insufficient, so that Chlorbachan has not been listed
in China for a long time.

The relevant person in charge of Yichang Renfu also introduced that in 2017, the company decided to apply for the establishment of the Chlor Bazhan project after paying attention to the "Second Batch of Recommendations for Encouraging Research and Development of Children's Drugs Declaration" issued by the former National Health and Family Planning Commission and other institutions
.

The relevant person in charge also said that the company will put the guarantee of drug accessibility in the first place and bring better treatment opportunities for domestic children; In response to the demands of parents of children, the company is ready to start the declaration of chlorbachan entering the national medical insurance directory in 2023, and will also prepare for cooperation with third-party public welfare funds to carry out drug assistance
for patients from economically difficult families.

"I can't wait to go to the hospital to prescribe medicine!" On September 21, the family of a child with rare epilepsy told reporters that after the shortage of chlor Bachan caused social concern, "every one or two months, there will be good news coming over, and the solemn statement of the relevant state departments will carry out the import work of chlor Bachan and the declaration of domestic pharmaceutical companies.

Another patient and the owner of the "One Meter Sunshine Patient Group" group Min Wen told reporters that it is finally possible to see hope, domestic chlorbachan has been approved for listing, overseas chlorbachan has also begun to import, and the problem of chlorbachan's medication can soon be solved
.

Chengdu Business Daily - Red Star News reporter Wang Jianqiang

Comprehensive surging news