Registration and classification of new chemical drugs have been implemented, and all kinds of applications have been surging

On July 11, CDE undertook the first class 1 new drug declared according to the registration and classification of new chemicals On July 26, CDE undertook the first category 5.1 and 5.2 imported drugs declared according to the registration classification of new chemicals On August 1, CDE undertook the first three generic drugs declared according to the registration classification of new chemical drugs On August 8, CDE undertook the first class 4 generic drugs and class 2.3 improved new drugs declared according to the registration classification of new chemical drugs It is worth mentioning that after the formal implementation of the registration classification of new chemical drugs, the response of imported drugs was quite rapid As of August 14, six imported varieties had reached CDE The magic formula of medicine has introduced the newly emerging class 1 new drugs and class 3 generic drugs before, which will not be covered here Today, we mainly focus on class 4 generic drugs, class 2.3 improved new drugs and class 5 imported drugs under the registration and classification of new chemical drugs None = "shifumousedown ('shifu_013 ')" style = "margin: 5px 0px 0px; padding: 10px; max width: 100%; box sizing: border box! Im assistant; word wrap: break word! Im assistant; border: none;" > the first four categories of generic drugs, pemetrexed disodium for injection declared by Sichuan Huiyu This is a direct application for production Pemetrexed disodium can be used with cisplatin in the first-line chemotherapy or non operative malignant pleural mesothelioma in patients with locally advanced or metastatic NSCLC According to the database, at present, there are only lyophilized dosage forms of the product, 14 domestic products have been listed, 1 imported product has been listed, and 23 are still in the application stage None = "shifumousedown ('shifu_t_013 ')" style = "margin: 5px 0px 0px; padding: 10px; max width: 100%; box sizing: border box! Im assistant; word wrap: break word! Im assistant; border: none;" > the first class 2.3 modified new drug note: 2.3 is a new compound preparation which is not listed at home and abroad and contains known active ingredients Novartis qvm149 is an ICs (inhaled steroid) / Laba new drug, which is composed of indedarol, a long-acting β 2-receptor agonist, gronbromonium, a long-acting muscarinic receptor antagonist, and mometasone, a corticosteroid, for the treatment of moderate / severe asthma Qvm149 once applied for clinical application in February this year none="shifuMouseDown('shifu_t_013')" style="margin: 5px 0px 0px; padding: 10px; max-width: 100%; box-sizing: border-box !im portant; word-wrap: break-word !im portant; border: none; "> class 5 imported drug ixazomib (isazomib) capsule: proteasome inhibitor developed by Takeda company, which was approved by FDA in November 2015, is used for the treatment of multiple myeloma There are no other companies in China to declare it Bortezomib and kafezomib are other proteasome inhibitors that have been listed abroad, among which bortezomib from Janssen has been listed in China Salmeterol and fluticasone propionate are the main ingredients of salmeterol, which is the main product of GSK respiratory system treatment drug, and the trade name is Seretide, which is used to treat asthma and COPD Novartis trading's application type is imported generic drugs At present, only one GSK inhaler is listed in China, 11 of which are under research Enteltamip: a compound of tenofovir fumarate and enteltamip developed by Gilead It is a nucleoside reverse transcriptase inhibitor (NRTI) for the treatment of HIV infection in adults At present, there are no other domestic enterprises to declare Dhaltamivir hydrochloride: dhaltamivir is an NS5A replication complex inhibitor used to treat patients with genotype 3 chronic hepatitis C (HCV) Dalatawei tablet has been listed in the European Union, the United States, Japan and other places This time, it is the API declared in China Bristol Myers Squibb applied for clinical application for dalatawei capsule and dalatawei tablet as early as May 2010, but they were not approved In 2011, dalatawei tablet applied for clinical application again and was approved in 2013 The application history is as follows: dalatawei tablet has no domestic listed manufacturers at present, Zhengda Tianqing, Zhongqi, and Shanghai Xingtai are in the clinical application stage Ferric pyrophosphate citrate: the ferric pyrophosphate citrate declared by tag medicine is used to treat the iron loss of dialysis patients with chronic kidney disease The drug was developed by Rockwell medical and approved by FDA in January 2015 In April this year, tiger pharmaceutical ferric pyrophosphate citrate injection applied for clinical application, and is currently queuing up There are no other domestic enterprises applying for the product Attachment: new version of chemical medicine registration classification 1 Innovative drugs not listed at home and abroad It refers to a new drug with clear structure, pharmacological effect and clinical value 2 Improved new drugs not listed at home and abroad It refers to the drugs with obvious clinical advantages, which optimize the structure, dosage form, prescription process, route of administration, indications and so on based on the known active ingredients 1) An optical isomer containing a known active ingredient prepared by resolution or synthesis, or an ester of a known active ingredient, or a salt of a known active ingredient (including a salt containing a hydrogen bond or a coordination bond), or an acid radical, a base or a metal element that alters the active ingredient of a known salt, or other non covalently bonded derivative (such as a complex, a chelate or an inclusion compound ）, and has obvious clinical advantages of APIs and their preparations 2) A new dosage form (including a new drug delivery system), a new prescription process, a new drug delivery route with known active ingredients, and a preparation with obvious clinical advantages 3) The new compound preparation with known active ingredients has obvious clinical advantages 4) A preparation containing a new indication of a known active ingredient 3 The domestic applicant imitates the drugs listed overseas but not listed in the original research drug This kind of drugs should be consistent with the quality and efficacy of the original drugs The original research drug refers to the first drug approved for listing at home and abroad, and has complete and sufficient safety and effectiveness data as the basis for listing 4 The domestic applicant imitates the drugs that have been listed on the market This kind of drugs should be consistent with the quality and efficacy of the original drugs 5 The drugs listed overseas apply for listing in China (1) the original research drugs (including APIs and their preparations) listed overseas have applied for listing in China 2) Non original research drugs (including APIs and their preparations) listed overseas apply for listing in China