[Yao Kejun] we are looking forward to the arrival of the rare disease SMA! The world's first anti-PD-L1 monoclonal antibody has been applied for domestic listing; there are Hengrui, xinlitai, China Resources Shunfeng generic drugs

Highlights: 1 Spinraza injection, a rare SMA drug, shows "approval completed - to be certified"; 2 Bayer has another drug to be listed in China; 3 Fuhong Hanlin takes the first domestic biological similar drug; 4 Will Hengrui take the first sodium bicarbonate ringer injection in China? 5 Xinlitai zuoxiracetam sustained release tablets were approved; 6 After the approval of Huarun Shunfeng pharmaceutical aluminum magnesium carbonate chewing tablets, the conformity evaluation of Chongqing Huasen? 7 Class 3 heavy-duty imitations of Enhua and TIANYAO have been accepted; 8 The world's first PD-L1 monoclonal antibody has been listed in China This week (February 22 March 1), in the application for production drugs undertaken by CDE, there are 4 new drugs, 4 imported drugs and 13 generic drugs in total On February 25, the import application of spinraza injection declared by Kuntai enterprise management (Shanghai) Co., Ltd showed "approval completed - to be prepared" Spinraza (nusinersen), developed by Ionis pharmaceutical company in California, has been granted a series of clearance cards by FDA, including fast approval channel, orphan drugs and priority review of drugs for treatment of rare pediatric diseases It is the eighth new drug to obtain priority approval of drugs for treatment of rare pediatric diseases by FDA Finally, it was approved by the U.S Food and Drug Administration (FDA) on December 23, 2016 Its trade name is spinraza, which is the first FDA approved drug for the treatment of spinal muscular atrophy in children and adults Due to the strategic cooperation between Ionis pharmaceutical company and Baijian, Baijian obtained the global exclusive right to develop, manufacture and commercialize spinraza in 2016 At present, the drug is also listed in the European Union, Japan, Canada, Brazil and other places Since spinraza (nusinersen) went public in 2016, the cost of treatment in the first year of pricing in the United States was $750000, and then $375000 per year The product generated $5 million in sales in the fourth quarter of 2016 In view of the stable growth of spinraza's sales, it has become one of the top products of Baijian Biogen in recent years Photo source: yaozhi.com article [heavyweight] the latest progress in the use of SMA for rare diseases, which will be available in 2019 in China! Due to the demand of domestic patients for spinraza, Novartis and Roche released the notice on Soliciting Opinions on the list of overseas clinical urgent new drugs on August 8, 2018, in which 48 overseas clinical urgent new drugs have been published, spinraza is one of them Subsequently, Kuntai enterprise management (Shanghai) Co., Ltd applied for import NDA of nusinersen according to chemical medicine category 5.1, which was undertaken by CDE on September 5, 2018; later, the application was included in the priority review on December 25, 2018 At present, the approval of the drug will bring good news for spinal muscular atrophy (SMA), and we also hope that the domestic pricing can consider the situation of domestic patients, benefit the public in a reasonable range, and the relevant rare disease supporting policies can take the drug into consideration On February 25th, the application of terdiazolamine phosphate for injection and terdiazolamine phosphate tablets for injection reported by Bayer healthcare showed "approval completed - to be prepared" Tetizolamine phosphate is a new anti bacterial drug developed by cubistpharms On June 20, 2014, it was approved by FDA of the United States for use in adult acute bacterial skin and skin structural infection (absssi) caused by specific sensitive bacteria, and the trade name is sivextro At present, the preparation has not been listed in China On February 22, the application for new drug of rituximab injection declared by Shanghai Fuhong Hanlin biopharmaceutical Co., Ltd was approved for production This drug is the first biosimilar drug approved in China (biosimilar drug refers to the therapeutic biological product with similar quality, safety and effectiveness with the reference drug approved for registration) It is mainly used in the treatment of non-Hodgkin's lymphoma According to the notice of Fosun Group, as of January 2019, Fosun has invested about 453.65 million yuan in R & D of rituximab injection (including indications for non Hodgkin lymphoma and rheumatoid arthritis) Rituximab is jointly developed by Baijian and Roche (including gene Tech in the United States and Chinese and foreign pharmaceutical in Japan) It is the first monoclonal antibody approved by FDA for cancer treatment It was approved by the US Food and Drug Administration (FDA) on November 26, 1997 under the trade name of rituxan The approved indications are non Hodgkin's lymphoma, chronic lymphoblastic leukemia, rheumatoid arthritis, granulomatous vasculitis and microscopic polyangitis According to the sales database of smart drugs, the sales of this drug has been rising slightly from 2011 to 2017, with an average sales volume of 45.8 billion yuan and a sales volume of 52.7 billion yuan in 2017 At present, rituximab injection listed in China (excluding Hong Kong, Macao and Taiwan, the same below) is only used by Shanghai Roche Pharmaceutical Co., Ltd (for non Hodgkin lymphoma indications) According to the latest data of iqviachpa, in 2017, the sales volume of rituximab injection in China was about 1.73 billion yuan On February 22, the class 3.2 new drug sodium bicarbonate ringer injection declared by Jiangsu Hengrui Pharmaceutical Co., Ltd showed "under approval" It is reported that the drug originated from Japan Otsuka Pharmaceutical Co., Ltd and has not been listed in China at present In addition to Hengrui, Sichuan Kelun and China Otsuka pharmaceutical have applied for class 3.2 new drugs Otsuka pharmaceutical has been approved for clinical application, and Sichuan Kelun is currently under review and approval In addition to the application for new drugs, there are four enterprises, namely Sichuan meidakang Jiale Pharmaceutical Co., Ltd., Xi'an Wanlong Pharmaceutical Co., Ltd., Hubei Duorui Pharmaceutical Co., Ltd and China Otsuka Pharmaceutical Co., Ltd., which have applied according to three categories of generic drugs and are under review and approval On February 22, agomeladine tablets of Southwest Synthetic Pharmaceutical Co., Ltd of Peking University international hospital group showed "under approval" Agomeladine was developed by Servier, approved by EMA on February 19, 2009, approved in China on November 28, 2011, and initially listed in Ukraine and China by Servier under the trade name of valdoxan The medicine is suitable for the treatment of severe depression At present, except for imported drugs, only Jiangsu Haosen holds the production approval documents exclusively On February 25, zoelacetan sustained-release tablets, a generic drug, was approved as the first formulation of zoelacetan sustained-release tablets of Shenzhen xinlitai Levetiracetam was developed by UCB and approved by FDA on November 30, 1999 The product name is Keppra It is suitable for partial seizures in patients with epilepsy of 1 month and above, muscle spasm in children of 12 years and above, or primary generalized tonic clonic seizures in patients of 6 years and above At present, the preparation of levetiracetam in China is mainly tablets, with 4 enterprises holding production approval documents and 2 enterprises applying for conformity evaluation, and Zhejiang Jingxin has been evaluated In addition to tablets, there are also oral solution 1 enterprises and concentrated solution for injection 1 enterprises Xinlitai's sustained-release tablets will also be the exclusive dosage form after being approved this time On February 25, the application for listing of four kinds of generic drugs of Aluminum Magnesium Carbonate Chewable Tablets declared by China Resources Shunfeng Pharmaceutical Co., Ltd showed that "approval completed - to be certified" Magnesium aluminum carbonate chewable tablets are used for gastric and duodenal ulcer, acute and chronic gastritis, bile reflux gastritis, esophagitis, and non ulcer dyspepsia (heartburn, acid reflux, heartburn, fullness, early satiety, nausea, vomiting, etc.) At present, a total of 29 domestic enterprises hold production approval documents, while at present, only Chongqing Huasen pharmaceutical has applied for conformity assessment, which has not yet been approved If this time China Resources Shunfeng Pharmaceutical Co., Ltd gets approval first, it will get the market first opportunity This week, CDE accepted 23 new application numbers for production acceptance, including one new drug, which is a freeze-dried group a group C meningococcal conjugate vaccine of three categories of new biological products for prevention of kangxinuo biology; eight generic drugs, three applications according to three categories; in addition, there are 14 imported drugs, as shown in the figure below On February 25, the generic drug application of the drug was accepted by CDE This product is mainly used to relieve moderate and severe acute pain In particular, it can be used to relieve severe pain during operation He spray is mainly developed by Johnson & Johnson company of the United States It was approved by the U.S Food and Drug Administration (FDA) on November 21, 2008 On August 29, 2012, Janssen Pharmaceutical Company in Liden, New Jersey, U.S announced that the U.S Food and Drug Administration (FDA) approved tapentadol to treat adult diabetic peripheral neuropathy (DPN) related neuropathic pain He is the first and only FDA approved opioid drug for DPN related neuropathic pain At present, he spray many related preparations have not been listed in China He also applies for the production of three kinds of generic drugs of Yichang humanwell Pharmaceutical Co., Ltd for hydrochloric acid spray many tablets of chemical drugs At present, it shows that "it has been issued" On February 22, the application for listing of suvoreisen tablets, a chemical 3 generic drug, declared by Tianjin TIANYAO Pharmaceutical Co., Ltd., was accepted by CDE Suvorexant was developed by Merck sharp Dohme (MSD) and approved by the U.S Food and Drug Administration (FDA) on August 13, 2014 After that, suvorexant was approved by Japan's pharmaceutical medical device integration Agency (PMDA) on September 26, 2014 and sold by Merck Its trade name is belsomra Suvorexant is the first orexin receptor antagonist It plays a therapeutic role in the treatment of insomnia through the mechanism of orexin receptor antagonism The drug is suitable for the treatment of insomnia characterized by difficulty in falling asleep and / or maintaining sleep At present, the drug has not been listed in China, only 2 enterprises apply for it, and Dongguan changandong sunshine pharmaceutical research and Development Co., Ltd applies for the clinical application of suvoreisen API class 3.1 new drug, and TIANYAO pharmaceutical industry is the first enterprise applying for listing On February 25, Roche's application for the import of atelizumab injection was accepted by CDE After AstraZeneca durvalumab, atizumab has become the second anti-PD-L1 in China Up to now, four kinds of PD-1 mAbs have been approved in China (two imported and two domestic), and two kinds of PD-1 mAbs and two kinds of PD-L1 mAbs are in the process of market application review and approval Tecentriq (atezolizumab) was developed by Genentech (a subsidiary of Roche) Atezolizumab has been certified by the US FDA as a breakthrough treatment for bladder cancer (2014) and non-small cell lung cancer (2015) Atezolizumab is a humanized monoclonal antibody targeting at PD-L1, which was approved for bladder cancer on May 18, 2016 and became the first approved PD-L1 monoclonal antibody in the world At present, the drug has many other tumor indications in clinical trials Since it was approved for listing in 2016, tecentriq's sales performance has increased in a straight line, with sales of 487 million Swiss francs in 2017 and 772 million Swiss francs in 2018, a year-on-year increase of 58.52% For some information, please refer to: yaozhi.com, Yaozhi global drug R & D database, announcement of relevant enterprises, data source of online public information: yaozhi.com data statement: this opinion only represents the author, not the position of yaozhi.com, and you are welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the article