In the first half of 2019, Hengrui's carrilizumab, GSK's belimuzumab, Hausen's polyethylene glycol losenatide injection, Pfizer's dacrotinib, Eli Lilly's barretinib...Innovative drugs have been approved one after another. There are also predictions for innovative drugs that are expected to be approved in the second half of 2019. So what major generic drugs will be approved for marketing in China in the second half of 2019?
Insight database screened 9 first generic drugs that are expected to be approved in 2019, namely
- Jiangsu Hengrui Celecoxib Capsules
- Jiangsu Hengrui Estek hydrochloride injection
- Zhengdatianqing bendamustine
- Zhengdatianqing Pomalidomide capsule
- Zhengdatianqing polymyxin for injection E Sodium methanesulfonate
- Zhengdatianqing Dabigatun ester capsule
- Zhengdatianqing's injection azacitidine
- Dongyangguang Pharmaceutical's linagliptin tablets
- Dongyangguang Pharmaceutical's Entacapone tablets
Jiangsu Hengrui Celecoxib capsules
Original research manufacturer: Pfizer
Competitive first imitation companies: Shiyao Ouyi, Zhengda Qingjiang, Qingdao Baiyang
celecoxib is a selective inhibition COX-2 Nonsteroidal anti-inflammatory drugs are mainly used to relieve the symptoms and signs of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in humans, as well as to treat acute pain in adults.
celecoxib was developed by GD Searle and was first approved for marketing in the United States in 1998. The product name is CELEBREX. Currently, it has been approved for listing in many EU countries and Japan. In 2016, the product's global sales were approximately US$960 million, while in China's sales were approximately US$64.599 million. In 2016, the product's global sales were approximately US$960 million, while in China's sales were approximately US$64.599 million.
Insight database query shows that currently, imported celecoxib capsules from GDSearle and Pfizer companies are on the market in China, as well as celecoxib raw materials from Jiangsu Zhengda Qingjiang Pharmaceutical Co., Ltd., Jiangsu Shengdi Pharmaceutical Co., Ltd. and Pfizer companies are approved, and no domestic celecoxib preparations are on the market.
This product is very competitive. Currently, 10 pharmaceutical companies have applied for listing. The fastest-progressing is Jiangsu Hengrui Pharmaceutical Co., Ltd., which is currently in the third round of supplementary information queues for review.
Jiangsu Hengrui Estketamine Hydrochloride Injection
Original manufacturer: Johnson & Johnson
Other first-competitive imitation companies: No
Estketamine Hydrochloride is a chiral cyclohexanone derivative with analgesic effects and anesthesia caused by increased doses. It can be used to treat surgical analgesic sedation and major depression. In 2017, global sales of esketamine hydrochloride injection were approximately US$12 million.
At present, only Jiangsu Hengrui Daily was listed in China. It was hosted by CDE on June 7, 2018 and included in the priority review and approval list. As of August 2018, Hengrui has invested approximately RMB 18.67 million in the R&D project.
Currently, Hengrui This variety has completed on-site inspection of clinical trials and is in the first round of supplementary information under review. It is expected to be approved in Q4 2019.
Zhengda Tianqing Bendamustine Hydrochloride
Original research manufacturer: Cephalon Company
Other first-competitive imitation companies: Xiansheng Dongyuan, Sichuan Huiyu
bendamustine is a bifunctional alkylating agent that cross-links DNA single-strand and double-strands through alkylation, interferes with the function of DNA and the synthesis of DNA, thereby exerting an anti-tumor effect.
This drug can be used to treat various malignant tumors such as Hodgkin's disease, non-Hodgkin's lymphoma (NHL), multiple myeloma , chronic lymphocytic leukemia (CLL), and breast cancer. It can significantly reduce recurrence and mortality, have small adverse reactions and high safety. Global sales peaked at $767 million in 2014.
Nanjing Xiansheng Dongyuan and Zhengda Tianqing submitted their marketing applications for bendamistine hydrochloride for injection on June 20, 2013 and September 27, 2013, respectively, but were withdrawn in the 722 clinical self-examination.
In January 2017, Xiansheng Dongyuan and Zhengda Tianqing submitted their listing applications again, among which Xiansheng Dongyuan applied for CLL indications and Zhengda Tianqing applied for NHL indications. All of them were later included in the priority review by the CDE.At present, Zhengda Tianqing is progressing rapidly and is in the third round of supplementary review. There has been no progress since the second round of supplementary releases in August 2018.
Competition status of various companies is as follows:
Picture source: Insight Database
ZhengdatianqingPomalidomide Capsules
Original manufacturer: Xinji Pharmaceutical
Other competition first imitation company: No
Pomalidomide is a thalidomide analog, an immunomodulator, has anti-tumor activity, can inhibit the proliferation of hematologic cells and induce cell apoptosis. On January 8, 2013, the U.S. FDA approved pomalidomide for patients with multiple myeloma whose condition still progressed after treatment with other anti-cancer drugs.
Multiple myeloma is a hematologic malignant tumor commonly found in middle-aged and elderly people. Its incidence rate has exceeded acute leukemia in many countries, ranking second among hematologic malignant tumors. Although many
pomalidomide capsules have applied for clinical trials, only Zhengda Tianqing has submitted an application for marketing, 3 are in clinical trials, and 14 are in approved clinical states.
Competition situation of various companies is as follows:
Picture source: Insight database
Currently, this variety is in the on-site inspection stage of clinical trials.
Zhengdatianqing Polymyxin E Sodium methanesulfonate
Other first-competitive imitation companies: Aosaikang Pharmaceutical
polymyxin E Sodium methanesulfonate is the first choice for the treatment of infection caused by Gram-negative bacteria such as multidrug-resistant Pseudomonas aeruginosa, and will not produce cross-resistance with other antibiotics or antibacterial drugs. It is a super antibiotic urgently needed by domestic patients with acute and severe illness.
On December 7, 2017, the sodium polymyxin E methanesulfonate for injection submitted by Zhengda Tianqing was undertaken by CDE and included in the priority review and approval list. Clinical trial verification has been completed.
Competition status of various companies is as follows:
Picture source: Insight database
Currently, this variety is in a state of replenishment and has completed on-site inspection of clinical trials.
Zhengdatianqing Dabigatran ester capsule
Original manufacturer: Boehringer Ingelheim Pharmaceutical
Other first-competitive imitation companies: Chengdu Betel, Hausen
DABIGANT ester, the trade name is Pradaxa, is a prodrug of Dabigatran, which is converted into a coagulation activity dabigatran by enzymatic hydrolysis in the body. The latter exerts an anticoagulant effect by directly inhibiting thrombin.
Dabigatran methanesulfonate capsules were approved for listing by EMA in March 2008. The original research company was Boehringer Ingelheim, and it was approved by the FDA in 2010. With its precise efficacy and better safety advantages, Pradaxa has entered the ranks of blockbuster drugs in its global sales exceeding US$1.4 billion in the third year after its launch.
On August 15, 2018, Zhengda Tianqing submitted an application for the launch of its 4-class generic drug for Dabigatun Ester Capsules, and has been accepted and undertaken by the CDE and is expected to become the first imitation of this blockbuster drug.
There are also many pharmaceutical companies in China that have developed generic drugs for dabigatran methanesulfonate capsules. Pharmaceutical companies that have been approved for clinical practice include Chengdu Yuandong, Shaanxi Buchang Hi-Tech Pharmaceutical, Guizhou Yibai Pharmaceutical, Qilu Pharmaceutical (Hainan), etc.
Competition status of various companies is as follows:
Image source: Insight database
Currently sunny This variety is in a state of replenishment.
Zhengdatianqing Azacitidine for injection
Original research manufacturer: Xinji Pharmaceutical
Other first-competitive imitation companies: Shanghai Huilun, Sichuan Huiyu
Azacitidine for injection, trade name: Vidasha, is a nucleoside metabolism inhibitor, which has been approved in China to treat medium-risk-2/high-risk myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) and chronic myeloid leukemia (CMML) with 20-30% bone marrow blast cells.
Vidasha is recommended as a first-line treatment medication by the National Comprehensive Cancer Network Guidelines.In February 2018, BeiGene said it had obtained the exclusive distributor right granted by Celgene to exclusively sell the drug in China.
Azacitidine for injection submitted by Zhengda Tianqing on May 15, 2017 was undertaken by the CDE and was later included in the priority review and approval list. Supplementary data review has been completed and will be launched soon.
Competition status of various companies is as follows:
Picture source: Insight database
Currently, the variety is in the third round of replenishment.
Dongyangguang Pharmaceutical linagliptin tablets
Original manufacturer: Boehringer Ingelheim Pharmaceuticals, Eli Lilly
Other first-competitive imitation companies: There is no
linagliptin. In May 2011, the US FDA approved the listing and was jointly sold by Boehringer Ingelheim and Eli Lilly. In March 2013, the CFDA approved the import registration of linagliptin, under the trade name O'Downing, which is mainly used to treat type 2 diabetes.
On July 4, 2018, the linagliptin metformin tablets submitted by Guangdong Dongyangguang Pharmaceutical were under the CDE, and the company's linagliptin tablets were also under the CDE on the 20th of the same month. Both were included in the priority review and approval. According to statistics from the database, there are currently 11 applications for linagliptin tablets that CDE has accepted, of which 9 domestic generic drugs such as Zhengda Tianqing and Chenxin Pharmaceutical have been approved for clinical approval. Qilu and Yangzijiang Pharmaceutical are in clinical trials, and only Dongyangguang has submitted an application for marketing.
Competition situation of various enterprises is as follows:
Picture source: Insight database
Currently, Dongyangguang This variety is in the first round of supplementary review.
Dongyangguang Pharmaceutical Enta Capone Tablets
Original research manufacturer: Finland Orion Group, Novartis
Other first-competitive imitation companies: There is no
Enta Capone Tablets, the product name Kedan, is a specific peripheral catecholamine-o-methyltransferase inhibitor (comti), which can be used as an auxiliary drug for the standard drug levodopa/benserazine or levodopa/carbidopa, and is used to treat Parkinson's disease and the dosage phenomenon (symptom fluctuations) that the above drugs cannot control.
Insight Database statistics show that there are currently 3 applications for enta capone films accepted by CDE, and only Dongyangguang has submitted a listing application. On August 29, 2018, Enta Capone tablets from Guangdong Dongyangguang Pharmaceutical were undertaken by CDE and included in the priority review and approval.
Competition situation of various enterprises is as follows:
Picture source: Insight database
Currently, Dongyangguang This variety is in the first round of supplementary review.
Source: Insight database
Orchestration: Li Xin
