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| Another domestic drug sold to us domestic drug companies went abroad |
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| Author：中国铭铉 企划部 Release Time：2017-9-22 9:55:11 Number Browse：1395 |
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Medical network on September 22 - on September 20, jiangsu hengrui pharmaceutical co., LTD., announced that specifications for 200 mu g/ml of hydrochloric acid right beauty holds 2 microphones injection by FDA drug evaluation and research center of abbreviated new drug applications (ANDA), jiangsu hengrui pharmaceutical co., LTD. Can production and sales of hydrochloric acid to the American public right beautiful mi set injection.
Another Chinese medicine ▍ sold to the United States
Right beauty microphones set is a relatively selective alpha 2 receptor excited medicine, have a calming, anti-anxiety, hypnosis, pain, and sympathetic nerve block, 1999 by the us food and drug administration (FDA) approved for use in adult intensive care unit (ICU) patients with mechanical ventilation short-term calm.
At present, the United States and European countries have begun to use dexmetomidine hydrochloride to be used outside the ICU, including neurosurgery, pediatric, cardiovascular surgical fiberoptic bronchoscopy and the treatment of obesity surgery.
At present, there are four pharmaceutical companies in China which have the approval of dexmetomidine hydrochloride injection, which is the first copy of hengrui pharmaceutical co., LTD. The production of dexmetomidine hydrochloride injection has been widely used in clinical anesthesia and severe cases since it was listed in 2009.
The approval of the FDA's drug review and research center's brief new drug application means that Mr. Henryl's HCL, dexmetomidine hydrochloride, is eligible for sale in the United States. Why is that?
With the advent of the patent cliff for biological drugs, the rise of the generic drug industry will be overwhelming. It also means that the pharmaceutical approval department will face huge generics approval pressure. So, on October 10, 2015, the FDA announced that it would adjust its new approval system for new drugs, which would require generics makers to go through the approval process without submitting the final print label.
Generic drugs are comparable to original drugs in dosage forms, dosage, methods of taking, quality, performance characteristics and application methods. Generic applications are called "thumbnail applications" because they do not require pre-clinical data (animal experiments) and clinical data (human trials) to establish the effectiveness of safety. Once approved, the applicant can produce and sell the generic drug to provide safe, effective, and inexpensive alternatives to the American public.
▍ domestic drug firms are abroad
As the world's more than $100 billion patent medicine is about to expire, the strength of Chinese pharmaceutical companies' participation in global competition is significantly enhanced and the historic opportunity to promote the "going out" of pharmaceutical companies in China is being formed. In addition, the state has paid more and more attention to the research and development of innovative drugs. Many pharmaceutical companies have joined the r&d team of innovative drugs, and it is increasingly common for overseas clinical studies to apply for innovative drugs.
In FDA drug declare China many enterprises, including tasly salvia miltiorrhiza dropping pill, li li injection, green leaves:, modern righting blood and kang pharmaceutical of cassia twig tuckahoe capsule, etc. But it took almost 10 years for these products to come today.
However, for traditional Chinese medicine enterprises, it is easier to go abroad. So far, a number of generic drug companies in China have received the FDA's new drug application.
Previously, Michael R at the FDA's drug evaluation and research center. Dr HAMRELLA said that innovative drugs from Chinese pharmaceutical companies could be easily passed by the FDA than generic drugs. In the past for many years, the Chinese market of drugs to generic drugs and foreign existing do change the products, so on the review of examination and approval of generic drugs on FDA may be required to have higher technology. Innovative medicine has more space in the international market, especially as the innovation ability of Chinese pharmaceutical enterprises is constantly improving. It is an inevitable trend to enter the European and American market.
▍ in recent years, some drug firms abroad overview:
Dongguang pharmaceuticals: iphineone
On February 22, the anti-fibrosis 1 new drug in the east sunshine pharmaceutical company (HEC585) received FDA approval to enter the phase I clinic. On May 4, the company announced that it had successfully initiated and successfully completed the first dose of 2 subjects in the clinical trial center of covins (USA) phase I on 2 May 2017.
Corning jerry: KN035 recombinant humanized pd-l1 single-domain antibody Fc fusion protein injection
On November 29, 2016, suzhou corning jerry biological technology co., LTD., announced that the company independent intellectual property rights category drugs - KN035 recombinant humanized PD - L1 single domain antibodies injection by the FDA's review of the Fc fusion protein, allowed to conduct clinical research in the United States.
Yaxin medicine: apg-1252
On December 22, 2016, yaxin medicine announced that the company's anti-tumor drug apg-1252, acting on the new target bcl-2 family protein, was approved by the FDA for clinical trials. The proposed indications are solid tumors including small cell lung cancer (SCLC).
Rehom Hamlin: HLX07
On October 13, 2016, honglin issued an announcement that Henlix, a holding subsidiary, received a letter from the FDA about the clinical trial of the approval of HLX07 injection. HLX07 is a monoclonal antibody modified to improve the treatment of multiple solid cancers such as colorectal cancer.
Eisen medicine: AC0058
In February 2016, the AC0058 of eisen 1.1 class of innovative drugs was approved for phase I clinic in the United States. AC0058 through specific inhibition of B lymphocyte and other key regulators of inflammatory cells in molecular bruton tyrosine kinase (BTK), can be used in the treatment of systemic lupus erythematosus (sle) and autoimmune diseases such as rheumatoid arthritis. As early as September 2014, eisen's third-generation EGFR targeting inhibitor ivitinib was approved by the us FDA for clinical research.
Baiji shenzhou: BGB series
BGB- 3111, BTK inhibitor of baiji shenzhou, was approved by the FDA in June 2015, and is currently in phase III clinical treatment for huagin macroglobulinemia. Pd-1 anti-bgb-a317 was reviewed in January 2016 through FDA new drug research application (IND).
Kanghong pharmaceutical: compaq
On October 10, 2016, yasuhiro miyata announcement said the company the FDA granted compaq heap eye ophthalmic injection in the United States to wet age-related macular degeneration (wAMD) phase III clinical trials, is the first class of biological phase III clinical drug directly into the United States.
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