In the first half of 2019, the number of China's class 1 new drugs, including 57 stone drugs, led the innovation

In the past 2018, more than 100 inds have been accepted and undertaken by the State Drug Administration, setting a new record; in a flash, 2019 has gone through half the way, and 57 varieties of domestic innovative drug class 1 registration application have entered the ind stage, with a strong momentum 1 From the first half of 2019 to the first half of 2019, there are about 57 kinds of inds registered and declared for the first half of 2019 The development situation of innovative varieties is in an overall growth trend, among which the largest number of registered and declared in the first half of the year is January, with 16 varieties entering the ind stage In terms of enterprises, the enterprises with a relatively large number of applications (≥ 4 varieties) are Shiyao, Zhengda Tianqing, and the other enterprises with registration applications are mostly 1-2 varieties entering ind it is worth noting that new drug registration applications are hot in Suzhou, such as Suzhou Zejing, Suzhou Yasheng, Suzhou xinnuowei, Suzhou strategy, Suzhou development, all of which have 1-2 varieties entering ind stage Fig 1: distribution of domestic ind registration and declaration from January to June 2019 2 Shiyao & Zhengda Tianqing (≥ 4 ind varieties) ☆ ~ Shiyao In addition to the star variety of butylphthalide, the antibody drug conjugate ADC (dp303c), humanized gap junction protein 43 monoclonal antibody (almb-0166) and so on all obtained the qualification of orphan drugs issued by the US FDA and launched new drug clinical trials L-amlodipine maleate has applied for NDA in the US, and the strength of new drug development is enough to be proved In China, in the first half of 2019, the follow-up innovation varieties of petrochemicals continued to make efforts to register and apply for 5 inds of class 1 new drugs in China, leading domestic enterprises to apply for new drugs; the 5 varieties were syha1402, syha136, syha1803, syha1807 and syha1801 capsules according to time Attached Fig 2: Central Pharmaceutical Research Institute of Shiyao group ☆ ~ Zhengda Tianqing Zhengda Tianqing, has successfully launched class 1 new drug isoglycyrrhizic acid magnesium injection (Tianqing Ganmei) and class 1 new drug enrotinib, has more than 50 new drug research and innovation projects, won wide praise, and has invested more than 1 billion yuan annually in R & D, which is one of the pharmaceutical enterprises with more investment in the research of innovative drugs in China In China, in the first half of 2019, Zhengda Tianqing registered and declared 4 inds of class 1 new drugs in China, including tqb3562, tqa3563, tqb3804 and tqc3564 Fig 3: the R & D and production base of Zhengda Tianqing innovative drugs 3 The first half of 2019 ~ a brief introduction to some domestic ind varieties For various reasons, most of them will be kept confidential, some of them have not been clinically applied immediately, and the information disclosure will be relatively less Through further inquiry, the following ten varieties of information can be found online for you to learn ☆ ~ tern-101 tern-101, originally developed by Lilly, is a highly effective non bile acid FXR agonist for the treatment of nonalcoholic steatohepatitis In 2018, topaz biology signed a cooperation agreement with Lilly and obtained the global development, production and commercialization rights and interests of tern-101 for the treatment of NASH In April 2019, tuozhen biology published preclinical data at EASL annual meeting of international liver diseases held in Vienna, proving that tern-101 can reduce liver steatosis, inflammation and liver fibrosis in diet induced Nash model of obese mice; in the same month, nmpa accepted the clinical trial application of this product In June 2019, tuozhen biological launched a phase I clinical trial of the fxragonist tern-101 to further support the clinical study of tern-101 in the treatment of NASH ☆ ~ ast-3424 ast-3424 is a first in class anticancer drug jointly developed by AI xindawei and Taiwan Haoding, targeting at overexpression of akr1c3 Under the action of akr1c3, ast-3424 will selectively release strong DNA alkylating agent and start the mechanism of killing cancer cells; this selective starting mechanism makes akr1c3 highly behave in a variety of drug-resistant and refractory cancer cells, such as liver cancer, castration resistant prostate cancer, T-cell acute lymphoid leukemia and other tumor cells Taiwan Haoding is conducting phase I / II clinical study on solid tumor treatment in the United States In July 2018, obi-3424 obtained the FDA orphan drug qualification In April 2019, nmpa accepted the clinical trial application of this product [tsl-0319] tsl-0319 capsule is a dipeptidyl peptidase 4 (DPP-4) inhibitor independently developed by Tianshili By inhibiting the inactivation of glucagon like peptide-1 (GLP-1) and Glucose dependent insulin secretion peptide (GIP), it can promote the release of insulin from the islets of Langerhans, so as to improve the level of islets of Langerhans and reduce blood sugar The drug belongs to class 1 Chemical drug, with full independent intellectual property rights, and is an innovative drug not listed at home and abroad At present, the R & D cost of the project is about 16.9465 million yuan The lh021 lh021 for injection has the potential to repair the damaged cartilage of the knee joint, which belongs to the medicine for improving the condition of the disease From 2015 to 2016, the mechanism research was completed; in May 2016, the project was officially established; in June, the pharmaceutical CMC was started; in December, the domestic patent was applied; in June 2017, the safety assessment research was started; in September 2018, the indpackage was officially completed; in October, the pre indmeeting was held; in January 2019, the mechanism research was officially submitted to ind; in March, the project was officially accepted The idea of clinical trial scheme design will mainly draw on the experience of clinical research of dmoad drugs abroad Referring to the clinical trial experience of similar products at home and abroad, the subjects in the first phase I clinical trial of lh021 will choose the patients with primary knee osteoarthritis who meet the inclusion criteria, rather than the healthy subjects In phase I clinical trial, in addition to the tolerance and pharmacokinetic characteristics of lh021 dose climbing process, the relationship between lh021 dose and efficacy, cartilage synthesis and metabolism related biomarkers will also be explored to provide basis for the formulation of phase II clinical trial drug delivery scheme In the first human clinical trial, single combined multiple dose incremental administration was used to treat primary knee osteoarthritis 28 days after single administration, 28 days after multiple administration and one cycle, 11 weeks in total [ttp273 ttp273 is a non peptide, highly selective glucagon like peptide-1 receptor (GLP-1R) agonist found by vtv company using its small molecule drug development platform It is the first in class of vtv company in the world At present, it has completed phase IIB clinical research in the United States The results show that ttp273 has obvious effect on reducing glycosylated hemoglobin in diabetic patients and has good tolerance The biggest feature and highlight of ttp273 project is that GLP-1 and its analogues are all injection type, while ttp273 product is the first small molecule non peptide oral dosage form China, the United States and East China introduced the ttp273 project in the form of authorization and license, and as a supplement to the company's GLP-1 diabetes product line, it has complementary advantages with the company's existing lilalutide injection under research ☆ ~ 101bhg-d01 101bhg-d01 is a class 1 new drug developed by Beijing shuobai Pharmaceutical Technology Co., Ltd for the treatment of asthma / COPD Beijing shuobai Pharmaceutical Technology Co., Ltd was established in 2016 on the basis of Beijing fengshuowekang Technology Development Co., Ltd (established in 2001) and Beijing jiashilianbo Pharmaceutical Technology Co., Ltd (established in 2007) through financing restructuring The company has 40 R & D teams, with more than 30 years of new drug R & D experience in the core team, which is divided into pharmaceutical department, clinical medicine department, administrative personnel department, intellectual property department and other departments, mainly engaged in innovative drug R & D [lh021 lh021, a class 1 new drug for the treatment of osteoarthritis independently developed by Guangzhou Lingsheng Medical Technology Co., Ltd Founded in 2012, Guangzhou Lingsheng Medical Technology Co., Ltd is engaged in the research and development of new target innovative drugs The company is founded by overseas students and domestic elites in the pharmaceutical industry At present, there are 12 new drug projects in the company's research and development pipeline, covering major chronic disease fields such as oncology, digestive department and aging related specialized diseases [gst-hg151] gst-hg151 is a reversible drug for nonalcoholic fatty liver disease and liver fibrosis developed by Fujian guangshengtang Pharmaceutical Co., Ltd in cooperation with Shanghai yaomingkant new drug development Co., Ltd Preclinical research has shown the effect of improving liver function and remarkable anti fibrosis effect, which is expected to fill the gap in the field of anti fibrosis in the world and overcome the irreversible world problems of liver fibrosis and cirrhosis Lx-039 lx-039 is a new class 1 new drug in the field of breast cancer developed by Shandong Luoxin Pharmaceutical Group Co., Ltd It is a new and effective oral selective estrogen receptor down regulation, which will be mainly used in the treatment of advanced breast cancer At present, there is no oral drug with this mechanism on the market at home and abroad, and similar products are in clinical I / II stage Yps345 yps345 is a class 1 new drug jointly developed by Tianfang Pharmaceutical Co., Ltd and Institute of Biophysics, Chinese Academy of Sciences to be used in the treatment of pneumonia and pulmonary fibrosis caused by chest radiotherapy for cancer patients At present, there is no same product in the market In the non clinical trial research stage of yps345, the effectiveness and safety research results of Tianfang pharmaceutical show that as a drug to prevent and treat radiation inflammation, it can significantly alleviate the pulmonary fibrosis induced by radiotherapy and chemotherapy in animal models, and has good safety [cs3003 cs3003, a selective inhibitor of HDAC6 developed for cornerstone pharmaceutical industry, can be used as a single drug treatment or combined with conventional standard therapy, and has the potential to show better efficacy in multiple myeloma The preclinical data and preclinical and early clinical studies of similar products also found that cs3003 may have better safety than broad-spectrum HDAC inhibitors, as well as the potential to develop the combination therapy with immunocheckpoint inhibitors in different indications Asc21 asc21, developed by Geli Pharmaceutical Co., Ltd., is a nucleotide inhibitor combined with NS5B polymerase, which can prevent chronic hepatitis C virus infection by inhibiting the activity of NS5B polymerase Preclinical studies show that asc21 is an effective pan genotype drug with high resistance gene barrier GOLLY plans to use it in combination with ravidavir to treat patients with refractory, cirrhosis and HCV / HIV co infection Attached table: ind data of class 1 new drugs in China from January to June 2019 (based on the first undertaking date of varieties, statistical time: June 30, 2019) data source: drug intelligence data; acceptance announcement; official websites of major companies; official websites of securities companies.