2019 domestic class 1 new drug IND ranking! Zhengda sunny, stone medicine, East Sunshine, Hengrui...

In 2019, the development of innovative drugs is still hot, the number of domestic class 1 new drug IND continues to exceed 110, and then a new high; Zhengda Sunny 8 inD by the National CDE acceptance, ranked first of all domestic pharmaceutical enterprises, followed by Stone Pharmaceutical Group, Guangdong East Sunshine, Jiangsu Hengrui, etc.;
1. 2019: Domestic class 1 new drug IND overall situation 2019 full year, domestic 1 new drug (chemical) registered declaration of IND varieties 110 (nearly 100 in 2018), the overall development situation of innovative varieties is in a growing trend.
, the largest number of annual registration declarations in January, a total of 16 varieties into the IND stage, the minimum month is September, domestic class 1 new drug IND only 1 variety (PS: to reflect the domestic class 1 new drug innovative water products, foreign enterprises registered to declare imported IND is not included in the statistics).

. 2019 full year: domestic class 1 new drug IND enterprise analysis enterprise, the number of IND declaration sits relatively more for the positive day, a total of 8 pieces, varieties are TQB3562 tablets, TQA3563 tablets, TQB3804 tablets, TQC35 64 tablets, TQB3303 tablets, TQB3602 capsules, TQB3473 tablets, TQB3728 tablets;
followed by Shipharmaceutical Group Zhongqi Pharmaceuticals (5), Guangdong Dongsun (4), Jiangsu Hengrui (4), Suzhou Xinnovi (3 pieces);

. 3. 2019 full year: domestic part of the IND varieties analysis of new drug IND stage varieties, due to various reasons, the disclosure of information is often not much, through inquiries, part of the IND varieties information as follows, in reverse order.
CS3002, developed by Keystone Pharmaceuticals, is a CDK4/6 selective inhibitor that inhibits the activity of CDK4/6 kinase by specificy, in order to inhibit tumor growth.
preclinical studies show that CS3002 has the same inviviable and external activity as palbociclib, and in mouse animal models, combined PD-1 monotonicaors or endocrine therapy showed good inhibition of tumor growth, and combined therapy was superior to monodrug therapy;
PS: Has received an ethical licence for clinical trials issued by the Australian Commission on Human Research Ethics.
ABSK011 developed by Shanghai and Yu Biopharmaceutical Technology Co., Ltd., for the company's independent independent research and development of small molecule oral FGFR4 inhibitors, its excellent activity, selectivity and other physical and chemical properties indicate that the drug has the potential to become a global best-in-class, the clinical development of the drug will further broaden and reputation medicine in the field of tumor treatment layout.
PS: Has been approved for clinical trials by the Taiwan Food and Drug Administration, will soon conduct a clinical phase 1 study on hepatocellular carcinoma.
GST-HG131, developed by Fujian Guangshengtang Pharmaceutical Co., Ltd., is a global innovation drug for the treatment of hepatitis B with global intellectual property rights, is a global leader in First-in Class, has the opportunity to become the world's first listed hepatitis B HBsAg inhibitor innovation drug, is the company's hepatitis B functional cure "peak plan" one of the important combination programs.
GST-HG131 core compound has been filed for PCT international patent and its Chinese patent has been granted a notice of authorization.
BPI-27336, a new molecular entity compound with fully independent intellectual property rights developed by Beida Pharmaceuticals, is a new type of powerful, selective extracellular regulatory kinase 1/2 (ERK1/2) oral small molecule inhibitor, intended for THE treatment of RAS/RAF/MEK-activated mutation of colorectal cancer, pancreatic cancer, lung cancer, liver cancer, stomach cancer, melanoma and other solid tumors.
as of the date of disclosure, there are no ERK1/2 inhibitors listed in the world, and a number of ERK1/2 inhibitors abroad are in clinical research.
HH2710 is an efficient, specific small molecule ERK kinase inhibitor developed by Shanghai Haihe Pharmaceuticals in collaboration with the Shanghai Institute of Pharmaceutical Research of the Chinese Academy of Sciences. Early non-clinical studies of
showed that hH2710 had excellent in vitro antitumor activity, pharmacokinetic properties and safety performance, and in CDX model, the in vivo antitumor activity of HH2710 was significantly better than similar compounds at the same dose.
and in September 2019, it has been approved by the U.S. FDA for clinical trials to treat malignant tumors that have been tested and confirmed to have genetic abnormalities in the MAPK signaling pathway.
KC1036 KC1036 is an innovative chemical type 1, which has not been listed at home and abroad independently developed by Kangchen Pharmaceuticals, and is intended for the treatment of solid and blood tumors.
is a multi-target tyrosine kinase inhibitor, and preclinical results show that KC1036 kinase activity is strong, showing significant tumor suppression activity in animal models of a variety of solid tumors and blood tumors, and has good safety.
Kangchen Pharmaceuticals said that as of the announcement date, the company invested about 22.77 million yuan in research and development costs on the KC1036 project.
ORIN1001 ORIN1001 is a pioneering small molecule drug (First-in-Class) with new enzyme targets, new mechanisms and new chemical structure types developed by Fosun Pharmaceuticals subsidiary Fosun Hongtron to treat advanced solid tumors, the first of which is to explore the adaptive disease for recurrent, refractive, metastatic breast cancer.
As of May 2019, Fosun Pharma Group has invested approximately 45.47 million yuan in research and development for the new drug.
and the FDA has granted its new drug ORIN1001 fast-track eligibility for the treatment of recurrent, refractive, metastatic breast cancers, including triciacyl breast cancer.
FCN-647 Fosun Pharmaceutical Holdings subsidiary Chongqing Fucheng Pharmaceutical Research Co., Ltd. developed to treat recurrent or incurable B lymphocyte malignancies, as of September 2019, the Group's cumulative research and development investment for the new drug at this stage is about 23.68 million yuan (unaudited).
global sales of drugs that are targeted at the same target for the new drug are about $4.51 billion, according to IQVIA.
HSK21542 was developed by Hyscoe to provide a new type of analgesic drug with proprietary intellectual property rights for the treatment of acute and chronic pain, classified as a chemical class 1.
according to preclinical research, HSK21542 is a selective agonist of peripheral kappa opioid receptors, with strong and long-lasting analgesic effect, not easy to pass through the blood-brain barrier, in the play of peripheral analgesics at the same time, can avoid central opioid-related side effects, such as addiction, hallucinogens, respiratory inhibition and so on.
these characteristics show that HSK21542 has significant efficacy, good safety and other obvious clinical advantages, can provide a large number of patients with acute and chronic pain to provide better drug options.
so far, the company has invested about 20 million yuan in research and development of HSK21542 injections.
SH2442, independently developed by Nanjing Sanhe Pharmaceutical Co., Ltd., is a small molecular inhibitor of acetyl coenzyme A cariumase, the first declared target innovation drug for the treatment of non-alcoholic fatty hepatitis (NASH) and its resulting liver fibrosis, with benostle compounds, synthesis processes, preparations, uses of global intellectual property rights.
TY-302, developed by Zhengzhou Teki Hongno Pharmaceutical Co., Ltd., has fully independent intellectual property rights, is a powerful, highly selective oral cell cycle protein-dependent kinase 4/6 (CDK4/6) inhibitor, used in hormone receptor-positive and epidermal growth factor receptor 2 negative (HR/HER2-) local advanced or metastatic breast cancer and other advanced solid tumors or blood system tumor treatment.
since October 2019, two new anti-lung cancer drugs and anti-breast cancer drugs developed by the company have been approved for clinical trials.
GST-HG141 Fujian Guangshengtang Pharmaceutical Co., Ltd. after four years to complete the GST-HG141 application for clinical trials of all the data and complete sets of information, in August 2019 received the State Drug Administration issued the "receiving notice", the company's hepatitis B treatment of the global innovative drug hepatitis B core protein inhibitor GST-HG141 clinical application received, the application stage "clinical."
the project is one of the most important constituent drugs of Guangshengtang's "Peak Project" for the functional cure of hepatitis B under the guidance of many basic research scientists, and is the result of research and development in cooperation with Shanghai Pharmaceutical Mingkang New Drug Development Co., Ltd., which has the leading research and development strength of new drug research and development, and there is currently no global market for this target drug, which is expected to become the Best-in-class project.
goal: Challenge the functional cure of hepatitis B.
GST-HG141 core compound has been filed for PCT international patent, plans to enter China, the United States, Japan, Europe and other 24 countries and regions.
HTD1801 HTD1801, developed by Shenzhen Junsanti Ai Bio, fda has awarded its research small molecule innovation drug HTD1801 for the treatment of non-alcoholic fatty hepatitis (NASH) fast-track review qualification. Prior to
, the FDA also awarded HTD1801 the eligibility and fast-track review qualification for orphan drugs for the treatment of primary sclerosing choline (PSC).
currently, Phase II clinical trials for THE treatment of PSC in HTD1801 are under way in the United States, and the Phase II study program for the treatment of NASH will soon begin patient recruitment in the United States.
TY-9591 Homologous Pharmaceuticals, the first national class 1 anti-tumor targeted drug to enter clinical trials, the third representing a dermal growth factor receptor (EGFR) inhibitor, and a patent for the invention of the compound, oichtinib.
DN1508052-01 Shanghai Dino Pharmaceutical development, an efficient small molecule TLR8 agonisant (the first TLR8 agonisant submitted to IND in China), intended for immunotherapy for cancer.
November 2018, Shanghai Dino Pharmaceuticals received a letter from the FDA that has completed the DN1508052-01 New Drug Clinical Research Application Application (IND).
in late May 2019, Shanghai Dino Pharmaceuticals launched an open, multi-center Phase I clinical trial to recruit 25 subjects to initially evaluate the safe tolerance, metabolic dynamics and antitumor activity of DN1508052-01 monocutaneous injections for patients with solid tumors.
JAB-3312 JAB-3312 can block the KRAS-MAPK signaling pathway for the treatment of non-small cell lung cancer, colorectal cancer, pancreatic cancer and other solid tumors, but also can lift the tumor immunosuppressive microenvironment, enhance the efficacy of existing tumor immunotherapy.
July 3, 2019, Gacoste's self-developed small molecule oral JAB-3312 was approved by the FDA for clinical trials of new drugs, the second small molecule cancer drug to enter clinical practice after JAB-3068 entered the clinical IIa phase.
Fumaacid Obitine Fumatide, developed by Zhongnan University and Shenzhen Jinxing Pharmaceutical Technology Co., Ltd., can specifically activate tumor cell apoptosis signal transduction pathway key enzyme origin - cystic winter protease-3 enzyme, it is activated into tumor apoptosis key implementation molecule cystic cystic ophthalase-3, resulting in rapid tumor cell death.
clinical indications are mainly non-small cell lung cancer.
TERN-201 TERN-201, originally developed by Eli Lilly.
2018, Tudor Bio signed a global exclusive agreement with Lilly to develop, manufacture and commercialize TERN-201 therapeutic NASH.
at the International Liver Congress in Vienna in the first half of 2019, Tudor Bio published tern-201 preclinical research data showing significant improvements in liver NAS scoring and fibrosis in the NASH rodent model.
The Company recently acquired exclusive rights from GENFIT to develop, manufacture and commercialize PPAR alpha/ethtic adagonalor for the treatment of non-alcoholic fatty hepatitis (NASH) and primary bile bile ductitis (PBC).
The results of pre-clinical trials in Elafibranor show positive results for both NASH and PBC indications and are likely to be an important part of future combination therapies.
AST-3424 AST-3424 is a first-in-class cancer drug developed jointly by AisinDawe and Taiwan's Haoding.
AST-3424 under the action of AKR1C3, will selectively release strong DNA alkylification agent, start the mechanism of annihilation of cancer cells, this selective activation mechanism, so that AKR1C3 in a variety of drug resistance and difficult to treat cancer, such as liver cancer, de-aggressive prostate cancer, T-cell acute lymphocytic leukemia and other tumor cells, are highly demonstrated.
Taiwan Hoding is in the United States to treat solid tumorclinical Phase I/II studies.
July 2018, OBI-3424 was eligible for FDA Orphan Medicine.
April 2019, NMPA accepts applications for clinical trials of this product.
TSL-0319 TSL-0319 capsule is a dipeptide peptide enzyme 4 (DPP-4) inhibitor developed by Tianshi, which promotes insulin release by the islet by inhibiting the inactivation of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulin secretion peptides (GIP) to promote the release of insulin in the islet, thereby increasing insulin levels and thus reducing blood sugar.
the drug belongs to class 1 chemical drug, has full independent intellectual property rights, belongs to the domestic and foreign are not listed in the innovative drug.
the item.