Clinical Trends of China's Class 1 New Drugs in May 2020

In May 2020, a total of 19 Chinese class 1 chemical drugs were approved by the State Drug Administration (NMPA) for clinical trials, the specific information is shown in the table below:
data sources: Pharmaceutical Spyu Database
01,
SPH4336
SPH-4336 developed by Shanghai Pharmaceuticals, in the clinical phase of the treatment of advanced solid tumors.
research and development milestone
on March 31, 2020, the ind application for the drug was undertaken by the State Drug Administration (NMPA) as a generics class. In May 2020, the drug was implicitly licensed by NMPA clinical trials for advanced solid tumors (including but not limited to breast cancer, central neuropathic tumors/metastatic tumors, etc.).
02,
. SYHA1805 tablets
SYHA-1805 developed by Shijiazhuang Group Zhongqi Pharmaceuticals and are in the clinical phase of the treatment of non-alcoholic fatty hepatitis (NASH).
research and development milestone
on March 4, 2020, the drug's IND application was sponsored by the State Drug Administration (NMPA) as a generics class. In May 2020, the drug was implicitly licensed in clinical trials of NMPA for the treatment of non-alcoholic fatty hepatitis (NASH).
03,
. TG-1000 capsules
TG-1000 developed by Taijing Pharmaceutical Research and Development (Beijing) Co., Ltd., in the clinical phase of the treatment of influenza.
research and development milestones
March 13, 2020, the drug's IND application was sponsored by the State Drug Administration (NMPA) as a chemical drug class. In May 2020, the drug was implicitly licensed by NMPA clinical trials to treat influenza A and B in adults.
04,
. HS-10356
HS-10356 was jointly developed by Jiangsu Haussen Pharmaceuticals and Shanghai Hansen and is in the clinical phase of the treatment of non-alcoholic fatty hepatitis (NASH).
research and development milestone
March 24, 2020, the drug's IND application was undertaken by the State Drug Administration (NMPA) as a generic syd. In May 2020, the drug was implicitly approved by nMPA clinical trials and initially developed for the treatment of non-alcoholic fatty hepatitis (NASH).
05,
. PG-011 gel
PG-011 developed by Beijing Pujuan Pharmaceuticals, in the clinical phase of the treatment of specific dermatitis.
research and development milestone
february 29, 2020, the drug's IND application was sponsored by the State Drug Administration (NMPA) as a chemical drug class. In May 2020, the drug was implicitly licensed by NMPA clinical trials to treat adhesion dermatitis.
06,
toluene sulfonate ningtini capsule
toluene sulfonate ningtinib is a multi-target inhibitor developed by Guangdong East Sunshine, intended to treat cancer, including lung cancer, stomach cancer, bowel cancer, FLT3 gene mutation-positive recurrence / difficult treatment of acute myeloid leukemia, EGFR TKI treatment after drug resistance T790M mutation negative IIIB IV iv cell or non-small lung cancer.
research and development milestone
on March 11, 2020, the drug's IND application was undertaken by the State Drug Administration (NMPA) as a chemical drug class. In May 2020, the drug was implicitly licensed by NMPA clinical trials to treat a variety of solid and blood system tumors in combination with KN046.
February 2013, Guangdong Dongsun Pharmaceutical Co., Ltd. submitted a clinical trial application (Chemical Drug Class 1) in China, and obtained a clinical trial approval on October 17, 2013.
07,
. ICP-723
ICP-723 is an NTRK inhibitor developed by Novartis and is in the clinical phase of the treatment of NTRK fusion-positive cancer.
research and development milestone
on March 17, 2020, the ind application for the drug was undertaken by the State Drug Administration (NMPA) as a generic saline. In May 2020, the drug was implicitly licensed by NMPA clinical trials to be used to treat advanced or metastatic solid tumors carrying NTRK fusion genes.
08,
. ZN-A-1041 enterolytic capsules
ZN-A-1041 developed by Suzhou Zanrong Pharmaceutical Technology, in the treatment of HER2-positive late-stage solid tumor clinical phase.
research and development milestones
March 13, 2020, the drug's IND application was sponsored by the State Drug Administration (NMPA) as a chemical drug class. In May 2020, the drug was implicitly licensed by NMPA clinical trials to treat HER2-positive advanced solid tumors.
09,
. XTR003 injection
XTR-003 was developed by Pioneer Medicine and is in the clinical phase of diagnosis and evaluation of myocardial activity.
research and development milestone
on March 19, 2020, the drug's IND application was undertaken by the State Drug Administration (NMPA) as a chemical drug class. In May 2020, the drug was implicitly licensed by the NMPA clinical trial for the diagnosis and evaluation of myocardial activity using the metabolic characteristics of fatty acids in the heart muscle.
10,
. HS-10352
HS-10352 developed by Jiangsu Haussen Pharmaceuticals, is in the clinical phase of breast cancer treatment.
Research and Development Milestone
on March 10, 2020, the ind application for the drug was sponsored by the State Drug Administration (NMPA) as a chemical drug class. In May 2020, the drug was implicitly approved by NMPA clinical trials to treat advanced breast cancer with phosphatidyl inositol inositol 3 kinase alpha-type mutation-positive (PIK3CA-) hormone receptor-positive (HR-plus) human epidermal growth factor receptor 2 negative (HER2-).
11,
. ASC41 capsule
developed by Golichina, ASC-41 is a thyroid hormone beta receptor agonist in clinical phase research in the treatment of non-alcoholic fatty hepatitis.
research and development milestone
February 21, 2020, the drug's IND application was organized by the State Drug Administration, as a chemical drug class. In May 2020, the drug was clinically impliedly licensed by NMPA for the treatment of non-alcoholic fatty hepatitis.
12,
. HSK21542 Injection
HSK-21542 developed by Hexco Pharmaceutical Group Co., Ltd. and wholly-owned subsidiaries Sichuan Haicisco Pharmaceutical Co., Ltd., Liaoning Haicisco Pharmaceutical Co., Ltd., is a selective agonist for peripheral kappa opioid receptors, is in the clinical second phase of the treatment of acute and chronic pain, and is in the clinical phase i-phase study of the treatment of itching.
research and development milestones
February 28, 2020, the drug's IND application was undertaken by the State Drug Administration (NMPA) as a chemical drug class. In May 2020, the drug was granted clinical incurt approval by NMPA for the treatment of itching.
October 24, 2019, the drug's IND application was sponsored by the State Drug Administration (NMPA) as a generics class. In December 2019, the drug was granted clinical incuratic approval by NMPA for the treatment of acute and chronic pain.
13,
. SHR0302 tablets
SHR-0302 is a JAK1 inhibitor developed by Hengrui, Jiangsu Province, and is currently in the clinical phase III of the treatment of rheumatoid arthritis, and is in the clinical phase II of treatment, ulcerative colitis, terioderitis and Crohn's disease.
SHR-0302 was developed by Heng Rui and will award Arcutis some of its interests in research in the field of external dermatology to Arcutis, and global interests in the field of rheumatoid arthritis and external dermatology to Ruishi Bio (the company invested by Hengrui).
research and development milestone
on February 18, 2020, the drug's clinical trial application was approved by CDE. In May 2020, SHR-0302 was implicitly approved by clinical trials to be used to treat active aggressive scoliosis.
November 15, 2019, a clinical trial application for the drug was requested by CDE. In February 2020, SHR-0302 was granted implicit permission from a clinical trial to treat baldness.
August 7, 2019, a clinical trial application for the drug was granted by CDE. In October 2019, Ruishi Bio received the SHR0302 alkaline ointment "Clinical Trial Notice" approved by the State Drug Administration, which is intended to be applicable to the treatment of adhesive dermatitis.
May 2019, nMPA's Phase II clinical approval was obtained for the treatment of moderate to severe adhesion dermatitis.
April 12, 2019, Ruishi BiopharmaceuticalCo., Ltd. has received a letter of approval from the Polish Pharmaceutical, Medical Devices and Biological Products Registry and will conduct clinical trials in the near future.
January 26, 2019, Ruishi Biopharmaceutical Co., Ltd. submitted a clinical trial application (Class 1) to the State Drug Administration. In April 2019, it was granted an implied license for clinical trials to be used to treat aspecific dermatitis.
December 20, 2018, a clinical trial application filed by Ruishi BiopharmaceuticalS Ltd. with the Polish Drug, Medical Devices and Biological Products Registry was accepted for ulcerative colitis and Crohn's disease.
December 2018, SHR-0302's Crohn's Disease Phase II clinical study application was approved by the U.S. FDA.
September 3, 2018, Ruishi Biopharmaceutical Co., Ltd. submitted a clinical trial application to the State Drug Administration (Class 1). In January 2019, a clinical trial was granted with an implied approval for the treatment of Crohn's disease and moderate to severe ulcerative colitis.
October 2018, SHR-0302 in the United States has been approved by the FDA for the treatment of ulcerative colitis.
August 2018, a clinical application was resubmitted in China.
September 2017, the multicenter, randomized, double-blind, placebo-controlled phase II study (NCT03254966, SHR0302-201, CTR20170943) in patients with moderate to severe active rheumatoid arthritis evaluated the efficacy and safety of SHR-0302 tablets.
May 2015, the Single Center, Randomized, Double Blind, Placebo-controlled Clinical Phase I Study (NCT02423538, CTR20150251, SHR0302-101) was initiated in China and completed in January 2018.
July 2013, jiangsu Hengrui Pharmaceutical Co., Ltd. and Shanghai Hengrui Pharmaceutical Co., Ltd. jointly submitted a clinical trial application to the CFDA (Class 1.1 chemical drugs) and obtained the clinical trial approval in February 2015.
Financing and Transactions
In January 2018, Jiangsu Hengrui entered into a cooperation agreement with Arcutis of the United States. Under the agreement, Arcutis will receive SHR-0302 as a local external formulation for the treatment of skin diseases, with exclusive clinical development, registration and marketing rights in the United States, the European Union and Japan, while Hengrui will receive a total of $223 million in down payments and milestones, plus sales bonuses.
14,
. LX-086
LX-086 is a PI3K alpha inhibitor developed by Shandong Luoxin Pharmaceutical Co., Ltd. and is in the clinical stage of the treatment of advanced solid tumors.
Research and Development Milestone
On March 6, 2020, the ind application for the drug was sponsored by the State Drug Administration (NMPA) as a chemical drug class. In May 2020, the drug was granted clinical incuratic approval by NMPA for the treatment of advanced solid tumors.
15,
. CS3005 tablets
CS-3005 is a adenosine A2a receptor antagonist developed by Keystone Pharmaceuticals, which is in the clinical first phase of the treatment of solid tumors.
Research and Development Milestone
On March 6, 2020, the ind application for the drug was sponsored by the State Drug Administration (NMPA) as a chemical drug class. In May 2020, the drug was granted clinical incurtapproval by NMPA for use in the treatment of advanced solid tumors with other drugs (e.g. anti-PD-1 monoantinos, protease inhibitors, etc.), including but not limited to renal cell cancer, non-small cell lung cancer, colorectal cancer, sanycancer, pancreatic cancer, ovarian cancer, esophageal cancer, head and neck cancer, bladder cancer, melanoma and prostate cancer.
December 2019, the drug was approved by the Australian Commission on Human Research Ethics for Clinical Trial Senforcement And the Australian Medicines Authority (TGA) for phase I clinical trials.
16,
. SHR6390
SHR6390 is a CDK4/6 selective inhibitor developed by Hengrui, Jiangsu Province, in the clinical phase I/ II study of breast cancer and the clinical phase I study of malignant melanoma.
research and development milestones
march 7, 2020, the drug's IND application was sponsored by the State Drug Administration (NMPA) as a generics class. In May 2020, the drug was clinically implied lying to treat advanced solid tumors in combination with malic acid famithinib capsules.
August 1, 2019, SHR6390 clinical trial application was approved by CDE, in October by clinical trial simplied permission, to be combined with fluovarius group for HR-positive, HER2-negative endocrine progress of recurrent or metastatic breast cancer treatment, as well as the proposed combination of tetrasmal/anavorazole for HR-positive, HER2-negative post-endocrine progressive recurrence or metastatic breast cancer treatment.
April 2019, The SHR6390 Joint Fluovirs group for the treatment of second-line HR plus HER2-advanced breast cancer multicenter, randomized, double-blind, placebo-controlled phase III clinical studies (CTR2019619) began in China.
March 2018, SHR6390 combined to treat hormone-receptor-positive, HER2-negative advanced breast cancer.