In this period, 54 new drug applications were granted default permission for clinical trials, involving 27 domestic new drugs and 9 imported new drugs. The approved clinical innovative drugs include BCL-2 inhibitors, third-generation BTK inhibitors, FAK inhibitors, JAK1 inhibitors, GARP mAb, LAG-3 mAb, OX40 agonists, BTLA mAb, PD-L1 / TGF- β RII bifunctional fusion protein, HER2 ADC, and the indications include multiple hematological tumors, solid tumors, Alzheimer's disease, inflammatory arthrodiseases, osteonecrosis, schizophrenia, and dry eye diseases, etc.
1.LP-108 tablets
LP-108 tablet is a novel and highly selective BCL-2 inhibitor developed by Lupeng Pharmaceutical. The approved clinical indication is combining azacitidine in the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or chronic granule-mononocytic leukemia (CMML)
2.HBW-3210 capsules
HBW-3210 capsule is a strong-brain-penetrating and reversible anti-drug-resistant triple-generation BTK inhibitor independently developed by Haibo, which is planned to be developed to treat B-cell non-Hodgkin's lymphoma. According to Haibo pharmaceutical press release, HBW-3210 can overcome the resistance of the first and second-generation BTK inhibitors due to C481S mutation, and has high inhibitory activity against both wild-type and mutant BTK; and the drug has strong brain transmission, HBW-3210 has outstanding advantages in brain penetration (rat brain penetration rate> 60% VS ~10%), effectiveness.
3.IN10018 film
N10018 is an efficient and highly selective ATP competitive adhesion kinase (FAK) inhibitor introduced by Yingshi Biology from Boringer Ingelheim (BI). It is currently being developed for a variety of solid tumor indications including ovarian cancer, melanoma, triple-negative breast cancer, head and neck tumors, KRAS G12C mutated tumors, and pancreatic cancer.
In May 2020, Ying Shi Biology reached a partnership with Corning and Jerry Corning to jointly carry out a clinical study on the PD-L1 / CTLA-4 bispecific antibody KN046 and IN10018 combination therapy. IN10018 in combination with KN046 and standard chemotherapy (albumin paclitaxel + gemcitabine) were approved for the treatment of advanced pancreatic cancer.
4.VC005 pieces
VC005 tablet is a new and highly selective JAK1 inhibitor independently developed by Weikil Medicine, which can effectively inhibit TYK2 and other inflammatory targets, and inhibit the immune cell-mediated cytotoxicity and immune response. It has weak inhibitory activity against JAK2 and JAK3, and has good selectivity of compounds. The drug has previously been approved for clinical trials of inflammatory bowel disease (IBD), and approved for inflammatory arthropathy (inflammatory joint diseases, IJD), including rheumatoid arthritis and ankylosing spondylitis.
5. Obbitzine fumarate
Fumarate intestinal soluble micropill capsule (SM-1) is a potential "first-in-class" Procaspase-3 target developed by Shenzhen Zhenxing Pharmaceutical. At present, the study of monotherapy for the treatment of advanced solid tumors has entered phase II clinical practice, and the research results show that the drug has good safety and efficacy. This approval is a safety, pharmacokinetic phase I clinical study of SM-1 combined with radiotherapy in subjects with locally advanced HNSCC.
6.RAB001 fluid injection
RAB001 is obtained from the American Bone and Joint regenerative Medicine Company (Regenerative Arthritis & Bone Medicine, Inc.) A small molecule polypeptide coupled dual targeted innovation for non-traumatic osteonecrosis. Relcontrast to other exogenous stem cell therapies, RAB001 targets endogenous stem cells to bone, improves blood circulation, repairs osteonecrosis, and stimulates new bone formation.
7.RX04 capsule
RX04 capsule is an innovative drug developed by Sun xin to study the treatment of Alzheimer's disease.
8.SYS6002
SYS6002 is a biological class 1 innovative drug developed by Shiyao Group, to carry out research to treat solid tumors.
9.HLX60
HLX60 (that is, recombinant anti-GARP humanized monoclonal antibody injection) is an innovative anti-GARP mAb independently developed by Fosun Pharma, which was approved to carry out phase I clinical trials of solid tumors and lymphoma. It is worth mentioning that in August 2022, a phase I clinical trial of HLX60 combined with Hans (Srulizumab injection) for advanced / metastatic solid tumors was approved in Australia. Currently, no monoclonal antibodies targeting GARP have been approved for marketing worldwide.
10. Ossellizumab injection of the No
Ossperlizumab (BGB-A1217) is a developing anti-TIGIT monoclonal antibody developed by Beigene with perfect Fc function, which has launched a number of later clinical trials worldwide, and was approved by NMPA for the neoadjuvant treatment of resectable stage II to stage IIIA non-small cell lung cancer.In addition, Beigene has reached strategic options, cooperation and licensing agreements with Novartis to jointly develop, produce and commercialize Ossellizumab in North America, Europe and Japan.
11.LBL-007 injection solution
LBL-007 injection is a fully human anti-LAG-3 antibody drug independently developed by Nanjing Weilibo. In December 2021, Weilibo granted the global research and development and production license of LBL-007 and the exclusive commercial rights outside China. Two clinical trials were approved: neoadjuvant therapy and microsatellite stable / mismatch repair of complete resectable stage II to stage IIIA non-small cell lung cancer in colorectal cancer
12.BGB-A445 injection solution
BGB-A445 is an OX40 agonist antibody developed by Baigene, with no same target drug on the market worldwide. The OX40 antibodies from multinational pharmaceutical companies such as AstraZeneca, Pfizer, GSK and Roche have all entered the phase II clinical stage. However, the clinical phase II treatment of Roche pogalizumab for urothelial cancer has been terminated due to slow patient recruitment. Previously, BGB-A445 has been approved abroad, and NMPA has approved it to carry out clinical studies on BGB-A445 monotherapy or in combination with terellizumab for advanced solid tumors in China.
13. Recombinant humanized anti-BTLA monoclonal antibody injection solution
icatolimab (TAB004 / JS004) is a recombinant humanized anti-BTLA monoclonal antibody specific to the B and T lymphocyte attenuation factor (BTLA).icatolimab was approved for clinical research in the United States and China in 2019 and 2020, respectively. It is the world's first anti-tumor BTLA (B / T lymphocyte weakening factor) mAb for clinical research, and has now entered the phase Ib / II clinical research stage in both China and the United States. At this year's ASCO annual meeting, Junshi said that Icatolimab monotherapy or in combination with tripllimab tolerated patients with R / R lymphoma and showed initial clinical efficacy. A new indication was approved for clinical use: JS004 combined with terriplumab and combined with or without standard chemotherapy for advanced lung cancer.
14.SHR-1701 injection solution
SHR-1701 is an anti-PD-L1 / TGF- β RII bifunctional fusion protein independently developed by Hengrui Pharmaceutical and with intellectual property rights. It can promote the activation of effector T cells, and can also effectively improve the immune regulation in the tumor microenvironment, and finally effectively promote the killing of the immune system to tumor cells. At present, SHR-1701 injection has been carried out in a number of clinical trials of solid tumors in China, including nasopharyngeal cancer, cervical cancer, non-squamous non-small cell lung cancer, advanced colorectal cancer, and phase I clinical trials in Australia. The clinical study of HER2-positive gastric or gastroesophageal junction adenocarcinoma was approved.
15. SHR-A1811 for injection
SHR-A1811 for injection is an antibody-conjugated drug (ADC) independently developed by Hengrui Pharmaceutical to target HER2. It has been approved to carry out clinical trials of HER2-abnormal non-small cell lung cancer and HER2-positive breast cancer, and of adenocarcinoma of HER2-positive gastric or gastroesophageal junction.
16.KP104 injection solution
KP104 is a dual-target complement biologic developed by Kuwait Vietnam Medicine. KP104 is currently entering phase 2 clinical trials for several indications, including IgA nephropathy (IgAN), C3 glomerulopathy (C3G), thrombotic microangiopathy (SLE-TMA) secondary to systemic lupus erythematosus, and paroxysmal sleep hemoglobinuria, and has been eligible by the FDA for the treatment of PNH. Approved in China is a phase 2 clinical trial designed to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in Chinese patients with paroxysmal sleep hemoglobinuria.
17.GQ1005 injection solution
GQ1005 injection is a HER2 ADC drug developed by Kai Tak Pharma to study adult patients with advanced solid tumors expressing human epidermal growth factor receptor 2 (HER2).
18.DS003 lyophilized powder needles
DS003 lyophilized powder needle is a biological innovative drug developed by Dashi Pharmaceutical, planning to carry out research on the treatment of advanced malignant solid tumors.
