Ruibo Biology: RBD7022 injection
Mechanism of action: small nucleic acid drugs
Indications: primary hypercholesterolemia or mixed hyperlipidemia
According to the public information of Ruibo Biology, RBD7022 independently developedSmall nucleic acid drugs targeting PCSK9To reduce low density lipoprotein cholesterol (LDL-C). The drug targets the expression of PCSK9 mRNA in hepatocytes, inhibits the expression of PCSK9 through RNAi (RNA interference) mechanism, and then increases the number of low density lipoprotein receptors on the surface of hepatocytes, improves the scavenging ability of LDL-C, so as to reduce blood lipids.
Preclinical experimental data show that RBD7022 has good safety characteristics and strong effect on reducing blood lipids, andIts hypolipidemic effect shows the characteristics of stable lipid-lowering level and long-lasting efficacy. After a single administration, the effect can be maintained for several months, and the inhibition of LDL-C can reach more than 50%.. This time, RBD7022 has been approved for the first human clinical trial in China, and the proposed indications are:Primary (familial and nonfamilial) hypercholesterolemia or mixed hyperlipidemia characterized by elevated LDL-C。
Xingyao Kunze: HT-101 injection
Mechanism of action: siRNA drugs
Indication: chronic hepatitis B virus infection
SiRNA interferes with the mRNA of hepatitis B virus through RNA interference technology, destroys its function as a post-transcriptional translation template, and prevents the synthesis of related viral proteins such as HBsAg, thus inhibiting the formation of viral particles.
HT-101 injection is Xing Yao Kunze's first chronic hepatitis B treatment product.GalNAc-coupled siRNA innovative drugsMainly aimed at the clearance of hepatitis B surface antigen (HBsAg). According to the public data of Xing Yao Kunze, preclinical efficacy studies have shown thatAfter a single administration of HT-101, the levels of HBsAg, HBeAg and DNA were significantly decreased, especially in reducing the level of hepatitis B surface antigen (S antigen). Both middle and high dose groups could reduce S antigen by nearly 1000 times, and the efficacy remained unchanged for more than 70 days.. The drug has been approved clinically in China, and the indication is to be developed for chronic hepatitis B virus infection.
Pumis biology: PM1009 injection
Action mechanism: anti-TIGIT/PVRIG bispecific antibody
Indication: lung cancer
According to the public information of Pumis Biology, PM1009 is aAnti-TIGIT/PVRIG bispecific antibodyJointly developed by Pumis and Adimab. Preclinical studies have shown that PM1009 can bind TIGIT and PVRIG proteins of human and crab-eating monkeys with high affinity, remove TIGIT/CD155/CD112 and PVRIG/CD112 immunosuppressive signals, and cis-enhance CD226 activation signals. In the PD-1 drug resistance modelThe combination of PM1009 and anti-PD-1 monoclonal antibody has significant synergistic anti-tumor activity, which is expected to provide a new treatment for patients with PD-1 monoclonal antibody resistance.。
Previously, the results of PM1009's preclinical research were presented at the American Association for Cancer Research (AACR) annual meeting in 2022. This time, the drug has been approved clinically in China, and the proposed indications arelung cancer。
Saino Hubble Pharmaceutical: BT-114143 injection
Mechanism of action: plasmin (proto) inhibitors
Indications: treatment and prevention of various bleeding and diseases caused by hyperfibrinolysis
In clinic, bleeding is one of the common perioperative complications, especially in cardiovascular surgery, liver transplantation and hepatectomy, as well as orthopedic surgery such as hip and knee replacement and spinal surgery. In addition, massive hemorrhage and hemorrhagic shock caused by trauma is also one of the main causes of death.
BT-114143 is a brand new model independently developed by Saino Hubble Pharmaceutical Co., Ltd.Small molecular fibrinolytic enzyme / proenzyme inhibitorBy blocking the binding of plasminogen to fibrin and inhibiting the degradation of fibrin, it can play the role of hemostasis. According to the public information of Saino Hubble Pharmaceutical Industry, this product is developed as an injection and is intended to be administered intravenously. The drug has been approved clinically in China.It is intended to be used to treat and prevent various bleeding and diseases caused by hyperfibrinolysis.At the same time, Xeno Hubble is developing BT-114143 muscle injection, which is intended to be used in trauma first aid on special occasions such as natural disasters and emergencies.
Essen Pharmaceutical: STI-6129 injection
Mechanism of action: antibody-coupled drugs targeting CD38
Indication: multiple myeloma
CD38 is a type II transmembrane glycoprotein. Its expression is related to a variety of diseases, including AIDS, autoimmune diseases (such as systemic lupus erythematosus), type 2 diabetes, osteoporosis and cancer, especially in multiple myeloma. Therefore, CD38 has also become a potential therapeutic target for a variety of diseases.
According to public information, STI-6129 is aAntibody-coupled drugs targeting CD38, using the CD38 specific antibody screened by Sorrento Therapeutics's technology platform, and the proprietary small molecule toxin Duostatin 5. Sorrento is currently conducting a phase 2 clinical study in the United States to evaluate the treatment of the drug.Patients with late recurrent and / or refractory systemic light chain (AL) amyloidosisThe curative effect. ACEA Therapeutics was previously acquired by Sorrento and became a wholly owned subsidiary. This time, the STI-6129 injection declared by Essen Pharmaceutical has been approved clinically, and the treatment is planned to be developed.Recurrent or refractory multiple myeloma。
Kanghong Pharmaceutical: KH617 for injection
Mechanism of action: new synthetic biological drugs
Indication: advanced solid tumor
According to the announcement of Kanghong Pharmaceutical Industry, KH617 for injection is its subsidiary Honghe Biology.Synthetic Biology platform is the first product to be declared in clinical trials., for a chemical medicine class 1 innovative medicine The product uses biosynthesis technology to produce high-purity API, and its preparation shows good anti-tumor effect on a variety of solid tumors in several preclinical disease models, especially in the glioblastoma in situ model. The drug has been approved clinically in China and is intended to be developed for treatment.Patients with advanced solid tumors (including adult diffuse gliomas). The drug has also been approved clinically in the United States for advanced solid tumors and recurrent glioblastomas.
Honghe Medicine: XH- 5102 tabletsMechanism of action: JAK2 inhibitorsIndication: myeloproliferative tumorMyeloproliferative tumor is a life-threatening hematological malignant tumor, which is mainly caused by the imbalance of JAK signal transduction factor and transcriptional activator (STAT) signal network and the aggravation of inflammatory state, including primary or secondary bone marrow fibrosis, eucythemia, primary thrombocytosis and other diseases. According to the Honghe medical press release, XH-5102 tablets areHighly selective JAK2 inhibitorIt has higher selectivity and activity to the target, which can effectively avoid serious side effects such as hemocytopenia, infection, secondary tumor and so on. In addition, XH-5102 is used as a therapeutic drug for autoimmune diseases. This time, the drug has been approved clinically in China, and the treatment is to be developed.Myeloproliferative tumor。
Jinsai Pharmaceutical: EG017 tablets
Mechanism of action: selective androgen receptor modulator
Indication: breast cancer
According to the public information of Jinsai Pharmaceutical Industry, EG017 is a model transferred by Jinsai Pharmaceutical Co., Ltd from Ningbo Xijian Pharmaceutical.Selective androgen receptor regulator (SARM)It shows similar androgen-like activity to androgen receptors, such as promoting the synthetic metabolic function of tissue cells, but can avoid the toxic side effects of androgen, such as female masculinity, prostate and hepatotoxicity.
Earlier, EG017 tablets have been approved for clinical use in China for indicationsIncluding stress urinary incontinence in middle-aged and elderly women who do not consider childbearing, and dry eyes in middle-aged and elderly women who do not consider childbearing.. The clinical indications of the approved drug arePostmenopausal advanced breast cancer with positive androgen receptor, positive estrogen receptor and negative human epidermal growth factor receptor-2. In addition to EG017 tablets, Jinsai Pharmaceutical has also developed EG017 cream products, which have been approved for clinical use in China.
INNOVENT BIO: IBI333Mechanism of action: VEGF-A/VEGF-C bispecific antibodyIndications: neovascular age-related macular degenerationAccording to public information, IBI333 is aVEGF-A/VEGF-C bispecific antibodyAnd can target both VEGF-An and VEGF-C. In the laser-induced choroidal neovascularization model, IBI333 can inhibit free VEGF-An and VEGF-C. The researchers hope that the design of IBI333 will achieve better efficacy than the anti-VEGF drugs currently on the market, as well as better results for patients with Polypoid choroidal vascular disease. This time, the drug has been approved clinically for the first time in China, and the indication is neovascular age-related macular degeneration.
Primordial organism: autologous T cell injection targeting GPC3 chimeric antigen receptorMechanism of action: CAR-T drugs targeting GPC3Indication: advanced hepatocellular carcinomaAccording to the original biological press release, Ori-C101 is a CAR-T drug targeting GPC3, with high specificity and high affinity targeting GPC3 all-human antibody sequence and unique signal activating element Ori. This product can double the expansion efficiency of memory immune cells, effectively break through the physical barrier of extracellular matrix in tumor microenvironment, resist the immunosuppression of tumor microenvironment, enhance the anti-tumor activity and persistence of CAR-T in vivo, and has better potential to prevent recurrence. This time, the drug has been approved clinically in China for the treatment of advanced hepatocellular carcinoma.Qinhao Medicine: GH55 capsuleMechanism of action: dual-mechanism ERK1/2 inhibitorsIndication: advanced solid tumor with MAPK signal pathway mutationAccording to the public data of Qinhao Pharmaceutical, GH55 is a dual-mechanism ERK1/2 inhibitor, which not only inhibits the activity of ERK1/2 kinase, but also inhibits the activation of ERK1/2 by MEK and prevents drug resistance caused by negative feedback regulation. The drug has been approved clinically in China and is intended to develop the treatment of advanced solid tumors with mutations in MAPK signaling pathway. In addition to clinical approval in China, GH55's application for clinical trials in the United States is also under active preparation.Baiotai Biology: BAT8007 for injectionMechanism of action: ADC targeting Nectin-4Indication: advanced solid tumor
According to the Baiotai biological press release, BAT8007 was developed by Baiotai.ADC targeting Nectin-4The recombinant humanized anti-Nectin-4 antibody was ligated with a toxic small molecule topoisomerase I inhibitor through a cleavable linker developed by ourselves. BAT8007 has high antitumor activity.Small molecules of toxin have strong bystander effect and can effectively overcome the heterogeneity of tumor tissue.. At the same time, BAT8007 has good stability and safety, and the small molecules of toxin released in plasma are low, which reduces the risk of off-target toxicity. The drug has been approved clinically, and the indications areAdvanced solid tumor。
This article comes from the official account of "Medical View Lan" Wechat, compiled for Wuxi Apptec content team; Zhitong Financial Editor: Wen Wen.