In a multicenter, open, dose-escalating, phase I study of DS-1001 in the treatment of recurrent/progressive IDH1 mutation gliomas, it was shown that 125-1400 mg of DS-1001 were taken twice daily.

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"Collecting cycle: September 5th to September 9th, including "first application for clinical application" and "first application for marketing" chemical and biological drugs ”

NDA Summary

1, Ruimeijipan

On September 6, 2022, according to the announcement of the Drug Review Center of the State Drug Administration of China (CDE), Biohaven's Ruimeijipan's application for listing was accepted. Remejipan is an oral calcitonin gene-associated peptide (CGRP) receptor antagonist, which has been approved by the United States for acute treatment of migraine in adults. migraine is a chronic neurological disease characterized by recurrent headaches. It is usually unilateral headache, paroxysmal headache, accompanied by photophobia, phonophobia, nausea and vomiting. More than 1 billion people worldwide suffer from migraines, three-quarters of whom are women. Most traditional oral prophylactic treatments (such as beta blockers, antiepileptic drugs and tricyclic antidepressants) are not developed specifically for migraines, and their safety and tolerance are generally poorly resistant to clinically patients. The compliance is also poor. In a multi-center, randomized, double-blind , placebo-controlled trial conducted by 92 research centers in the United States, the Remejipan group was better than the placebo at the primary endpoint of the change in average migraine days per month. Group; Taking Ruimeijipan the next day can effectively prevent migraine and be safe to tolerate it.

2, tielpopeptide

On September 6, 2022, according to the CDE, Eli Lilly Pharmaceutical's tielpopeptide injection was applied for market in China. Telpopeptide is a GLP-1R/GIPR dual agonist administered once a week and has beaten semegglutide head-to-head in a large phase III clinic. GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulin secretion polypeptide) are both polypeptide , which can bind to receptors on pancreatic islet cells and stimulate . Insulin secretion, which in turn produces a role in reducing blood sugar, can also reduce food intake and delay gastric emptying of , and control weight; the latter has functions such as inhibiting gastric acid/pepsin secretion, stimulating insulin release, inhibiting gastric peristalsis and emptying. . In May 2022, FDA approved the application for marketing of tilpopeptide injection, as an auxiliary means of diet and exercise to control the blood sugar of diabetes adults.

IND summary

1, LM-101 injection

022 On September 5, 2022, according to the CDE public announcement, the application for the clinical trial of Lixin Pharmaceutical's LM-101 has been accepted. LM-101 monoclonal antibody is independently developed by Lixin Pharmaceutical and is mainly used to treat patients with solid tumors, and hematomas. The target has not been disclosed.

2, AB-218

022 On September 5, 2022, according to the CDE, the application for the clinical trial of Baoyuan Bio's AB-218 has been accepted. AB-218 (DS-1001) is an oral brain osmotic mutant IDH1 selective inhibitor, with good tolerance and good brain distribution, and can be used to treat a variety of solid tumors with mIDH1 mutations. In a multicenter, open, dose-escalating, phase I study of DS-1001 for the treatment of recurrent/progressive IDH1 mutations (R132) gliomas, it was shown that DS-1001 was taken twice daily. It was shown that DS-1001 is well tolerated, has good brain distribution, and patients with recurrent/progressive IDH1 mutant glioma respond to treatment.

3, BEBT-607

On September 6, 2022, according to the CDE, the application for the clinical trial of BEBT-607 of Bibet has been accepted. BEBT-607 is a KRAS G12C inhibitor. KRAS G12C is a specific KRAS submutation, the 12th codon , which is replaced by cysteine ​​, accounting for about 44% of all KRAS mutations, among which the most non-small cell lung cancer adenocarcinoma Common, accounting for 14%, followed by colorectal adenocarcinoma 3-4%, pancreatic cancer 2%, and more than 100,000 people worldwide are diagnosed with KRAS G12C mutations every year.Due to the structural characteristics of the KRAS mutant, the complexity of the signaling pathway, and the resistance of KRAS mutant tumors, KRAS was once called a "indestructible target".

4, FZJ-003

022 On September 6, 2022, according to the CDE, the compound Zhangjiang's FZJ-003 gel was approved for clinical treatment of atopic dermatitis . FZJ-003 is a JAK1 selective inhibitor. Studies have shown that JAK inhibitors can block a variety of signaling involved in immune responses and inflammatory factors, and block interleukin (IL)-4, IL-13, IL-31, etc. The JAK-STAT signaling pathway mediated by the cytokine affects the expression of downstream genes, thus playing a therapeutic role in atopic dermatitis.

5, HMI-115

022 On September 6, 2022, according to the CDE public announcement, the application for clinical trials of Heqirui's HMI-115 has been accepted. HMI-115 is a monoclonal antibody drug targeted prolactin receptor (PRLR) for the treatment of androgen hair loss. It is currently being developed to treat endometriosis , androgen hair loss, etc. In April 2019, Heqirui Medicine and Bayer Germany developed and industrialized targeted prolactin receptor HMI-115 signed an exclusive global license agreement to develop and industry multiple indications worldwide. change. The antibody showed excellent properties in animal models including NHP models and human safety studies.

6, MK-0616 capsule

On September 6, 2022, according to the CDE, the clinical trial application for Merck 's MK-0616 capsule was accepted for the treatment of hypercholesterolemia. MK-0616 is an orally administered cyclic peptide PCSK9 inhibitor. PCSK9 inhibitor reduces the degradation of LDLR by targeting PCSK9, increasing the clearance of low-density lipoprotein cholesterol levels (LDL-C), thereby reducing LDL- C level. Research data showed that among high cholesterol patients using statin , blood LDL-C in patients who took MK-0616 orally for 14 days decreased by 65% ​​from baseline.

7, KQ-L6 autologous chimeric antigen receptor T cell injection

On September 6, 2022, according to the CDE, the application for clinical trials of KQ-L6 autologous chimeric antigen receptor T cell injection of Keqi Pharmaceutical has been carried out on the basis of the application for clinical trials of KQ-L6 autologous chimeric antigen receptor T cell injection Accepted. The target of KQ-L6 has not been disclosed, and it is speculated that it may be the solid tumor target TM4SF1, which is currently being developed for solid tumors such as intestinal cancer and lung cancer. TM4SF1 is a brand new tumor stem cell target. Incorporating a variety of factors into the CAR structure can relieve the tumor microenvironment, activate the autoimmune system, kill tumor cells, and achieve significant therapeutic effect of completely clearing tumors in experimental animals. Currently, KQ-L6 has obtained positive preliminary data in human trials.

8, NBQ72S

022 On September 8, 2022, according to the CDE, the application for the clinical trial of Nantong Bencao Bada Pharmaceutical's NBQ72S has been accepted. NBQ72S is a world's first new bifunctional small molecule drug targeting human L-type amino acid transporter 1 (LAT1). LAT1 is a member of the superfamily of solute transporter (SLC), which is usually highly expressed in the blood-brain barrier (BBB), and is also highly expressed in most aggressive malignant tumors, such as glioblastoma polymorphism . Breast cancer , lung cancer and melanoma, etc. NBQ72S is transported from LAT1 through the blood-brain barrier to the brain, selectively entering tumor cells with high expression of LAT1; at the same time, it also prevents normal tissues that do not normally express LAT1 from damage. In tumor cells, NBQ72S exerts its cell killing activity by interfering with the DNA replication of from rapidly dividing tumor cells, thereby killing tumors.

9, ZVS101e

On September 8, 2022, according to the CDE, the application for the clinical trial of Beijing Zhongyin Technology's ZVS101e injection has been accepted. ZVS101e ophthalmic injection is an international leading gene replacement therapy product independently developed by Zhongyin Technology and has completely independent intellectual property rights.After subretinal injection of this product in patients with crystalline retinal degeneration (BCD), it can effectively infect retinal cells and express CYP4V2 protein in retinal pigment epithelial cells. The expressed CYP4V2 protein can compensate for the missing protein caused by gene mutations. function, thus effectively treat the recovery of retinal function in BCD patients. Preliminary results show that ZVS101e ophthalmic injection has good safety.

10, FB-1071

On September 9, 2022, according to the CDE, the application for the clinical trial of FB-1071 of Fubei Biologics has been accepted. Fubei Bio has created a product pipeline for original innovative drugs through a combination of internal research and development and authorized introduction. In 2021, Fubei Bio Bio reached an exclusive authorization cooperation with Elixiron Immunotherapeutics to obtain clinical product FB-1071 targeting tumors in mainland China and Hong Kong and Macao. Exclusive license for the development, production and commercialization of all indications other than. As the fastest-progressing project of Forbe Bio, FB-1071 can inhibit and kill microglia in the nervous system with high affinity and selectiveness, effectively block the neuroinflammatory response that drives the development of the disease, slow down nerve damage, and help nerves Cell repair. Therefore, it has the potential to treat various neurological diseases such as stroke , ALS, and Alzheimer's disease.