Highlights of this issue
(1) The Phase 3 clinical trial of Akeso's Cadonilib in gastric cancer reached the endpoint
(2) Daiichi Sankyo/AstraZeneca Enhertu for a new indication for gastric cancer was included in the priority review
(3) CSPC/Alphamab Oncology KN026 is intended to be a Breakthrough Therapy for the second-line treatment of gastric cancer
(4) Positive progress has been made in the phase 2 clinical trial of Glyde's anti-TIGIT monoclonal antibody for gastric cancer
(5) MetroBiotech completed tens of millions of Pre-B round of financing
(6) Hanyu Pharmaceutical's liraglutide generic drug received an order of 100 million yuan
(1) The Phase 3 clinical trial of Akeso's Cadonilib in gastric cancer reached the endpoint
Author:
Interpretation: A bad bean
Source: Pharmaceutical Cube Info
Published: 2023-11-07
■ Highlights of the contents
On November 7, Akeso announced that the Phase 3 clinical trial AK104-302 of Cadonilib in combination with XELOX chemotherapy regimen for the first-line treatment of patients with unresectable, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma met the primary evaluation endpoint of overall survival.
The AK104-302 study is a multicenter, randomized, double-blind trial. The results of the interim analysis showed that cadonilib plus chemotherapy significantly extended the overall survival of patients compared with placebo plus chemotherapy, met the preset efficacy criteria, and continued the efficacy advantages of the previous phase 2 study.
Cadonilib is the world's first PD-1/CTLA-4 bispecific immuno-oncology preparation independently developed by Akeso, which is expected to break through the existing treatment barriers and optimize the treatment of advanced gastric cancer. The Independent Data Oversight Committee recommended that the marketing application for the new indication be submitted in advance based on the results of the interim analysis.
Original link:
https://mp.weixin.qq.com/s/EJ7gnFip43mC4tQxiyXKHg
(2) Daiichi Sankyo/AstraZeneca Enhertu for a new indication for gastric cancer was included in the priority review
Author: Medicine Cube Info
Interpretation: Hi Si Miao
Source: Pharmaceutical Cube Info
Published: 2023-11-08
■ Highlights of the contents
On November 6, according to the official website of the Center for Drug Evaluation of the National Medical Products Administration, the marketing application for the new indication of trastuzumab (Enhertu) jointly developed by Daiichi Sankyo and AstraZeneca is intended to be included in the priority review, and the proposed indication is: monotherapy for the treatment of locally advanced or metastatic, HER2-positive adult patients with gastric or gastroesophageal junction (G/GEJ) adenocarcinoma who have received two or more prior treatment regimens.
Previously, trastuzumab achieved positive results in the DESTINY-Gastric01 trial in patients with these indications. The data showed significant improvements in objective response rates (51.3 versus 14.3 percent) and overall survival (median overall survival: 12.5 versus 8.4 months) compared to patients treated with chemotherapy.
In another DESTINY-Gastric02 clinical study in Western gastric cancer patients, trastuzumab also achieved positive results in patients with these indications. In the main analysis of the trial, trastuzumab achieved an overall response rate (ORR) of 38%, including a complete response (CR) of 3.8% and a partial response (PR) of 34.2%.
Original link:
https://mp.weixin.qq.com/s/2ruuiu1hu2rhoE4CKFEPLw
(3) CSPC/Alphamab Oncology KN026 is intended to be a Breakthrough Therapy for the second-line treatment of gastric cancer
Author:
Interpretation: A bad bean
Source: Pharmaceutical Cube Info
Published: 2023-11-06
■ Highlights of the contents
On November 6, CSPC Pharmaceutical Group and Alphamab Oncology jointly announced that KN026, a recombinant humanized anti-HER2 bispecific antibody injection jointly developed by the two companies, has been granted Breakthrough Therapy Designation by the NMPA, and the proposed indication is that the combination chemotherapy drug is used for the treatment of HER2-positive, locally advanced recurrent or metastatic gastric cancer (including gastric-esophageal junction adenocarcinoma) that has failed first-line standard chemotherapy (trastuzumab plus chemotherapy).
HER2 overexpression is associated with tumor aggressiveness and poor prognosis, and KN026 can bind to two nonoverlapping epitopes of HER2 simultaneously, resulting in HER2 signal blockade. Data from the Phase 2 clinical trial showed that KN026 as a monotherapy has significant efficacy and a good safety profile in patients who have failed prior anti-HER2 therapy, and has obvious clinical advantages compared with existing treatments.
Currently, the Phase 3 clinical trial of KN026 in this indication is in the patient enrollment stage. The Breakthrough Therapy Designation for KN026 will accelerate its development and review process, and is expected to be the first drug to target second-line anti-HER2 therapies for gastric cancer that have failed HER2-targeted therapy.
Original link:
https://mp.weixin.qq.com/s/2nEjmNa2PGlgo4tQjPwmiw
(4) Positive progress has been made in the phase 2 clinical trial of Glyde's anti-TIGIT monoclonal antibody for gastric cancer
Artist: Yoshinori
Interpretation: Richard
Source: Geelyde's official website
Published: 2023-11-06
■ Highlights of the contents
On November 6, Geille and Arcus Biosciences announced the preliminary analysis results of the Arm A1 part of the EDGE-Gastric study, patients with adenocarcinoma (G/GEJ) of the stomach or gastroesophagus who received anti-TIGIT monoclonal antibody Domvanalimab combined with Zimberelimab plus chemotherapy. Demonstrated higher clinical benefit in overall response rate (ORR) and progression-free survival (PFS) over six months.
Domvanalimab is a Fc-silencing IgG1 monoclonal antibody developed by Arcus Bioscience to target TIGIT, which can inhibit the function of TIGIT, block the binding of CD155 on the surface of cancer cells to TIGIT on the surface of immune cells, so that CD155 can bind to DNAM-1 protein and activate the immune signaling pathway.
As of the analysis on September 3, 2023, among patients receiving a Domvanalimab-containing regimen, the ORR of patients with high and low PD-L1 expression was 80% and 46%, respectively, and the overall ORR was 59%; The PFS rates at six months were 93% and 68%, respectively, and the overall PFS rate was 77%.
Original link:
https://www.gilead.com/news-and-press/press-room/press-releases/2023/11/gilead-and-arcus-announce-new-data-showing-encouraging-clinical-activity-of-anti-tigit-domvanalimab-containing-regimen-as-first-line-treatment-for-upp
(5) MetroBiotech completed tens of millions of Pre-B round of financing
Author: Arterial.com
Interpretation: Richard
Source: Arterial Network
Published: 2023-11-06
■ Highlights of the contents
Recently, Zhejiang Mozhuo Biotech successfully completed tens of millions of yuan in Pre-B round of financing. This round of financing is exclusively invested by Fuzhejiang Technology, with Dianshi Capital as the exclusive financial advisor. The new round of financing will be used to help the commercialization of Motro Biotech, build an international leading life science tool platform and help its application landing.
Mozo Biotech is deeply engaged in the field of life science tools and is committed to becoming an international leading biotechnology tool platform. At present, Motro Biosciences has formed a variety of platform-based product lines such as high-throughput single-cell multi-omics sequencing, microbial single-cell sequencing, and single-cell sorting, providing an overall solution integrating instruments, chips, reagents and bioinformatics software.
MobiNova-100, the core product of MobiNova, has broken the monopoly of domestic single-cell sequencing tool imports that has lasted for many years. At present, Metro Biosciences has preliminarily built a single-cell sequencing ecology of Metro Biologics, which comprehensively covers scientific research, drug research and development, assisted reproduction, tumor medication guidance, agricultural breeding and synthetic biology.
Original link:
https://mp.weixin.qq.com/s/4YYHObgvB89ycAo1E5wl-A
(6) Hanyu Pharmaceutical's liraglutide generic drug received an order of 100 million yuan
Author: Hanyu Pharmaceutical
Interpretation: Richard
Source: Oriental Fortune Network
Published: 2023-11-04
■ Highlights of the contents
On November 4, Shenzhen Hanyu Pharmaceutical announced that its generic liraglutide pre-filled injection pen preparation product received a total of 14.0832 million US dollars (about 103 million yuan) purchase orders from partners.
Based on the settlement agreement reached between the partner and the original drug Novo Nordisk, the partner can sell the generic drug of liraglutide injection in the United States at the time agreed in the out-of-court settlement in 2024, and it is qualified to sell.
Founded more than 20 years ago, Hanyu Pharmaceuticals has focused on the development of peptide drugs, and is one of the few companies in the A-share peptide listed company that can be recognized by major pharmaceutical companies in the United States to successfully sell commercial batch peptide APIs to the United States. At present, the layout of the peptide weight loss and hypoglycemic pipeline includes: tirpatide, semaglutide, liraglutide, exenatide, metformin sustained-release tablets, sitagliptin, metformin and vildagliptin.
Original link:
https://data.eastmoney.com/notices/detail/300199/AN202311031608338446.html