Recently, a reporter from China Securities Journal visited the Xinda Biotech Global R&D Center (Medical) in person. The research and development center is located in the New Hongqiao International Medical Center in the Hongqiao Business District of Shanghai, and was officially opened in August this year. Relying on the national strategy of integrating the Yangtze River Delta, Xinda Biotechnology has formed a three in one coordinated development situation of Suzhou headquarters, Shanghai R&D center, and Hangzhou industrialization base.

Xinda Biotech has been deeply involved in the field of innovative drugs for more than ten years, including the first PD-1 inhibitor to be included in the national medical insurance catalog (Daboshu), the world's first GCG/GLP-1 dual receptor agonist, Masidopeptide, and the first domestically developed PCSK9 inhibitor, Trastuzumab Injection (Xinbile). Looking ahead to the future, Qian Lei, Senior Vice President of Clinical at Xinda Biotechnology, stated in an interview with China Securities Journal that Xinda Biotechnology will continue to promote high-quality clinical development of its tumor product line, explore unmet medical needs in the field of cancer treatment, and drive global innovation. In the field of chronic diseases, Xinda Biotechnology will accelerate innovation and strive to address unmet clinical needs, providing patients with safer and more effective treatment options.

Abundant achievements in research and development innovation

Founded in 2011, Xinda Biotechnology is committed to the research and development, production, and sales of innovative drugs in major disease fields such as oncology, autoimmune diseases, metabolism, and ophthalmology. Qian Lei stated that the company's Shanghai R&D center has settled in the New Hongqiao International Medical Center located in the Hongqiao Business District of Shanghai, which meets the project construction needs in terms of regional transportation, industrial planning, and policy support. This is conducive to deepening, expanding, and strengthening the industry, and enhancing the development potential of the enterprise.

It is reported that as of now, the company has 12 products approved for market, 5 varieties are under review by the National Medical Products Administration, 3 new drug molecules have entered phase III or critical clinical research, and an additional 17 new drug varieties have entered clinical research.

It is worth mentioning that the company's innovative anti-tumor drug Daboshu (Xindilimumab) is the first PD-1 inhibitor in China to be included in the national medical insurance catalog. Going back to 2012, at that time, Xindilimumab was officially approved. In 2018, Xindilimab was officially approved by the National Medical Products Administration for the treatment of relapsed or refractory classic Hodgkin's lymphoma that has undergone at least second-line systemic chemotherapy. In 2019, Xindilimumab was included in the national medical insurance catalog as the first and only PD-1 inhibitor.

Nowadays, as a star product of Xinda Biotech, Daboshu has performed outstandingly. According to the company's announcement, in the third quarter of 2024, the total product revenue of the company exceeded 2.3 billion yuan, a year-on-year increase of over 40%. In this regard, the company stated that firstly, the sales of Daboshu maintained a strong growth momentum in the third quarter, while the sales of other major products also maintained rapid growth, mainly due to the broad indications of the company's products and the advantages of national medical insurance catalog coverage and access channels; Secondly, the company has been approved to expand its product portfolio by adding a new tumor innovative targeted drug, Dabert (Fluzelese tablets); Thirdly, thanks to competitive products and effective marketing strategies, the company's new product market penetration has accelerated, contributing new driving forces to revenue growth.

At present, Daboshu has been approved for eight indications, of which the first seven have been included in the national medical insurance catalog, "Qian Lei said. The application

Segmented tracks stand out

Strong research and development capabilities guided by innovation are the cornerstone for pharmaceutical companies to maintain long-term competitiveness. Xinda Biotechnology stated that the company will further strengthen the research and development of its oncology and integrated product lines through science driven innovative research and a development strategy centered on unmet needs.

According to the company's semi annual report, the R&D expenditure for the first half of this year reached 1.399 billion yuan. During the reporting period, significant achievements were made in multiple late stage clinical projects, and the company continued to fulfill its investments in key treatment areas such as oncology, metabolism and cardiovascular (CVM), autoimmune, and ophthalmology. As a leading biopharmaceutical company in China, we continue to focus on two long-term development strategic goals - sustainable growth and global innovation. We are steadily moving towards the goal of building Sinopharm into a biopharmaceutical company with global innovation capabilities, promoting long-term value creation. "Sinopharm stated in its 2024 interim report.

Taking the fiercely competitive GLP-1 (glucagon like peptide-1) track as an example, at the Xinda Biotech Global R&D Center (Medical), the reporter saw a sample of the GCG (glucagon)/GLP-1 dual receptor agonist Masidopeptide displayed. It is reported that in 2019, Xinda Biotechnology and Eli Lilly reached a cooperation agreement and obtained the Chinese rights of Masidopeptide.

How do GCG/GLP-1 dual receptor agonists work? Qu Shen, director of the Obesity Research Institute at Tongji University School of Medicine, recently stated at a scientific weight loss symposium held by Xinda Biology that the two main aspects of obesity treatment are reducing calorie intake and increasing calorie expenditure. Among the GCG/GLP-1 dual receptor agonists, GLP-1 receptor agonists mainly act to suppress appetite, delay gastric emptying, and reduce energy intake, while GCG receptor agonists can complement each other's strengths and weaknesses, increasing energy expenditure. This approach of opening up sources and reducing costs has a synergistic effect of "1+1>2", which is very beneficial for weight reduction.

In terms of research and development progress, as the world's first GCG/GLP-1 dual receptor agonist to be declared for market, Masidomide currently has two new indications that have been accepted and reviewed by the National Medical Products Administration, including: long-term weight control for adult obese or overweight patients; It is used for blood sugar control of adult type 2 diabetes patients.

Qian Lei predicts that Masidomide will be approved for weight loss and blood sugar lowering indications next year. When it comes to the prospects of the weight loss market, Qian Lei analyzed that the competition in the domestic GLP-1 weight loss drug market is gradually fierce, but it also indicates that the domestic weight loss market has a huge space and is full of opportunities. There are differences in the efficacy, safety, and medication methods of GLP-1 drugs among various companies, which constitute a competitive advantage among them. Good efficacy and safety are the primary factors for a product to stand out in the market.

It is reported that the company has conducted five Phase III clinical trials for Masidomide, including GLORY-1 and GLORY-2 studies in overweight or obese adult subjects in China. According to the GLORY-1 Phase III clinical study on the weight loss indication of Masidogrel, at 48 weeks of treatment, subjects in the Masidogrel 4mg and 6mg treatment groups had an average weight loss of 12.05% and 14.84% compared to baseline, while the placebo group had a weight loss of 0.47%. In addition, on December 26, 2023, the company launched the Phase III clinical trial of Maxidotide head to Maxidotide, and the study population was early type 2 diabetes patients with obesity.

Qian Lei said that in the next five years, Cinda Bio is expected to have five to six metabolic products on the market, covering diabetes, weight loss, cardiovascular and other indications, and strive to become a research and development enterprise with a certain voice in the field of cardiovascular metabolic diseases in China.

Steadily promote internationalization layout

Since the beginning of this year, policies in the innovative pharmaceutical industry have been blowing warm winds. On July 5th, the executive meeting of the State Council approved the "Implementation Plan for Supporting the Development of Innovative Drugs throughout the Whole Chain". At the same time, local governments have intensively introduced supporting policies to support the development of innovative drugs.

The approval of the "Implementation Plan for Supporting the Development of Innovative Drugs in the Whole Chain" means that the approval process for innovative drugs will be further optimized, and the time to market is expected to be shortened. This will accelerate the market access of new drugs, meet clinical needs, improve patient welfare, and encourage domestic innovative pharmaceutical companies to increase research and development investment, promoting domestic pharmaceutical innovation. Qian Lei said that enterprises should optimize their research and development pipelines based on market potential, competitiveness, and the possibility of developing drugs, and focus on projects with competitive advantages and high potential. Meanwhile, product differentiation can be considered to enhance market competitiveness. Enterprises can use policy support to strengthen cooperation and communication with the international market, and promote the global synchronous research and development, application, approval, and listing of innovative drugs.

It is worth noting that with the continuous improvement of research and development capabilities, many innovative pharmaceutical companies have chosen to go abroad to seek broader market space. Xinda Biotechnology introduces that in order to meet the needs of the company's overseas business development, the group has established subsidiaries in the United States, Europe, and Singapore, gradually achieving an international strategic layout.

Qian Lei said, "Our development strategy is' based on innovation and taking the path of globalization '. We hope that Xinda Biotech can become a truly global biopharmaceutical company, which requires long-term planning and gradual implementation

Qian Lei further stated, "Specifically, on the one hand, we have a rich product pipeline and preclinical innovation pipeline that have entered early clinical trials, which is worth exploring their global development potential. On the other hand, in the process of exploring going global, in addition to utilizing our own research and development resources, we need to consider fully utilizing external resources to accelerate the overseas development of the global potential pipeline and maximize its development value. Therefore, we have been paying attention to the exploration of overseas models such as self-developed, License Out, mergers and acquisitions, NewCo, etc. We maintain an open attitude towards these models, each with its own strengths and values. We believe that the ideal way to go global should be diversified according to the actual situation of the company's pipeline strategy arrangement. Play the combination cards well.