Transcenta Holding (06628): Product pipeline progressing well with significant competitive differentiation

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As pharmaceutical reformation is underway, the importance of the innovative strength of biotech companies has become increasingly prominent, the entire industry has also formed a completely different pattern from ten years ago. Today, differentiation has also become the general trend in the industry.

Photo: Transcenta’s Pipeline, Source: Company website
Photo: Transcenta’s ICB Platform, Source: Company website

As the interim results of Hong Kong companies have recently been announced, we might as well look for potential targets from the announcements that aim to differentiate themselves and truly bet on innovation. We found that Transcenta Holding (06628) might be worthy of attention. Transcenta has a strong focus on innovative research and development, is well advanced in international clinical trials, and has multiple competitive advantages. Let’s take a look at this Company.

Dr. Caroline Germa, Transcenta’s new CMO, accelerates the development of differentiated pipelines

The core of differentiation in the industry is First-in-class and Best-in-class. In terms of pipelines, Transcenta has injected significant innovative attributes, developing the most innovative drugs such as FIC/BIC, highlighting the advantages of differentiated clinical strategy and development, which is expected to facilitate the pipeline product approval and commercialization and address the unmet medical needs.

Moreover, it can also be seen from the clinical trial overview that Transcenta’s new drug development is more oriented toward global strategy, targeting the interests of the global market, and basically the product candidates of the Company are being developed in parallel in both China and the US. This advantage is also based on the fact that the Company has a very efficient team in both US and China, with a deep understanding of the industry, covering all aspects of discovery, research and clinical trial development and manufacturing.

The majority of Transcenta’s executives have a background of 15-20 years in leading pharmaceutical companies, with a proven track record and a well-balanced combination of expertise spanning research, clinical development, manufacturing, strategic planning and financing. At the same time, the Company has a scientific advisory team of internationally renowned experts and industry elites. In the process of moving into the global “blue ocean”, the Company is also gradually developing and growing, attracting more outstanding talents to join. Recently, the Company welcomed a new CMO, Dr. Caroline Germa, as the Company’s Executive Vice President of Global Drug Development and Chief Medical Officer.

As a leader in oncology and drug development, Dr. Germa has a high reputation in the industry, and her personal strength has been proven by many achievements. Dr. Germa has worked for AstraZeneca, Bristol-Myers Squibb (BMS), Novartis and several other internationally renowned pharmaceutical companies, and has accumulated considerable industrial experience, also involved in the development and research of a number of blockbuster drugs including Ribociclib and Neratinibfor breast cancer.

Dr. Germa’s joining Transcenta Holding will undoubtedly provide a great boost to the Company’s innovative development. In the future, with her contacts in the pharmaceutical industry and her unique and profound understanding, she will better lead Transcenta’s global expansion and make a significant contribution to enhancing the Company’s shareholder value in the future. It is not difficult to find that the Company’s team with high qualifications and deep background has laid a solid foundation for the global application and clinical development of its innovative pipeline molecules.

At present, Transcenta has built a diversified and risk-balanced pipeline of antibodies with best-in-class or first-in-class potential in therapeutic areas with high unmet medical needs, including oncology, kidney and bone diseases. Most of these molecules are discovered and developed in-house. Specifically, the Company’s oncology product pipeline targets major cancer pathways which have potential synergistic mechanisms of action for tumor indications, which is precisely the most differentiated design of the Company’s oncology pipelines. Moreover, the Company has developed a non-oncology pipeline strategy, which plays in a field facing less competition and reaches high market potential.

It is worth mentioning that the drug discovery technology of Transcenta Group is particularly impressive. Based on the unique IMTB antibody discovery platform, the company has developed a number of antibodies targeting various pooled sites above a particular target, thereby expanding the selectivity of its drug candidates. The Company has generated and is developing oncology products such as TST001, TST005, TST003 and TST010 through the IMTB technology platform. In the future, more valuable innovative drugs will be discovered and filed for global registration, helping Transcenta Group to become a leading global biotechnology company.

Rapidly advancing product pipeline, leading the world in clinical progress
The strength of Transcenta Holding is not only reflected in the layout and research and development of innovative drugs, but also in the Company’s ability to execute and facilitate clinical trials. In the first half of 2022, the Company actively advanced its product pipeline and achieved remarkable results. In particular, the Company’s flagship product, TST001, ranked second in the world in terms of clinical progress and will soon enter Phase III clinical trials.

Claudin18.2 has relatively high expression in gastric cancer, pancreatic cancer, esophageal cancer and bile duct cancer, and TST001 has high biological activity, affinity and NK cell activity, and has ideal efficacy and safety. It has a considerable commercial application prospect. At the same time, the Company has also developed a specific antibody for companion diagnostics and will use this Claudin18.2 immunohistochemical assay to support international clinical trial registration. The Company is also well ahead of schedule and at the forefront of the world in this area.

In developing TST001, Transcenta has, on the one hand, continued to explore multiple tumor types. On the other hand, the Company is also experimenting with TST001 combination regimens, and its clinical progress is likewise world-leading. Let’s keep an eye on its mid-term phase 2 clinical data for TST001 and chemotherapy combination in frontline gastric cancer patients as the company disclosed it will be published soon in a major European clinical oncology conference. This could be important to understand the potential of TST001.

Not only that, the Company’s other pipelines are also progressing smoothly, including the bifunctional humanized antibody TST005 targeting both PD-1/PD-L1 and TGF-beta pathways, the candidate product TST002, a humanized sclerostin mAb for the treatment of osteoporosis, and a high affinity humanized monoclonal antibody TST003 (FIC) and TST004, a humanized MASP-2 mAb candidate for kidney diseases. It is worth mentioning that the Company’s first-in-class targeting Gremlin1(TST003), a preclinical asset with antitumor activities in multiple difficult-to-treat tumor models was published in the international oncology authoritative journal “Nature Cancer”. In addition, the Company has also developed a series of relatively early pipeline products, which further enriched the Company’s product pipeline. As these candidate products gradually enter the clinic stages and are successively approved in the future, the Company’s intrinsic value will gain more impetus.

Actively promoting CDMO business to fully realise the source of income and reduce expenditure
In addition to product development, Transcenta Holding has also been forward-looking in the layout of commercial production. It can be seen from the Company’s results announcement that Transcenta has established a complete CMC and production platform, both for early cell line process development and GMP mass production systems, which are designed by the Company and met international standards.

Transcenta Holding utilises a novel integrated continuous bioprocessing platform (ICB) for developing robust production processes, formulations and analytics, manufacturing drug products throughout the product life cycle. The advantages of the Company’s ICB platform are significant, as its capacity is more than 10 times higher than the traditional Fed-batch flow addition process, and its cost has been significantly reduced by almost 50%. In May 2022, Transcenta successfully passed an audit by the European Union Quality Person (QP). This combination of quality and cost advantages supports the clinical studies and registration of the Company’s candidate products worldwide.

In addition, Transcenta has leveraged its CMC capabilities and the potential value of its ICB platform to further expand its CDMO business. While the CDMO business has enabled the Company to achieve open source and cost savings, it has also attracted the attention of international high-quality partners by virtue of the high-quality industry reputation accumulated in the client, and further expands international cooperation. The Company has been developing and collaborating commercially with Merck for an industry-first disposable flow-through polishing system and maintains a domestic leading position in the field of perfusion technology.

Summary
All in all, the interim results announcement of Transcenta Holding has many highlights and the Company’s competitive advantages are distinct. Whether it is drug discovery, clinical development, or commercial production, it has strong strength in all aspects. We believe that with the successful development and commercialization of the Company’s innovative and differentiated products, Transcenta will achieve leapfrog development and is worthy of long-term attention

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