In March, Viva Biotech was invited to attend several events, including the 5th Small Molecule Drug Innovation and Collaboration Forum (SIT 2023), the 2023 China-Ningbo Biomedical Industry Development Summit, CIS-Asia 2023, and the China Biomedical Innovation and Investment Conference (CBIIC).

SIT 2023

SIT 2023 was held in Shanghai on March 2-3, 2023. Dr. Jianhua Cai, Senior Vice President of Viva Biotech, and Dr. Jianguo Ma, Senior Vice President of Viva Biotech and CEO of Langhua Pharmaceutical, were invited as the keynote speakers.

Dr. Jianhua Cai, Senior Vice President of Viva Biotech

Since the invention and application of X-ray crystallography in life science research in the early 20th century, biophysical technologies have rapidly developed, including X-ray, NMR, MS, and electron microscopy. These biophysical technologies have won numerous Nobel Prizes in Chemistry or Physiology and Medicine, and at the same time, they have been widely applied in the field of drug discovery and development. Dr. Cai provided a comprehensive introduction to the application of Viva's biophysical technology platform in drug mechanism research (MOA) and drug screening. He pointed out that Viva conducts research on protein three-dimensional structures, binding affinity, binding sites, and binding dynamics, as well as screening and identification of covalent and non-covalent binding using a series of biophysical technologies, such as X-ray, Cryo-EM, HDX-MS, SPR, Intact-MS, and Native-MS. In terms of drug screening application, Viva's biophysical technology can be used for screening covalent and non-covalent compound libraries, and clients can choose to screen Viva's compound library or their own compound libraries. He emphasized the application of ASMS technology in the screening of multi-conformational proteins and introduced how to use ASMS technology to screen molecular gels. Generally, through Viva's drug screening platform, customers can obtain hits within 2-3 months. Finally, he further elaborated on the comprehensive application of Viva's biophysical technology in the drug development process using Mat2A and PCSK9 as examples.

Dr. Jianguo Ma, Senior Vice President of Viva Biotech and CEO of Langhua Pharmaceutical

Dr. Jianguo Ma shared his insights and technical experience on the research and development, production, and submission of innovative drug APIs from IND to NDA. He also provided a detailed explanation of Langhua's successful cases in API research and production in different clinical stages. In addition, he highlighted Langhua's capabilities, advantages, and successful cases in providing one-stop CMC (raw materials and formulations) services, including a first-class R&D team, advanced technology platforms for raw materials and formulations, sufficient production capacity, reliable GMP and EHS management systems, and a comprehensive IP protection system. Thanks to these capabilities, Langhua meets the one-stop CDMO needs of customers for small molecule drug research and production in an efficient, flexible, and high-quality manner.

2023 China-Ningbo Biomedical Industry Development Summit and SAPA-China Conference

Dr. Han Dai, CIO of Viva Biotech and Head of Viva BioInnovator

The China-Ningbo Biomedical Industry Development Summit and SAPA-China Conference was held in Ningbo-Qianwan from March 10-12, 2023. Dr. Han Dai, CIO of Viva Biotech and Head of Viva BioInnovator, moderated a panel discussion on MRCT's operational strategy and exchanged views with the guests. He stated that since China's accession to ICH in 2017, there have been significant reforms in China's drug administration and supervision. China is now playing an increasingly important role in global MRCT, and more and more Chinese pharmaceutical companies are integrating into the global MRCT layout by collaborating with international pharmaceutical companies and overseas teams to build clinical teams for overseas deployment. These changes have made the Chinese pharmaceutical industry ecosystem more attentive to the layout of MRCT, including related operational strategies.

CIS-Asia2023

On March 16th-17th, the 12th Chemical and Pharmaceutical International Summit-Asia (CIS-Asia 2023) was held at the Tianjin Society Hill International Conference Center. Dr. Jianguo Ma, Senior Vice President of Viva Biotech and CEO of Langhua Pharmaceutical, and Dr. Mingda Bi, Vice President of Langhua Pharmaceutical, were invited to attend the summit and deliver keynote speeches.

Dr. Jianguo Ma, Senior Vice President of Viva Biotech and CEO of Langhua Pharmaceutical

Dr. Jianguo Ma presented on the topic of "Research and Control of Genotoxic Impurities in Innovative Small Molecule Drugs" at the conference. He shared the mechanisms of genotoxicity, guiding principles and regulations related to genotoxic impurities, classification of genotoxic impurities and corresponding control strategies, toxicological thresholds (Threshold of Toxicological Concern, TTC), calculation methods for permitted daily exposure (PDE), limits and calculations for genotoxic impurities, four methods for controlling genotoxic impurities, and case studies of genotoxic impurity control. Dr. Ma also participated in a panel discussion and shared his insights on the development and validation of analysis methods.

Dr. Mingda Bi, Vice President of Langhua Pharmaceutical

In the speech on 'OM Sustained-release Tablet IVIVC Development', Dr. Mingda Bi introduced the concept of IVIVC, its applications, and considerations for collecting in vivo and in vitro data to avoid pitfalls in IVIVC development based on regulatory guidance principles. He then provided in-depth explanations of IVIVC development cases. He also participated in a panel discussion on 'Considerations and Strategies for Selecting Innovative Drug Formulations'.

CBIIC

The China Healthcare Innovation and Investment Summit was held in Suzhou from March 29th to 31st. Dr. Jianhua Cai, Senior Vice President of Viva Biotech, attended the conference and delivered a keynote speech on the theme of "Innovation-Driven, Technology-Empowered - Supporting Global Innovative Drug R&D".

Dr. Jianhua Cai, Senior Vice President of Viva Biotech

Dr. Jianhua Cai reviewed the 2022 annual results of Viva Biotech: In 2022, Viva Biotech's revenue reached RMB 2379.6 million, a year-on-year increase of approximately 13.1%; gross profit reached RMB 815.7 million, a year-on-year increase of approximately 25.3%. Among them, the CRO business has significant competitive advantages and maintains a steady growth trend. The construction of the CDMO production capacity continues to improve, and its subsidiary, Langhua Pharmaceutical, achieved a total annual revenue of RMB 1484.6 million, a year-on-year increase of nearly 8.9%, and a total gross profit of RMB 418.3 million, a year-on-year increase of nearly 35.5%. In addition, from its establishment to now, CMC has completed or is currently working on nearly 123 new drug projects. In terms of EFS investment incubation business, as of the end of 2022, Viva Biotech has invested and incubated 91 start-up companies. It plans to explore the investment incubation business by establishing an investment fund in the future.

As the innovative technologies, Dr. Cai stated that Viva has efficient protein expression production capabilities, and conducted R&D on over 1,900 proteins to date. Viva’s protein structure research is at the forefront of the industry, and delivered over 48,925 structures as of the end of 2022. In 2022, Viva conducted R&D on 226 independent drug targets, collected approximately 16,000 sets of data, and analyzed over 13,000 structures, including 10 brand new structures. Dr. Cai showcased several examples of their structural research, such as analyzing the IDH2 allosteric inhibitor co-crystal structure through X-Ray, the BRD4-PROTAC degrader-VHL ternary complex structure, the BCL-XL-PROTAC degrader-VHL ternary complex structure, and the CD47-SIRPα binding mechanism research. Additionally, Viva utilized cryo-electron microscopy to analyze the structure of ion channels, GPCRs, PROTAC ternary complexes, and multi-subunit protein complexes. Furthermore, Dr. Cai introduced Viva's affinity screening platform and corresponding proprietary compound library. He particularly emphasized that Viva has established multiple ASMS screening strategies, including UF-ASMS and UC-ASMS based on fragment-based drug discovery (FBDD) and SEC-ASMS specifically designed for a library of 200,000 compounds. Viva's ASMS technology can screen any soluble protein, having already screened over 300 projects for their clients, including molecular glue. Through a combination of ASMS and SPR technologies, Viva provides a complete set of molecular glue screening and validation solutions.