On September 27-29, 2020, 4 roadshow sessions for non-listed company projects were successfully held in 2020 China BioMed Innovation and Investment Conference (2020 CBIIC). A total number of 34 projects were presented in the sessions, covering fields of solid tumors, hematological tumors, orthopedics, metabolic system and antiviral as well as R&D platforms for biological drugs and small molecule drugs. The roadshow was fully packed and received lots of attention from the investors.

Non-listed Company Roadshow

4 experts from well-known investment companies, institutions and medical information companies introduced the status and opportunities on domestic pharmaceutical innovation market from views of policy and R&D trend.

Keynote Speakers:

Mr. Zhang Buyong, Chief Researcher & General Manager of MENET (upper left)

Mr. Xu Jiaxi, Managing Director and Deputy Head of Research in CIS (upper right)

Prof. Hu Yuanjia, Associate Professor & Deputy Director of Clinical Research Center, State Ky Laboratory of Quality Research in Chinese Medicine of University of Macau (bottom left)

Mr. Zhou Jun, Vice President of Hangzhou AIMed Technology (bottom right)

Mr. Zhang Buyong, General Manager of MENET, introduced the performance of China’s innovative drug market under the influence of a series of new policies through detailed data comparison. Mr. Xu Jiaxi, Managing Director and Deputy Head of Research in CIS, delivered a speech on “New Model under ‘New Normal’, Takeways for Healthcare Investors”, thoroughly analyzed the progress that pharmaceutical innovation companies had made in secondary market in recent years and illustrated the type of companies that capital market interested in. Prof. Hu Yuanjia from University of Macau introduced China’s pharmaceutical innovation based on patent transformation in perspective of the development of times. Mr. Zhou Jun, Vice President of Hangzhou AIMed Technology introduced what benefit and support could be brought to pharmaceutical companies, healthcare professionals and patients by the implementation of intelligent medical robots.

1.      Oncology is Still Receiving Attention

18 oncology R&D companies presented in the roadshow session, the market attention continues to grow.

ACT001 is a small molecule developed by Accendatech, it can across the BBB and demonstrated excellent safety profile. The patient enrolled in March 2017, and reached to complete response after single drug treatment with ACT001 for 19 months. Up to date, the patient continues to take ACT001, and no recurrence was observed. ACT001 obtained the orphan drug designation (ODD) in USA and Europe in 2017 and 2018, respectively, and phase II in USA and China will be carried on separately soon.

Zhejiang NovoCodex Biopharmaceuticals is committed to the discovery and development of macromolecular drugs based on unnatural amino acids-introduced site-specific conjugation. The phase I clinical study of the leading project, NCB001 (or ARX788, an anti-HER2 ADC), was recently completed. NCB001 showed good safety and efficacy in subjects with advanced breast cancer (BC). As of July 16, 2020, among 59 enrolled BC subjects, there were 26 best response of PR, 29 SD and 4 PD. The ORR of 1.5 mg/kg group (recommended dose of phase II/III clinical study) was 68.4% (13/19) with few cases of grade 3 or above drug related adverse events. Encouraged by the good outcome of NCB001 in BC Phase I study, the phase II/III clinical study of NCB-001 has been initiated.

There are currently eight antineoplastic drugs in different R&D stages in Genhouse R&D pipeline, among which GH21 project is the most advanced and is expected to submit new drug application in 2023. GH21 is a small molecule allosteric inhibitor with clear mechanism of action and good safety. It can be combined with a variety of anti-tumor drugs and is expected to treat a variety of different types of tumors, with great market value and social benefits.

Elpiscience is a clinical stage biopharmaceutical company focusing on cancer immunotherapy. The company is committed to leading the innovation and development of the next generation of cancer immunotherapies for the benefit of cancer patients worldwide. Elpiscience’s first therapeutic product ES101, is in Phase I clinical study. ES101 is a “First-in-Class” bispecific antibody, targeting 4-1BB and PD-L1. The unique design of the molecule allows for PD-L1 binding dependent activation of 4-1BB, which simultaneously “Removes the brakes and steps on the gas”, thereby inducing a stronger anti-tumor immunity.

2.      Outstanding Products with Excellent Performance

Dr. Chen Xiaoguang, Professor of Institute of Materia Medica of Chinese Academy of Medical Sciences & Peking Union Medical College, introduced the novel drug R&D of metabolic checkpoint regulators in treatment of major chronic diseases. Abnormal metabolic checkpoints are the primary driving force of occurrence and progression of chronic diseases including tumor and autoimmune. Additionally, these are also related to aging. Targeting the metabolic checkpoints will make the treatment of major chronic diseases enter a new era of metabolic therapy and make benefits for patients.

Epivotide, which was developed by Wuhan Yicheng Biotechnology, is a cell-penetrating peptide inhibitor specifically targeting PI3K isoform p55PIK and shows excellent effectiveness with low side-effects in treating inflammation and autoimmune diseases. Phase I clinical study of Epivotide Drop (First-in-class drug) to treat rhinitis has been completed. Pre-IND study of second Epivotide drug for eye diseases has been finished and its clinical trial is expected to begin early next year.

Immunecent Biotechnology focuses on SLE. Immunecent developed a differentiated humanized antibody (IMN-01) binding to IFNAR1. Importantly, IMN-01 blocks pathogenic IFN-I including IFN-ω and all IFN-α subtypes but not non-pathogenic IFN-β. This will preserve the antiviral function of IFN-β and minimize the viral infection side effects. Additionally, IMN-01 binds to a unique epitope on IFNAR1 which have been covered in our patent. In summary, IMN-01 is promising antibody for SLE treatment with reduced side effect and robust international patent protection.

Biobone Biotech Limited is an innovation company committed to develop and promote medical product in bone repair area. Biobone Biotech is a holding subsidiary of Link Health Pharma. Company’s representative product is the first cartilage regeneration peptide drug LH021 and the next generation bone graft GuXinSheng respectively. Both products are in clinical development stage, LH021 is the first DMOAD (Disease-modifying OA Drug) that in clinical research stage in China and GuXingSheng will be launched in 2021.

3. Multiple New Drug R&D Technology Platform Developed by Companies

Thousand Oaks Biopharmaceuticals was established by Dr. Luo Shun, famous expert in biopharmaceutical, and most of chief executive were from Genentech, Amgen, Merck etc.. Thousand Oaks Pharmaceuticals committed to providing high quality CDMO services and developing customized cell cultural medium and PD to speed biologics development to clinic. The company combines expertise in biology, cell cultural medium development, and extensive CDMO service capabilities in China to enhance its full range CDMO services that are optimized for biologics pre-clinical and commercial production.

PKU SH is a fully integrated biologics CRO/CDMO dedicated to the whole industry chain from research to commercialization. It built a new 1700 square meter R&D and pilot production base in Shanghai's Zhangjiang International Medical Park, providing standalone technical services for various stages of biological drug development and also end to end support for R&D from discovery to clinical studies.

Guangdong Raffles PharmaTech takes the innovative route as the core, systematically integrate enzyme catalysis, organic catalysis, continuous flow microreaction etc, which meet the requirements of industrialization, drug application, safety, environmental protection and other aspects, and also meet the development trend of the international community for green pharmaceutical industry.

4. Company Roadshow Rings the Bell for Independent Innovation

Boan Biotech is a fully-integrated biopharmaceutical company. The company specializes in the research & development, manufacturing and commercialization of therapeutic antibodies, which are mainly focused on key therapeutic areas such as oncology, diabetes and immunological diseases.

Denovo Biopharma is a clinical stage biopharmaceutical company that applies novel biomarker approaches to re-evaluate medicines that have failed in broad patient populations. By identifying biomarkers correlated to patients' responsiveness to drug candidates retrospectively, Denovo Biopharma’s technology enables biotech and pharmaceutical companies to design new clinical trials in a targeted patient population to achieve significant efficacy and/or less adverse effects.

Impact Therapeutics is a privately held clinical-stage biopharmaceutical company incorporated in Nanjing, China, dedicated to the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality. Impact has made tremendous progress in several novel drug R&D projects, including PARP inhibitor, Wee1 inhibitor, other novel DDR agents and Hedgehog pathway inhibitor. Till now, all products of Impact Therapeutics are independently developed, and the company holds global rights and interests.