On September 27, 2020, with tremendous attention, 2020 China BioMed Innovation and Investment Conference (2020 CBIIC) was successfully held in Suzhou. As the most popular session in CBIIC, “Clinical Trial Data Release of Innovative Drugs” (herein after referred to as the Session) was fully packed with participants. Key clinical data in various phases of 7 developed and marketed new drugs were released for the first time, covering therapeutic areas including diabetic foot ulcer, thyroid cancer, biofilm infection, AIDS, peptic ulcer, etc. The Session received extensive attention and appreciation from investment industry and pharmaceutical professionals.

The Session was moderated by Dr. Yang Dajun, Vice-Chairman of PhIRDA Drug R&D Specialty Committee and Chairman of the Board & CEO of Ascentage Pharma and Director Li Wenbin, Vice-Chairman of PhIRDA Clinical Research Specialty Committee and Director of Dept of Neuro-oncology, Beijing Tiantan Hospital, Capital Medical University.

Moderator of Session I: Dr. Yang Dajun

Moderator of Session II: Director Li Wenbin

7 projects focused on disease areas with urgent clinical needs and lack of effective therapy, the released data covered clinical trials results from phase I to III.

Three Projects Released Phase III Clinical Trials Results

ON101 Topline Results of Phase III MRCT in Treatment of Diabetic Foot Ulcers

Diabetic foot ulcer (DFU) is one of the most serious complications of diabetes mellitus. It has high mutilation and mortality rate and the recurrence rate could reach 30%. More than 85% of diabetic patients’ amputation are caused by DFU. For now, there are more than 7.5 million DFU patients in China, with the annual treating cost of more than 160 billion RMB.

The ON101 developed by Microbio Shanghai is now conducting phase III Multi Regional Clinical Trials according to ICH and GCP requirements, showing good safety profile and no severe adverse reaction. According to the results of phase III clinical trial, ON101 showed favorable clinical tolerance. It also indicated that the adverse event rates after treatment and drug-related adverse reactions rates were both lower than those of the control group, and no serious adverse events related to treatment drugs has ever occurred. After 16 weeks of therapy, the ulcer healing rate of the ON101 group reached 62.2%, while the control group Aquacel® Hydrofiber® was only 34.7%; ON101 therapy was not affected by ulcer or patient factors, and the healing trend was consistent; the safety level and tolerability of ON101 were similar to that of the already marketed surgical dressing.

Mr. Kuo Minliang, Sr. Vice President, Chief Director Institute of Pharmaceutical Research and Development, Microbio Shanghai

Phase III Clinical Trial Results of ACC007, a New Generation of NNRTI for HIV

AIDS is an infectious disease caused by HIV virus. It damages patients’ immune system and leads to the deficiency of immune function. In AIDS patients’ advanced stage, all kinds of serious infections and malignant tumors are more prone to occur. Now there is no fundamental solution for AIDS, and the process of AIDS can only be controlled by drugs. Non-nucleoside drugs are the first-line antiviral drugs for AIDS. About 50% of the patients infected with HIV around the world take non-nucleoside drugs, in China the figure is about 70%.

ACC007, an innovative anti-HIV drug , is a new generation of non-nucleoside reverse transcriptase inhibitors, which can quickly reduce the viral load of HIV infected patients and effectively reduce the adverse reactions of the central nervous system. Data of phase III clinical trial for 48-week indicated the experimental group and controlled group were non-inferiority and equivalence according to endpoint indicator. The incidence of adverse events in the experimental group of nervous system and psychosis categories was significantly lower than that in the controled group. NDA has been submitted in June 2020. It has a major market prospect that it may gradually replace the non-nucleoside reverse transcriptase inhibitors commonly used in domestic first-line treatment plans after launch on the market in the future. The product is expected to be launched in the market in 2020.

Mr. Wu Hao, Chief Physician of Beijing Youan Hospital, Capital Medical University

Results of Phase II-III Psoriasis Clinical Trial with Netakimab

Netakimab (Efleira®) is an original humanized anti-interleukin-17 (IL-17) monoclonal antibody developed by BIOCAD. Netakimab was binded to IL-17 and inhibits its interaction with IL-17 receptor at therapeutic concentrations. As the first original monoclonal antibody marketed in Russia, its development has attracted the attention of RMH. In 2019 and 2020, it has been approved by RMH for plaque psoriasis, active ankylosing spondylitis and psoriatic arthritis.

A multi-center phase III clinical trial (BCD-085-7/PLANETA) carried out in Russia and Belarus enrolling 213 patients with moderate to severe psoriasis with treatment period and follow-up up to 3 years. The follow -up in the twelfth week of treatment, 83.3% of patients achieved PASI improved 75%, and 1/3 of the patients were totally cured.

Ms. Meng Haijin, Shanghai Pharma-BIOCAD (HK) Limited Chief Scientific Officer (China)

Three Projects Released Phase II Clinical Trials Results

Interpretation of Research Data on Anlotinib in The Treatment of Thyroid Cancer

Thyroid cancer is a common type of cancer in clinic, which is one kind of a malignant tumor. Statistics show that the incidence rate of thyroid cancer is increasing at 20% per year.

Anlotinib Hydrochloride is an innovative new drug developed by Chiatai Tianqing Pharma, having made great achievement in thyroid cancer treatment. Two large randomized clinical trials have sufficiently proved the effectiveness of Anlotinib for inoperable local advanced or metastatic medullary thyroid carcinoma patients. The median progression free survival (mPFS) is 20.67 months for medullary thyroid carcinoma, which is significantly prolonged by 9.6 months compared with placebo treatment. The mPFS for iodine-refractory DTC is 40.54 months, significantly longer than that of placebo by 32.16 months, reaching the main endpoint.

Mr. Zheng Xiangqian, Executive Director, Department of Thyroid and Neck Oncology, Tianjin Medical University, Cancer Institute and Hospital

Phase II Results of Multitargeting Drug Conjugate TNP-2092

The use of implantable medical devices including artificial joints, central venous catheters and heart valves is becoming increasingly common, which leads to a rapidly increased demand for biofilm infections, becoming a major unmet clinical demand.

Developed by TenNor Therapeutics, TNP-2092 is a multi-targeting drug conjugate specifically designed for the treatment of medical device associated with bacterial biofilm infections. TNP-2092 exerts its biofilm bactericidal activity by synergistically inhibiting three essential drug targets associated with bacterial biofilms-RNA polymerase, DNA gyrase and topoisomerase IV. TenNor has recently completed a phase II clinical trial enrolling 120 patients with acute bacterial skin and skin structure infections. This study demonstrated the safety and efficacy of this drug product. The incidence of adverse events in the treatment was similar to vancomycin, which were mild or moderate. There were no serious adverse medical events (SAE) or death or drug-related liver dysfunction. In addition, TNP-2092 showed good efficacy. TNP-2092’s early response rate, treatment completion rate and follow-up success rate were higher than or equal to vancomycin, that includes patients infected by drug-resistant strains (MRSA and CRSA).

Mr. Ma Zhenkun, Founder & CEO, TenNor Therapeutics Limited

Novel P-CAB Create New Peptic Ulcer Treatment Paradigm Clinical Trial Data Summary of H008

Peptic ulcer mainly occurs in chronic ulcer of stomach and duodenum. Now the most common therapy is proton pump inhibitors (PPIs), but still, there are issues to be solved including slow onset and short efficacy. Carenoprazan tablets (H008) is novel, potent oral potassium ion competitive acid blocker (P-CAB) developed by Jiangsu Carephar pharmaceuticals. It has the potential to substitute for conventional PPIs, and will fill the huge clinical needs that conventional PPIs cannot meet.

The results of phase II clinical trial showed that, H008 tablets with a dose of 20mg / day had a lower incidence of overall adverse reactions and liver adverse reactions than that of 30mg / day. At 20mg / day dosage, the overall symptom remission rate reached 75.93%, which was better than that of 30mg / day dosages (66.67%). The healing rate of H008 tablets was faster than lansoprazole enteric coated capsules. At the dose of 20 mg, the time duration of the upper abdominal pain lasts the same as lansoprazole enteric coated capsules-0.43 weeks. There’s a higher increase trend of gastrin in H008 group (P < 0.0001) and most of the patients’ index could return to normal range within 2 weeks after drug withdrawal.

Ms. Xiao Yinglian, Professor and Chief Physician, The First Affiliated Hospital Sun Yat-sen University

One Project Released Phase I Clinical Trials D

The First in Human Recombinant Human Serum Albumin Presents Good Safety and Tolerance in Phase I Clinical Trial

Albumin is the most important protein in human plasma maintaining nutrition and osmotic pressure. For now, the technology of human serum albumin (HSA) is still immature and far from meeting the clinical needs. The OsrHSA developed by Wuhan Healthgen Biotechnology takes rice as the bioreactor and obtains target protein on a large scale. OsrHSA has been approved by FDA and completed phase I clinical trial in human body, showing good safety and drug tolerance.

The main results of the phase I clinical trial are: OsrHSA was safe and well tolerated; The colloid osmotic pressure significantly increased with increased OsrHSA concentration; All TEAEs were mild, not serious, and not related to treatment. No subject withdrew from the study due to a TEAE; No TEAEs related to abnormal laboratory results; No clinically significant changes in vital signs, ECGs, or physical examinations; The OsrHSA PK parameters were comparable across doses and between Asian and Non-Asian subjects; No subjects developed ADAs; No subjects developed anti-HCP antibodies post-infusion.

Mr. Song Qinhui, CMO, Wuhan Healthgen Biotechnology

The quality of projects in this session reached a new high in 2020 CBIIC. The COVID-19 pandemic did not dampen the enthusiasm of researchers and investors. We believe that, more and more serious diseases will be cured with the support of the joint force of innovation and capital.

Plenary Meeting 1

Plenary Meeting 2