China’s biotech industry is on the rise. Five of the 10 largest biotech initial public offerings worldwide in the first half of 2019 were from Chinese companies, according to the Financial Times. And new regulations on the Mainland China and Hong Kong stock exchanges allow pre-revenue biotech companies to list, further contributing further to the development of the industry.
International collaboration
To facilitate this growth, China’s biotech companies are not only looking for financial support, they’re seeking international collaborations – which represent major opportunities for western firms.
The China BioMed Innovation & Investment Conference that’s just been held in Suzhou is a major event for China’s biotech industry and has further underlined the growth of the sector.
Started four years ago to promote communication between the drug development industry and the investment world, the conference has quickly gained exposure and attracts significant attention in China. Today, it’s an important platform for bringing together thousands of biotech entrepreneurs and investors and provides a rare opportunity to get a bird’s eye view of the industry’s latest advancements.
Eight novel Chinese drugs
As usual, clinical data on the newest drugs were the center of attention. This year, the conference featured new data on eight novel Chinese drugs targeted at conditions ranging from Alzheimer’s to cancer.
Below is a brief overview of these drugs and their innovative developers:
1. Shanghai Green Valley Pharma (绿谷制药) presented data on Alzheimer’s drug GV-971, a multi-target oligosaccharide medicine derived from seaweed, developed jointly with the Ocean University of China in affiliation with the China Academy of Science. The study looked at gut bacteria causing neuroinflammation and uncovered links to the degenerative disease.
By regulating intestinal bacteria, the data showed a reduction of chemicals associated with growth and spread of inflammatory cells, resulting in major improvements in mild-to-moderate Alzheimer’s disease patients.
The drug has passed Stage 3 clinical trials and is awaiting approval from China’s National Medical Products Administration (NMPA). After more than 20 years of development, it may now be launched within a year or two.
2. Shanghai Mengke (MicuRX) Pharma (盟科医药) — a joint venture between US-based MicuRx Pharma and Shanghai Zhangjiang Biomedical Industry Venture Capital — presented new data on the development of next-generation oxazolidinone antibiotics.
The product, Contaxazole, targets multi-drug resistant gram-positive bacteria. It has overcome the bone marrow suppression toxicity of similar drugs and shows a significant effect in adult patients with complicated skin and soft tissue infections.
The first listed drug in the family, Linezolid, was launched by Pfizer and its global sales peaked at more than $1.3 billion. The clinical trials compared with Linezolid demonstrated fewer hematological adverse events with Contraxazole. An initial Phase 3 trial is now complete with promising results.
3. RemeGen (荣昌生物) presented results from clinical trials for dual-target (targeting BLyS and APRIL signalling pathways) innovative biopharmaceutical RC-18 for the treatment of systemic lupus erythematosus (SLE).
The results of a Phase 2 trial demonstrated that, at the clinical endpoint, the 48-week SLE response index (SRI-4) was significantly higher in the high-dose group than in the placebo group (79.2% vs 32.0%), with significant statistical differences.
4. The CEO of Asieris Pharma (亚虹医药), a clinical-stage biopharmaceutical company, spoke on the company’s achievements in a Phase 2 trial of the world’s first oral therapy for non-muscle invasive bladder cancer. The drug is based on the reversible MetAP2 inhibitor and slows both tumor growth and angiogenesis.
The open-label, multicenter Phase 2 trial in high-risk patients with chemotherapy/BCG perfusion failure showed that APL-1202 significantly outperformed current chemotherapy-infused drugs, with median recurrence-free survival time much-improved.
5. OncoVent (昂瑞生物), another clinical-stage Sino-western JV — this time between Shenzhen Hepalink (海普瑞药业) and Canada-based Quest Pharmtech and OncoQuest — is developing second-generation tumor immunotherapies (a combination of first-line chemotherapy + tumor vaccine + checkpoint inhibitors based on a tumor vaccine). It presented Phase 2B clinical data on Oregovomab (OV), a monoclonal mouse antibody against the tumor antigen CA125.
CA125 is one of the major blood biomarkers of ovarian cancer patients and is overexpressed on the cancer cell surface compared to normal tissue. It initiates a series of immune responses to tumor cells expressing CA125 antigen by precise combination with first-line chemotherapy (SOC).
For the 36-month Phase 2B Trial of advanced primary ovarian cancer Stage III/IV (100 patients enrolled), clinical endpoints achieved promising outcomes:
1) relative to the standard chemotherapy SOC regimen: OV combined with SOC medication showed progression-free survival (PFS) increased from 13.3 months to 41.8 months;
2) overall survival (OS): 21 deaths (SOC chemotherapy group) vs 8 deaths (SOC chemotherapy + Oregovomab), between the two groups.
There were no significant differences in the incidence of adverse events and serious adverse events. Such results suggest SOC+OV may become the first-line treatment for primary ovarian cancer patients.
6. TOT Biopharm (东曜药业), based in Suzhou, released a Phase 1 study of antibody-drug conjugate TAA013 in patients with relapsed HER2-positive breast cancer. The company is focused on clinical-stage research of drugs for a variety of cancers, including monoclonal antibody drugs, antibody-conjugated drugs, oncolytic drugs and anti-tumor medicines such as liposome drugs.
The antibody-conjugate drug TAA013, developed with recombinant humanized anti-HER2 monoclonal antibody (trastuzumab) via the linker SMCC and the microtubule inhibitor DM1, has been developed for the treatment of HER2-positive metastatic breast cancer. The current Phase 1 trial results confirm that TAA013 is safe and has seen initial efficacy in HER2-positive breast cancer patients who have received multiple anti-HER2 drugs.
7. Wuhan Binhui Biotech (滨会生物) presented Phase 1 clinical trial data on neoplastic recombination oncolytic type II herpes simplex virus (OH2) injection, the first of its kind in China.
The company is led by a Chinese returnee who participated in the T-VEC project, a genetically modified form of a herpesvirus for treating melanoma approved by the US FDA. An oncolytic virus is a type of tumor-killing virus that selectively infects and lyses tumor cells and stimulates the body to produce a specific anti-tumor immune response.
Phase 1 trials have been conducted in solid tumors including melanoma, colorectal, liver, lung, breast and head and neck cancers. The results demonstrate mild adverse events related to administration of the drug, no dose-limiting activity and good anti-tumor activity with a 78% overall disease control rate.
8. Finally, Beijing CANbridge (北海康成) demonstrated the clinical results of trials in Taiwan for innovative biopharmaceutical CAN008 (CD95 receptor/Fc fusion protein) targeting glioblastoma — the most malignant glioma in astrocytic tumors, with a first-year survival rate less than 10%. The results of Phase 1 trials show encouraging results in patients with newly-diagnosed glioblastoma who received CAN008 (400 mg/week) combined with standard RT/TMZ treatment - progression-free survival (PFS) reaching 57.1%.
Additional companies of note attending or delivering presentations at the conference included leading immuno-oncology firm BeiGene (百济神州), local PD-(L)1 drug manufacturer Shanghai Junshi Biosciences (君实生物), Innovent Biologics (信达生物制药), Sino-US immuno-oncology-focused Xynomic (徐诺药业) and companion diagnostics (CDx) developer Amoy Diagnostics (艾德生物).
Fertile ground
The China BioMed Innovation & Investment Conference attracted more than 3,500 visitors but had surprisingly little exposure in western media considering the role Chinese biotechs are increasingly playing internationally.
Many of the companies I’ve mentioned have partnered, in-licensed, are co-developing biologics or have established research centers in North America and Europe.
Chinese companies are nurturing hundreds of biotech projects, potentially providing fertile ground for international cooperation, making this a market well worth western pharmaceutical companies looking into!
To discuss opportunities with China’s biotech companies, you can contact Olexandr on olexandr.nykytyuk@intralinkgroup.com