Bio Partnering APAC 2019
Biotech Showcase Collection--Final Notification of Bio Partnering APAC 2019
路演项目：INNOVO: an open innovation program of Novo Nordisk (INNOVO: 诺和诺德的开放创新项目)
The talk will introduce Novo Nordisk’s open innovation program “INNOVO”. How we want to do drug R&D innovation with external collaboration? What we are looking for? What we can provide to external partners?
讲座将介绍诺和诺德开放创新项目---INNOVO。 介绍诺和诺德如何通过外部合作加速创新型新药研发， 希望寻找什么样的外部合作，以及诺和诺德可以为合作伙伴提供什么。
Taizhou Medical Hi-tech Industrial Park is a national-level biomedical hi-tech zone, which is jointly constructed by the Jiangsu Provincial People's Government and national ministries (Ministry of Science and Technology, Health and Welfare Committee, Chinese Medicine Authority, Food and Drug Administration) and is dedicated to the development of the bio-industry. In the past years, more than 1000 biopharmaceutical companies have been attracted to gather here, including 13 transnational 500 compulsory drug companies (AstraZeneca, BoehringerIngelheim, Nestle, etc.), domestic famous companies such as Amy Kanghuai Biopharmaceutical (Jiangsu) Co., Ltd.， Jiangsu Jindike Biotechnology Co., Ltd.，ZhongchongXinnuo Biotechnology (Taizhou) Co., Ltd. and Warwick (Jiangsu) Biological Pharmaceutical Co., Ltd.. We have introduced 55 experts of the National Thousand Talents Program, and more than 1,100 "internationally-leading and leading domestic" medical innovations have been successfully declared. We are honor to become "national new vaccines and specific diagnostic reagents."
路演项目：专业化园区在生物医药创新发展中的功能与作用Function and Impaction of Specialized Parks in the Innovation and Development of Biomedical Industries
公司简介：With robust animal data demonstrating anti-angiogenic, anti-inflammatory, and neuroprotective properties, an issued US patent, and seed money, Skyran is ready to complete IND-enabling studies.Skyran uses technology generated at the Penn State College of Medicine by Drs. Joyce Tombran-Tink and Colin Barnstable. The company is a participant in the Phase 1 Ventures program of the University City Science Center, which give us access to matching funds, a number of services, and the Philadelphia life sciences entrepreneurial community.
路演项目： Novel drugs to combat eye disease
• Skyran Biologics is an early stage company incorporated in the US that is looking to move most of its operations to China.
• Dr. Ji-Ye Wei (president) is currently working full time in China; Drs. Joyce Tombran-Tink and Colin Barnstable currently spend 3-4 months per year working in Tianjin.
• Skyran Biologics, Inc. has developed a series of eyedrop formulations to treat dry eye, uveitis, diabetic retinopathy, retinopathy of prematurity and glaucoma.
• Dry eye and antibiotic formulations are ready for manufacture.
• The diabetic retinopathy treatment is a first in class drug based on patented peptides.
公司简介：ZY TherapeuticsInc is committed to addressing this challenge Located in Research Triangle Park in North Carolina, ZY Therapeutics has an interdisciplinary R&D team and 4,500+ sf lab space right in the heart of thesoutheastbio-hub.
路演项目： Novel Lyophilized Dosage Form of Taxane Formation With Unique Drug Release Profiles
概要：Dr. Li has over 10 years of experience working on nanoparticle drug delivery technology in both academic and industry, such as Emory University, UNC Chapel Hill and Nitto Denko Technical.
Dr Li was a recognized expert in this field. He was the reviewer of NIH SBIR grant and invited reviewer of several international journals in the field of drug delivery.Dr. Li received his B.S and Ph.D from Hunan University. Dr. Li is the key inventor for the delivery technologies used in ZY Therapeutics Inc.
公司简介：Viriom Inc. is a commercial and late-stage biotech company developing novel therapies and prophylactic medicines against HIV-1 and Hepatitis B Virus (HBV). Viriom's pipeline includes: Elpida® (elsulfavirine), the best-in-class NNRTI that obtained first market authorization in 2017; novel fixed doze combination single pill regimens; extended release weekly oral formulations; and long-acting injectable therapy and prophylaxis.
Viriom is also developing a highly potent prodrug of the antiviral tenofovir to treat HIV-1 and Hepatitis B patients. Viriom combines its extended release and long-acting injectable compounds with partners’ therapies with curative potential.
Viriom is developing breakthrough medicines that are effective and affordable with the ultimate goal of curing HIV and chronic HBV infections in both developing and developed countries.
Viriom plans to massively invest in development in China and support cooperation with local pharmaceutical manufacturers and distributors.
路演项目： Development and Commercialization of Novel Anti-Infective Moleculs, including HIV and HBV, for Treatment and Prevention
概况：Type of project: HIV Chemical Drug Phrase ⅣWe have been supported by Torrey Pines Investment LLC with 50 million U.S. dollar.
Showcase title：Development and commercialization of novel anti-infective molecules, including HIV and HBV, for treatment and prevention.
公司简介：SOTIO is an international biotechnology company leading the efforts of the PPF Group, one of the largest investment groups in Central and Eastern Europe, to build a fully integrated mid-sized pharma company specialized in oncology. SOTIO is building its innovative and diversified pipeline through in-house research and development, collaborations with external partners, in-licensing, investments, and M&A.
The most advanced projects in SOTIO’s pipeline are based on the proprietary active cellular immunotherapy platform using autologous dendritic cells (DCVAC). SOTIO is testing the DCVAC product candidates in multiple clinical trials across different indications. The VIABLE study, a Phase III global pivotal DCVAC/PCa trial with 1,182 patients with metastatic, castration resistant prostate cancer has been fully recruited and will read out in 2020. Based on two randomized Ph II studies, SOTIO is currently preparing to initiate the VITALIA study, a global, registration-enabling, Phase III clinical trial with DCVAC/OvCa in relapsed platinum-sensitive ovarian cancer patients. The company also recently published positive clinical data from a Phase II clinical trial in Non-small cell lung cancer at the ASCO conference. In comparison to patients treated with chemotherapy, DCVAC/LuCa decreased the risk of death in patients with stage IV NSCLC by 46%.
In China, our affiliate SOTIO Medical Research is collaborating with leading hospitals on clinical projects treating Chinese patients with DCVAC product candidates in prostate cancer, lung cancer and in ovarian cancer. The China development activities are supported by our state-of the art GMP facilities for manufacturing of cell therapies in Beijing.
路演项目： Building an Oncology Specialty Pharma Company
概况： SOTIO recently initiated a Phase I/Ib clinical trial with its interleukin-15 superagonist SO-C101. The study will evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in selected patients with advanced/metastatic solid tumors.SOTIO is also collaborating with NBE-Therapeutics on the development of novel antibody-drug conjugate (ADC) products and with the Lead Discovery Center (LDC) and the Max Planck Society on an oncology program addressing a novel target in tumor metabolism.
Through the PPF Group, SOTIO has also made minority investments into NBE-Therapeutics and Cellestia Biotech.We seek to add to our portfolio innovative therapeutic projects in oncology with a focus on programs that are at advanced preclinical or clinical stage. In addition, for our advanced clinical stage DCVAC program we are looking for development and commercialization partners in China and other territories. SOTIO/PPF considers adding further minority investments in promising oncology companies.
In addition to biotechnology, PPF Group invests in various industries such as banking and financial services, telecommunications, mechanical engineering, insurance, and real estate. PPF’s reach spans from Europe across Asia to North America. The Group owns assets worth over EUR 45 billion (as of Dec 31, 2018). For more information about PPF visit the website www.ppf.com.
For more information about SOTIO visit the website www.sotio.com.
We, Zih Yuan Tang Co., Ltd, focus on small molecular drugs since 2005. Studying strategies basing on efficacy of Chinese herbal medicines develop small molecular drugs for therapies. Several active compounds were found for tumors, metabolic disorders, and ophthology. Candidates will be sequentially worked pre-clinical testing, and cooperated with partners.
口服糖尿病視網膜病變治療藥物GYT-088 / Oral Grug GYT-088 for Diabetic Retinopathy概况：長期糖尿病患者往往衍伸不同器官病變，包含腦部、心臟、腎臟、眼部，甚至周邊神經的病變。第一型糖尿病病患罹病15-20年後，幾乎都會產生視網膜病變。第二型糖尿病患者，約60%的病患產生視網膜病變，其中20%-30%的病患最終失明。GYT-088分離純化自治療退化性黃斑部病變的中草藥，其口服急毒性大於2000 mg/kg。以非增殖性糖尿病視網膜病變（NPDR）非人靈長類動物模型先導測試結果，顯示口服6 mg/kg GYT-088粉劑28天之後，可抑制視網膜病變病徵。在輕度非增殖性糖尿病視網膜病變，GYT-088粉劑更可抑制黃斑部水腫。從劑量倍增試驗與停藥觀察結果，更顯示GYT-088可能透過抑制新生血管，改善糖尿病視網膜病變。GYT-088具有口服治療糖尿病視網膜病變的發展潛力，對於輕度糖尿病視網膜病變病患的接受度高於現有注射治療方式。
Diabetic complications in brain, heart, kidney, eye and peripheral nervous system are from long-term diabetes. Almost of type I diabetic patients get diabetic retinopathy in 15 – 20 years. 60% type II diabetic patients get diabetic retinopathy and, then, 20% - 30% patients blind. GYT-088 is from Chinese medicinal herb for Age-related Macular Degeneration (AMD), and oral acute toxicity is over 2000 mg/kg in mice. The pilot-studying for GYT-088 in NPDR (Non-Proliferation Diabetic Retinopathy) monkey model was show that it inhibited diabetic retinopathy after GYT-088 drug-treating 28 days. In mild NPDR monkey, GYT-088 drug was capable to inhibit diabetic macular edema (DME). Mechanism of action of GYT-088 is proposed that it works anti-angiogenesis by inhibition of cell proliferation, not by directly anti-VEGF. Oral drug GYT-088 shows its high potentials for curing diabetic retinopathy, and is more easier taken by mild NPDR patients than by eye ball injection.
公司简介： STC Stem Cell Treatment & Research Institute (STRI) discovered the newly Elicited Stem Cell without side effects (STC-nEPS) with its very own technology. Free from every side effects visible in iPS (induced Pluripotent Stem Cell) and embryonic stem cell, STC-nEPS is expected to bring the quality of life for mankind into a whole new paradigm.
路演项目： Newly Elicited Pluripotent stem cells without side effects
概况：bBHC is life science company. We world’s first developed pluripotent stem cells without side effects which is called nEPS. Also we successfully differentiated nEPS into human pancreatic beta cell, hepatocyte, neurocyte, chondrocyte, osteoblast, kidney cell and T-cell.
bBHC is corporation to develop human tissues and organs.
公司简介：Bionetix, Inc. (“Bionetix”) is a development stage biotech devoted to the development of innovative small molecule based new drugs. With the aim of providing novel solutions to patients with high unmet medical needs, Bionetix was founded in 2017 and has completed 3 rounds of successful fund-raising campaigns. As a result of the fund-raising, Bionetix has raised about 15M USD until present and developing 2 IND-ready stage candidates (NTX-101, topical glaucoma treatment and NTX-301 oral targeted anti-cancer agent) and other early stage programs.The combination of unique operation system and industrial expertise of Bionetix team enables fast development of the 2 preclinical programs and efficient identification and incubation of novel innovative early stage programs. In 2019, 2 IND applications for bothe NTX-101 and 301 will be submitted and 2 phase I clinical trials are expected in early 2020.
路演项目 ：NTX-101, a novel topical glaucoma treatment with direct neuroprotective effects
概况： Normal IOP glaucoma is a severe chronic ocular disease affecting many people in east Asian countries, especially, China, Korea and Japan. In contrast to the primary open angle glaucoma (“POAG”) where IOP lowering medications are effectively protecting the optic nerves of patients, optic nerves and other ocular tissues of normal IOP glaucoma patients cannot be protected by simply lowering IOP. Several clinical studies employing various IOP lowering agents has failed to protect the optic nerve damage in normal IOP glaucoma patients and has emphasized the needs for developing direct neuroprotective agent.
NTX-101 is a topically applied 11beta-HSD1 inhibitor which normalized cortisol metabolism in the glaucomatous eye. Excess cortisol in glaucomatous ocular tissue plays several negative roles in normal IOP glaucoma – excess cortisol blocks the activation of neuro/tissue protection mechanism against ischemic damages and exacerbate the damages in glaucomatous eye. By normalizing the local cortisol concentration in the eye, NTX-101 recovers the innate neuro/tissue protection mechanism and directly protects the optic nerve and other tissues from glaucomatous damage. Several animal studies, including non-human primate glaucoma model study show that NTX-101 possesses a good direct neuroprotective effect that exceeds the neuroprotective effects of Alphagan.
Bionetix owns global exclusive rights for NTX-101 and has completed IND-enabling studies for NTX-101. The initial IND submission is scheduled to be in this November and initial phase I clinical trial will be initiated in early 2020. Bionetix is seeking partners interested in NTX-101 and is open for the various collaboration opportunities.
公司简介：Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The company is investing in indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Collaborations and partnerships are important parts of Medivir's business model and the drug development as well as the commercialization is conducted either by Medivir or in partnership. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's Small Cap list. More information about Medivir can be found at www.medivir.com
路演项目：Opportunities with special focus for China in Medivir’s broad and robust development pipeline
概况：Medivir has a broad and robust development pipeline with 4 projects in clinical phase and one project with the candidate drug selected. All but one project is within oncology, whereas the other is in osteoarthritis. The focus of the presentation will be the most interest for the Chinese market:
1) MIV-818 is a liver-targeted nucleotide aimed for treatment of Hepatic Cell Carcinoma and other liver cancers currently in phase 1. Medivir aims to take MIV-818 through development and approval in US/EU and is looking for a collaboration partner for development in Asia.
2) MIV-711 is a cathepsin-K inhibitor for the treatment of osteoarthritis (OA) that have completed phase 2 and is ready to initiate phase 3. It has the potential to be the first Disease-Modifying Agent in OA. Medivir is looking for a global partner who wil develop and commercialize MIV-711
路演项目：Terns – An Emerging Global Leader in the Development of Molecularly-Ttargeted Drugs and Combination Therapies to Treat Liver Disease and Liver cancer.
Jiangsu Atom Bioscience & Pharmaceutical Co. Ltd. (Atom Bioscience) was founded in 2012 in China. The executive team is primarily from the US and has extensive experience in the pharmaceutical industry. Atom Bioscience has completed series A and A+ financing and has begun round B seeking $23 million to support two phase 2 clinical trials in gout and pre-clinical pipelines from NASH and anti-gastric cancer.
路演项目：具有全球商业价值的痛风和其它创新药物的研发Development of A Potent and Safe Gout Drug ABP-671 and Other Programs概况：新元素医药拥有多种项目组合，其中拥有全球自主知识产权的抗痛风创新药ABP-671（促尿酸排泄药物）已在美国开展1期临床试验。痛风由长期高尿酸血症所引起，全球痛风患者超过5500万，现有药物有十分严重的毒副作用，全球痛风市场存在着巨大的、未满足的临床需求。ABP-671临床前研究显示，该药在动物体内促尿酸排泄效果远远优于已上市的同类产品，且未有肝脏、肾脏、胃肠道和心血管等毒副作用，成药性良好。ABP-671现于美国开展1期临床研究，临床数据显示，ABP-671在0.1 mg单剂量给药即出现药效，0.5 mg单剂量给药可显著降低受试者血尿酸水平，血尿酸下降平均比率达32.7%，而在其它高剂量组单次给药，最大下降比率有83%，远优于现有抗痛风药物，且该药物拥有良好的人体PK参数。该药可能克服目前痛风药物面临的毒性大、患者无法长期服用的弊病，有望进入国际、国内市场，为广大痛风患者长期用药带来福音。公司其他在研的管线产品，如适用于三类癌症first-in-class抗癌药物和治疗非酒精性脂肪肝（NASH）的创新药也将在近期进入临床前或临床研究。新元素医药计划在2021年在美国或是香港IPO。
Currently, our candidate ABP-671, an URAT1 inhibitor, is under Phase 1b trials for treatment of gout and uncontrolled gout in the US. There are over 40 million gout patients worldwide. However, the current medications for gout do not meet this market due to the severe side effects of current drugs.
ABP-671 has demonstrated great efficacy in animal models, excellent safety profiles, strong enzymatic stability, good PK, and several other promising characteristics in pre-clinical studies. Based on recent results from Phase 1a human study, ABP-671 showed superior serum uric acid reduction at very low dose levels. Its efficacy is much better than any marketed gout drugs including URAT1 inhibitors including Benzbromarone, Zurampic, and xanthine oxidase inhibitors such as Allopurinol and Uloric (Febuxostat).
Furthermore in our pipeline, ABP-6016 shows remarkable potency for treatment of NASH with a promising safety profile in animal studies and is currently under pre-clinical development. ABP-6016 is expected to enter Phase 1 US clinical trials in Q4 2020. Candidate ABP-431 is additionally under pre-clinical study for treatment of gastric, colon, and breast cancers; it is scheduled for clinical trials in the US next year. Atom Bioscience is planning to IPO in the US or HongKong in 2021.
MITRO Biotech Co., Ltd. is the first molecular imaging contract research organization (MI-CRO) company in China. By applying advanced radiolabeling and in vivo molecular imaging techniques, MITRO provides domestic and overseas customers with integrated new drug development solutions and outsourcing contract research services, covering drug screening, bio-distribution, pharmacokinetics and pharmacodynamics. MITRO offers translational research on different subjects, from nude mice, rats, monkeys to humans. MITRO is dedicated to exploring disease mechanisms, developing drugs for diagnosis and treatment, and evaluating therapeutic effects by focusing on major diseases (including tumor, coronary heart disease, Alzheimer's disease, Parkinson's disease, epilepsy and rheumatic and immunological diseases) and research frontiers (including receptor, gene expression and stem cell research).
路演项目: The Application of Molecular Imaging in Drug Discovery
DenovoBiopharma is a privately held biotech company providing a novel biomarker solution to personalize drug development. The core technology is the industry's first platform and algorithm to perform de novo genomic biomarker discovery retrospectively using archived clinical samples. This technology is especially useful for late stage clinical drugs that have completed trials with unsatisfactory efficacy. By identifying biomarkers correlated to patients' responsiveness to drug candidates retrospectively, our 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. Our platform can be broadly applied to biomarker discovery in many therapeutic areas, such as oncology, metabolic, cardiology, immunology and neurology.
A disrupted model to develop first in class drugs globally with precision driven by big data
• 索元生物关注于缺乏有效药物满足患者需求，以及存在获得丰厚回报机会的领域进行开发；• 知识产权保护（药物与新型生物标记物相结合）期可长达20年，而研发周期得以节约，从而保证了公司获得长期、稳定的回报丰富的首创新药（First-in-Class）研发管线
Adagene (Suzhou China) is a clinical stage biotech company with innovative antibody discovery and engineering technologies. Utilizing its proprietary Dynamic Precision Library Platform (DPL), Adagene is developing immuno-oncology antibodies against novel epitopes that give unique product profiles that have potential to succeed where other groups have failed.
Adagene is showcasing its exceptional antibody engineering capabilities by building franchises of products with multi-specific antibodies that are cross-species reactive to accurately find the correct structural relationship and drug combinations to find the ideal therapeutic. Also, Adagene is developing a third-generation technology to enhance the therapeutic window for antibodies.
Adagene has received notification from the FDA to proceed on its IND application to study its lead product in patients with advanced solid tumors and non-Hodgkin lymphoma which exhibits robust single agent and combination activity in multiple pre-clinical models. Also Adagene plans to file INDs in the Australia and China in mid-2018. Adagene’s second and third products are currently anticipated filing global INDs in 2019 and 2020.
The company’s management team is composed of industry veterans with proven track record in therapeutic antibody R&D. Adagene is backed by top notch global venture funds such as F-Prime Capital Partners, Eight Roads Ventures, 6 Dimensions Capital, GP Healthcare Capital, New World TMT Ltd and Sequoia China. The company has raised over $85 million through its series A to C financing.
路演项目： A Next Generation Antibody Masking Technology
路演项目： Novel Antibody Therapeutics Targeting TME
路演项目： AB-106 新一代强效ROS1/NTRK抑制剂：早期研究结果及未来研究展望
AnHeart Therapeutics introduced a highly efficient ROS1/NTRK dual-target inhibitor AB-106 from Japan Daiichi Sankyo at the end of 2018. The product has completed phase I clinical trials in Japan and the United States. The results indicate significant anticancer effect of the product. At present, AB-106 is being prepared for phase II clinical trials in China and the United States in the first quarter of 2020. These trials will expeditiously demonstrate AB-106 can deliver the therapeutic effects safely, and be easily administered at relatively low cost.
公司简介：AUM Biosciences (AUM) is an oncology-focused Asian biotechnology company committed to developing affordable cancer therapies. Dedicated to unlocking the value in innovation, AUM harnesses the power of precision medicine and digital health to support patients, physicians and partners. AUM focuses on early-stage development of innovative treatment of cancers prevalent in Asia with the potential to address global markets.Led by a highly-experienced management team with over 100 years of oncology drug development experience combined, AUM develops potent and highly selective therapeutics in oncology, with an aim to change the drug development paradigm by implementing a holistic approach to developing drugs.Headquartered in Singapore, AUM is strategically positioned to work, partner and collaborate with leading research institutes, clinicians and pharmaceutical companies globally. AUM is the recipient of Frost & Sullivan’s 2019 Asia-Pacific Biotech Entrepreneurial Company of the Year
路演项目：A Brief introduction of AUM and Brief introduction about AUM001 and AUM302
AUM001 is a highly specific Mnk1/2 inhibitor, a key enzyme in cancer cells that drives growth and proliferation when activated. Initial results showed that the drug was well-tolerated when used to treat patients with a range of liquid and solid tumours. As of August 2019, a Phase I Multiple Ascending Dose (MAD) trial for AUM001 has commenced in Australia. The trial will investigate the safety, tolerability and drug distribution kinetics of different doses of AUM001 and will help determine the optimal dose to take forward into cancer patients. AUM Biosciences licensed global rights to develop, commercialise and manufacture AUM001 from Singapore’s Experimental Therapeutics Center of the Agency for Science, Technology and Research (A*STAR) in December 2018.
AUM302 is the first ‘oral kinase inhibitor’ to uniquely inhibit three critical cancer targets (pan-PIM kinase, pan-PI3K and mTOR inhibition) via a single molecule. Kinase inhibitors are drugs that have played an increasingly prominent role in the treatment of cancer and inhibiting these three targets has been shown to be more effective than inhibiting them alone. AUM Biosciences recently announced a global license agreement with Inflection Biosciences for exclusive worldwide rights to develop, manufacture and commercialise AUM302, the lead candidate of the IBL-300 series of molecules. AUM302 is currently in the pre-clinical stage of development, with activity predicted across a range of cancers. It has been evaluated in over 700 cancer cell lines and has shown potential for clinical development in breast cancer, lung cancer, leukaemia and neuroblastoma.
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