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2013/11/15

Hua Medicine Breaking New Ground

This month’s Innovation That Matters features an interview Dr. Li Chen, CEO of Hua Medicine.  Chen and his colleagues at Hua had much to celebrate in November as their novel Type II diabetes treatment entered clinical trials in China. This milestone marks the first case in China for a  “First-in-Man” study of a novel chemical entity with an entirely new mechanism of action for diabetes treatment. Congratulations on entering Phase I.  To start, could you provide some insights into the drug and the trial? Sure. We licensed the drug, a fourth-generation glucokinase activator, from Roche in December 2011, and since then have worked with our partners to enter the clinic. Having succeeded in these tasks, we’ve now begun enrolling diabetes patients in a Phase I study. It is the first time a personalized medicine approach has been tested in Type II diabetes in China, so we’re very excited by our progress. How has the novel nature of the drug affected the regulatory process? It’s meant we’ve been breaking new ground. The Chinese FDA assessed our submission under its special review channel for innovative drugs, and the process was rigorous yet swift. We think it’s a significant step forward in regulatory oversight of drugs with novel mechanism of actions. Our use of a “Collaborative Innovation” operating model also helped us advance the drug quickly. That sounds interesting. Could you explain the “Collaborative Innovation” approach? “Collaborative Innovation” harnesses the growing drug discovery and development ecosystem in China to deliver products that improve patient outcomes. So, for example, we have partnered with WuXi for clinical drug supply and other services. We believe that tapping into our collective capabilities is central to the growth and internationalization of the Chinese pharmaceutical industry. Ultimately, it is the best way to improve the lives of patients.

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2013/10/21

A Conversation with Carl Firth, CEO of ASLAN Pharmaceuticals

Since setting up in 2010, Singapore-based ASLAN Pharmaceuticals has shaken up drug development with its innovative, virtual approach to advancing therapeutic candidates. Fresh from winning the Red Herring Top 100 Asia Award 2013, ASLAN CEO Dr. Carl Firth spoke about the company’s model, drug development in Asia, and what to look out for in the coming years. What motivated you to found ASLAN? My co-founders and I spent most of our careers working in big pharma. Though over the years we’ve heard a lot about changing development paradigms and approaches, barring a few notable examples, the industry is developing drugs today in roughly the same way it was 20 years ago. We set up ASLAN to execute creative development strategies leveraging high quality, innovative clinical centers in Asia. What is ASLAN’s business/development model, and what are the benefits of this approach? ASLAN aims to create value in early clinical development. We in-license preclinical and phase 1 compounds from global pharma and biotech companies, typically acquiring global rights, and focus development on diseases more prevalent in Asia, like gastric cancer. We develop these drugs through clinical proof of concept before licensing to a pharma partner for global phase 3 development and commercialization. By working in Asia with an innovative model, we believe we can develop drugs more creatively, faster and more efficiently than our peers. As a virtual company, how would you rate the standard of service providers in Asia? We’ve always believed that a small company like ASLAN can be more creative, agile and efficient than a larger one, but that means we are also critically dependent on our partners to help us execute our clinical and manufacturing strategy. Traditionally, Asia has been a center for late-stage clinical studies and large -scale manufacturing, so though there are many service providers in Asia today, only a handful have experience with early-stage clinical studies – typically the more established players in China, Taiwan and India. For instance, Wuxi AppTec supports our clinical supply manufacturing for all our compounds. The quality of the service provided is generally very high, but it does help that we have a team on the ground. Trying to run a clinical study remotely across multiple time zones without a local team would be challenging. Where does China fit in your plans? Though we have no plans to conduct global phase 3 studies – we will rely on our partners to help us there – we are planning to conduct late-stage development in selected Asian countries, including China. We have set up an office in Taiwan and are setting up an office in China. Through these, we plan to conduct clinical development to support regional studies and – for some of our compounds – to carry out local development activities. Related Links: ASLAN Pharmaceuticals secures US$22M in Series B financing led by Cenova Ventures (Source: ASLAN Pharmaceuticals)  

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2013/10/03

WuXi Partners with QB3 on its New Incubator in San Francisco

WuXi is partnering with QB3 on its new incubator in San Francisco. The 24,000-square foot biosciences incubator is the latest expansion of the highly-successful QB3 program, which supports entrepreneurs with cutting-edge science. We sat down with Associate Director of QB3 and General Manager of QB3 Partners, Douglas Crawford, to talk about the partnership and expansion. QUESTION: Can you provide some background on QB3 and what you do? CRAWFORD: QB3 was set up in 2000 to foster the development of innovative startups. We do this in a variety of ways, but I’d single out two as being particularly important. Firstly, our industry partners help QB3 startups identify technical risks, which is a big challenge for young companies. And secondly, we help finance research through our venture fund, Mission Bay Capital. We’re really pleased to have WuXi’s support in both these areas. QUESTION: How does the new expansion help you further this mission? CRAWFORD: It gives us more space! We already have two facilities near the UCSF Mission Bay campus, and another two in Berkeley, but to support more great science we need another site. At 24,000-square foot the new incubator, QB3@953, is our biggest yet. When we’re at capacity we expect to house up to 30 startups. Ultimately, that means we’re supporting a lot more innovative work than we could before. QUESTION: How has your experience with earlier incubators shaped QB3@953? CRAWFORD: We’ve become even more focused on helping startups make the most of every dollar. So, entrepreneurs can start by renting just one bench, and then pay for space in super-freezers or use of centrifuges as and when they need to. It’s about flexibility, really. And we try to leverage collective scale to lower costs and simplify logistics too. Lab gloves are dispensed centrally, for example. Anything that frees up great researchers to focus on doing innovative science is a good thing. Related Links: QB3 to Collaborate with Johnson & Johnson Innovation on New Incubator (Source: The Wall Street Journal) QB3, partnership to open new, large life sciences incubator (Source: San Francisco Business Times)

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2013/10/01

An Interview with Dr. Lawson Macartney, CEO of Ambrx Pharmaceuticals

An interview with Dr. Lawson Macartney, CEO of Ambrx Pharmaceuticals, on the co-development of an ADC therapeutic for HER2-Positive breast for cancer in China.   THE NEWS: This month’s Inside Perspective features Dr. Lawson Macartney, CEO of Ambrx Pharmaceuticals. Ambrx recently announced a deal in which it would co-development a therapeutic for HER2-positive breast cancer with China-based Zhejian Medicine Co. WuXi will handle preclinical, clinical trials and toxin manufacturing. ZMC will hold commercial rights to the compound in China, Ambrx holds rights in the rest of the world, collecting royalties on Chinese sales. QUESTION: Ambrx has an industry-leading ADC technology platform and a number of notable partnerships with western pharmas like Merck and BMS. Why the expansion into China?   Macartney: Accessing the China market is becoming an increasingly important objective within Ambrx. Developing and manufacturing biologics within China to world class standards is a relatively new paradigm. We look forward to integrating these efforts into our global development strategy. QUESTION:From a business perspective, this three-party deal is very creative and intriguing. Could you explain the strategy?  Macartney: This partnership is unique. It allows us to team up with China’s leading pharmaceutical and CRO companies to efficiently access the China market, an opportunity that we would otherwise miss if we were not to combine our respective efforts. This is an innovative deal structure that allows us to gain access to China while also reducing time and R&D costs. QUESTION: What’s one thing you learned putting together this deal that could benefit other companies looking to develop drugs to sell in China? Macartney: Build strong relationships with those that you do business with. This will better enable the collaborations to overcome obstacles and take advantage of opportunities. Related Links: Expediting Development of Biologics in China: From Strategy to Regulatory Expectations and Beyond Ambrx and Zhejiang Medicine Co. Ltd. Form Collaboration to Develop and Commercialize Ambrx’s Antibody Drug Conjugate for Breast Cancer

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2013/09/26

Congratulations to Foundation Medicine for a Successful IPO

Our warm congratulations to Foundation Medicine on the important milestone of initial public offerings! Located in Cambridge, Massachusetts, Foundation Medicine is a cancer diagnostic biotech company that enables doctors to recommend treatment options for cancer patients based on their genetic profile. WuXi Corporate Venture Fund participated in its Series B financing in 2012 to help furthering its mission of transforming cancer care through deeper understanding of the underlying genomic changes. On the first day of its market debut on September 24, Foundation Medicine shares rose as much as 89 percent, raising about $106 million to expand its commercial and laboratory operations, and to fund clinical studies. The strong market response reflects great public confidence in the company’s innovative approaches, and the potential of genomics in the treatment of diseases. Congratulations, and we wish Foundation Medicine continued success in bringing better medicines closer to patients! Related Links:  Steve Jobs’ Final Vision Is Coming True Thanks (In Part) To Bill Gates And Google (Source: Business Insider) Foundation Medicine shares rise 89 percent in market debut (Source: Reuters)  Foundation Medicine Expands Series B Financing to $56 Million

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