来源:SCRIP杂志 2014.6.4

　　China is home to the world's largest aging population – approximately 200 million people over the age of 60. As such, chronic diseases such as diabetes and cancer have been the target for big pharma companies in the country. Among them is Betta Pharma (Betta), a private company founded in 2003 by Dr Lieming Ding, a former board-certified physician in the US, and his partners.
　　The Hangzhou-based company, which is ready for an initial public offering in China, first caught the media's attention in July 2011 when it launched China's first proprietary oncology drug Conmana (icotinib) to treat non-small cell lung cancer. In May 2013, Betta again appeared in the media because it formed a joint venture with Amgen to bring in Amgen's colorectal cancer treatment Vectibix (panitumumab), for the Chinese market.
　　In December 2013, Amgen-Betta filed an imported drug license to China's State Food and Drug Administration (SFDA). It also has set up a team to start early-stage marketing for Vectibix. A few blocks away from its office, Betta's new facility is under construction, aiming to triple the output value of Conmana to CNY7.5bn ($1.2bn) per year.
　　But for Betta CEO Lieming Ding, these considerable advances are just a very small part of his work. "Conmana's success is a good start for Betta, but to become a successful company, we have to plan for the future," he says during an exclusive interview with Scrip Asia 100.
　　Indeed, within Betta's pipeline, there are seven compounds currently in preclinical studies, including BPI-3000 for type II diabetes, BPI-5000 for anemia, a topical cream called BPI-2009C for psoriasis, as well as four oncology compounds – BPI-7000, BPI-15000, BPI-16000 and BPI-17000.
　　In December, Betta filed an investigational new drug application for BPI-9000, a kinase inhibitor of c-Met/Axl to treat cancer. "Oncology is our main focus. It's not because we are not capable of moving onto other diseases, but we want to maximize our strength in this sector," Dr Ding explains.
　　But what about that skin disease cream?
　　"It's actually a coincidental, delightful finding during our studies on an oncology compound. This is what makes science interesting," Dr Ding beams, but declines to elaborate on the surrounding circumstances.
　　Sales of Conmana reached CNY475m in 2013, up by 58% from CNY300m in 2012. In 2014, Dr Ding expects a 36% increase from 2013 to CNY650m.
　　Priced at CNY2750 per unit (125mg*21 tablets), Conmana no doubt poses a strong challenge to its two foreign rivals – Iressa (gefitinib) from AstraZeneca with a price tag of CNY5126 (250mg*10 tablets), and Roche's Tarceva (erlotinib) for CNY4550 (150mg*7 tablets). In fact, Dr Ding confirms Conmana users have so far reached 40,000 nationwide, more than Tarceva users, but still lagging behind the number of Iressa users.
　　Like Iressa and Tarceva, Conmana also has a patient assistance program (PAP), according to which any patient using Conmana for over six months can get the drug for free for further treatment as long as they have a proven track record that shows Conmana is effective for them.
　　"As the data showed, each new Conmana user has about a 34% chance of becoming a member of this program, which is another way to prove the efficacy of the drug," Dr Ding says.
　　However, he added, the sooner the company can ensure Conmana is available on China's national healthcare scheme (NHS), the better, as Betta now gives away about half of its production for free through PAP.
　　"We are glad to see Conmana can help so many patients, but honestly PAP also burdens a start-up like us: that's why we are trying to lobby Conmana into the NHS, through which patients can still afford the drug. It's also a more sustainable solution for us," he explains.
　　So far, Conmana is covered by the local healthcare scheme of Zhejiang province, meaning patients in Zhejiang province pay about 20% for the drug, while the local government pays the rest. Iressa and Tarceva have less of an advantage, as they are covered only in Guangzhou, the capital city of Guangdong province.
　　Despite his best wishes, Dr Ding admits that getting Conmana into the NHS is no easy task and until then, Conmana, just like any other drugs, has to go through the time-consuming, complicated process of government procurement in each province to get into local hospitals. From Dr Ding's point of view, this is not necessary at all.
　　"The government procurement tendering system aims to maintain a fair market and control the drug prices, and I think it makes sense for generic drugs, which are supplied by many manufacturers. But for a novel drug like Conmana, it is not necessary since the government authorized the company to set the price for the novel drug at their own strategy and valuation. It is meaningless to go through the system except for long delay to the market. Since China used to have only generic drugs we have to adjust our policy as China is going to have its own novel drugs," he said.
　　As a member of 12 th National People's Congress (NPC), Dr Ding proposed to make new policies to meet the evolving domestic drug industry, and to encourage innovation. In China, it takes a long time for a new drug to get into hospitals. In Conmana's case, "it is only available in less than 5% of big hospitals in the country although it had been launched for over two years," Dr Ding laments.
　　But for drug makers in China, both Chinese and multinationals, more serious challenges lie in sales, especially after the GlaxoSmithKline bribery scandal which emerged a year ago. Dr Ding said the scandal did affect Conmana sales at the beginning, as even making an appointment with doctors became like "mission impossible".
　　"It wasn't until later in 2013 that our sales started to pick up again as people began to think more rationally. Sales representatives are essential because they bridge companies and doctors and they bring better, more effective therapies to patients," he says, adding that Betta and its JV with Amgen has reinforced its compliance strategy.
　　"We made it clear that bribery is absolutely not allowed," he says.
　　China has expanded its bribery probe. Aside from GSK China, whose senior managers, including former general manager Mark Reilly, have been officially accused by the Chinese police of corruption, Chinese officials have also visited Chinese regional offices of Roche, Lilly and Novo Nordisk.
　　R&D Partners
　　Like multinationals, Betta, too, is actively seeking partners in the academic area to strengthen its R&D capability. So far, it has partnered with some universities and research institutes for early-stage research programs for possible oncology treatments.
　　"It's a win-win partnership as we can also help to commercialize the programs of our academic partners," Dr Ding says.However, he added that currently Betta has no urgent plan to invest in the bio sector, beyond its JV with Amgen.
　　"Macromolecular drugs indeed are prospective, that's part of the reason we formed the JV with Amgen. But they are very different from small molecular drugs in terms of manufacturing and R&D. Frankly speaking, I think Betta is not ready to do it alone at this stage," Dr Ding says, but adds that the company is open for opportunities including co-development, contract manufacturing and marketing.
　　Using qualified contract research organizations to manufacture monoclonal antibodies (MAbs) has recently been favored by some drug companies to avoid huge investment in building highly demanding manufacturing facilities. For example, Taipei-based TaiMed Biologics partnered with Shanghai-based Wuxi Apptec to manufacture its HIV treatment ibalizumab, and Jiangsu-based Hengrui chose ChemPartner (also Shanghai-based) to be its MAb supplier.
　　For Betta, opportunities also lie in global in-licensing and out-licensing projects, forming new JVs and seeking foreign partners to bring Conmana to the Western market. "Lung cancer is the most common cancer worldwide and we think Conmana may provide a better option for patients abroad," Dr Ding says, adding that the US should ideally be the first overseas market for Conmana.
　　Talented People
　　During the interview, Dr Ding mentions several times that he is very proud of the people working at Betta. "Talent is an extremely important asset for us to grow into the company we envision ourselves to be. The biggest challenge for me as a CEO is constantly thinking about how to keep them, and attract more," he says.
　　The key lies in finding the right person and creating an evolving incentive plan.
　　"When people come to us, we tell them honestly that we, as a start-up, may not be able to afford the package provided at multinationals, but we provide a growing career and a promising future. This way, we can find out what they are after," says Dr Ding, adding that many of his staff used to work at multinationals.
　　"Our sales team has grown to 200 people from 50 since 2011, and our senior management team remains stable," Dr Ding says proudly.
　　Unlike other big pharma companies, that tend to hire highly educated talent, Betta has its own hiring strategy. "We have PhD holders with extensive experience abroad for early-stage research, but we also have fresh college graduates working in the lab. Everyone has the right talent for the right position," Dr Ding concludes.