Zhongshan health and medicine to independent research and development move industrial revolution

The 2015-08-05 09:26:51

Source: southern daily

Map in zhongshan new town of professional development, in 2020 the city will form a sales revenue exceeds 500 billion yuan industry, over RMB 100 billion yuan of three industry. Among them, health medicine is 100 billion yuan a piece in the territory.

Map in zhongshan new town of professional development, in 2020 the city will form a sales revenue exceeds 500 billion yuan industry, over RMB 100 billion yuan of three industry. Among them, health medicine is 100 billion yuan a piece in the territory.

Under the background of industrial transformation and upgrading, health and medicine is the emerging strategic industries in the town. It is predicted that with the progress of technology and the deepening of the market battle, China biological medicine research and development and industrialization ability increased significantly, chemical medicine, traditional Chinese medicine, biological medicine drugs of the three pillars of the new pattern has been formed. A period of time in the future, for cancer, heart disease, high blood pressure, diabetes, neurological diseases such as serious illness of a new drug, will enter a large-scale clinical trials, the high-speed development of Chinese bio-pharmaceutical era has come.

As a health major platform for the development of medicine industry, is located in the torch development zone of national science and technology industry base and health as the domestic medicine market change and usher in new opportunities and challenges. Based on the national ministry of science and technology, the provincial people's government and the government jointly established a high starting point, zhongshan city, the base has also had the first according to the international recognition of GLP and GCP, GMP and GSP standard of the construction of the national integrated health industrial park, attracted the world famous enterprises in recent years, however, pharmaceutical, hui ling pharmaceutical, NBTY, etc in oz companies in the United States; At the same time, also able to include kanfen creatures, star's son pharmaceutical industry, pharmaceutical industry, and cultivate the ciic pharmaceutical group and medicine group such as a batch of only three local star enterprise.

However, from the point of scale, output and agglomeration effect, health base from heavyweight "national" there is still a certain space. How the innovation driven development in hot environment policy dividends of radiation, and with the market to obtain a flexible docking vitality, is a professional health medicine industry in the new town, "and more than four with clusters", innovation-driven development under the macro concept should focus on looking for micro proposition.

As the "in search of sun yat-sen and the power of" opening, this report from kanfen ciic pharmaceutical biology, pharmaceutical enterprises of the two bases of the perspective of innovation active function in health and medicine industry. From the two companies to build the innovation platform, to master the core technology, independent research and development to leverage enterprise development, is for companies to get financing, the biggest leverage to a growth of chip. In the same industry, different areas, kanfen wisdom in biological and pharmaceutical use personalized innovation-driven development strategy, to write the current enterprise upgrade common trend: the core technology innovation how to led products and industrial revolution. To some extent, kanfen ciic pharmaceutical biology and narration of innovation-driven development, not only in "a research and development to bring a product" on the expression of more reflected in "a platform to drive a cluster" narrative. More importantly, their choice of independent innovation strategy, are based on economic law and the law of the industrial chain systems engineering, rather than a one-way technology project. So, a new round of growth of the zhongshan health and medicine, is likely to gain new strength in the enterprise microscopic initiative.

Southern daily reporter Li-chuan lo

Founded three years later, sun yat-sen kanfen biological pharmaceutical co., LTD. (hereinafter referred to as the "kanfen biological") is about to finish the second round of the about 80 million yuan.

This regarding kanfen creature is particularly true for the young star enterprise. Seven r&d project at present, the company has entered the stage of development, is expected in 2016 or 2017 successively completed pre-clinical research. Among them, including IL12p40 antibodies for psoriasis and other domestic is in blank wonder drug.

As time precipitation, the first by Dr Four returnees entrepreneurial company of new drug research and development of biomedicine, and also to the market. In tumor immunotherapy antibody research, for example, according to estimates, for kidney cancer, bladder cancer, and patients with ovarian malignant tumors, such as specific in the near future is expected to achieve, in the industry, the research and development is regarded as "the world cancer research in the history of the real revolutionary breakthrough".

Kanfen creature:

To leverage antibody drug r&d innovation revolution

Target is not easy to copy the "core technology"

On March 19, 2012, after a long preparation, zhongshan kanfen biological pharmaceutical co., LTD., was formally established. The company's core members, after all is a senior international pharmaceutical companies to develop the high level of student talent, management experience. Xia Yu kanfen biological President and chief executive, was abbott pharmaceutical companies in the United States, a senior scientist; Vice President and chief scientific officer, li yong, once America's Pfizer's director of research and development; Vice President and chief commercial officer wang zhongming, after is the implementation of the consultant aditya bio-pharmaceutical companies in the United States; Zhang peng, vice President and chief operating officer was scientists abbott pharmaceutical company in the United States.

That year, is listed as one of zhongshan city to introduce one of the "ten key projects" kanfen biotechnology company, its entrepreneurial team, Dr Medical expert team, independent research and development, technology elements such as attracted social attention, be labeled as a "high-tech" "innovative".

Unlike ordinary pharmaceutical companies, Xia Yu and others use their mature research and development capabilities, the company positioning to follow international high-tech enterprise of biological drug development frontier. After founded, kanfen biological quickly determine their own core technology power direction, including quick multidimensional hybridoma generation, 3 d humanized antibody and optimization, fast, efficient and stable cell lines and cultivation, proteins and antibodies, instantaneous efficient expression, found new antibody phage display and affinity maturation and so on.

"The core technology of science and technology content high, not easy to be copied and imitation, in the domestic leading level." Xia Yu introduction, through the core technology, combined with the company has built the antibody drug preclinical technology platform, create a new antibody amino acid has biological activity sequences, achieve new global invention patent, then complete the pilot production.

And its main business model, is the use of the above core technology and public service platform, through to "product customization service" and "new strategic cooperation development" and other two modes for the pharmaceutical enterprises with technology outsourcing services and technical cooperation, short mid-term development for the enterprise to create cash flow.

The practice of the industrialization of the antibody drug

Drug development is a research and development cycle is long, high cost of output form of entrepreneurship. To maintain operations, kanfen biological survival and development of architecture in three support: provide product customization service, open new strategic cooperative development projects and transfer of new drugs and independent development of the listed products.

The so-called product customization service that customers will subcontract to kanfen part in development of new experiment, provides the high quality by kanfen technology outsourcing services, the company of such outsourcing total contract amount has exceeded 80 million yuan. New strategic cooperative development, namely kanfen mainly complete biotech pharmaceutical research front end of the initial findings, laboratory study and pilot, preclinical research, clinical trials and clinical approval and production approval, and drug companies relay, undertake the task the backend production, marketing and other business, according to statistics, more than 49.5 million yuan worth of such contract; Listed new product transfer and independent development mode, including the company through the first project to a certain stage, such as obtaining stable cell lines, etc., approval documents, access to clinical and then transfer to varieties, achieve more value and benefits of the project.

The biggest value chain, in order to occupy the market kanfen will for certain projects independently before the discovery of new drugs, clinical research, clinical research and production. Xia Yu introduces, at present the company already has a lot of single drug resistant product line, the first to realize the industrialization of antibody drug varieties, for IL12p40 antibodies and used in a broad spectrum of cancer treatment in patients with psoriasis PD1 / CTLA4 bispecific antibodies. At the same time, kanfen antibody drug product line includes a dozen for a wide variety of tumors, autoimmune disease such as indications of r&d project, including seven project has entered the stage of development.

"The seven project will be due in 2016 or 2017 successively completed preclinical research, clinical approval." Especially the company of the antibody in tumor immunotherapy was a great breakthrough in nearly two years, have already provided specific for melanoma and lung cancer patients, and will in the near future for kidney cancer, bladder cancer and ovarian cancer, to provide specific malignant tumor patients. According to the assessment, it will be the world cancer research in the history of the real revolutionary breakthrough.

Antibody drug research and development platform for industry innovation ability to ascend

Through technical innovation and capital financing, kanfen plan in the next 3-5 years developed into the largest in south China and even the whole country focused on antibody drug platform to develop innovative technology services and outsourcing service enterprises, in new drug research and development technology outsourcing services in the province more large-scale industrialization.

On the development of enterprises and industries to innovation-driven, kanfen biological antibody drug research and development in the whole process of the platform will also for the domestic and international large pharmaceutical companies, small and medium-sized biotech companies and university research institutes provide innovative technical service platform, to help improve the level of drug discovery industry enterprises, accelerate the process of industrialization. According to the forecast, through the above two kinds of business model, the platform in the next five years accumulative total output value over 100 million yuan can be realized.

From the point of the current development situation, in the next 5 to 6 years, kanfen creatures are expected to be developed 5-6 with independent intellectual property rights, against cancer, immune system disease, cardiovascular disease, diabetes and other clinical drugs, monoclonal antibody and open in collaboration with big inside and outside the province by the drugs for clinical trial and production application, finally the regional and even national level of antibody drug research and development and the localization of bring a whole new level.

In talent education aspect, the company has and sun yat-sen university, jinan university, Peking University and Chinese academy of sciences and other institutions to carry out a full range of production-study-research cooperation. At the same time, kanfen creature is planning to apply for post-doctoral mobile stations, and jinan university and south China university of technology and engineering master's training and authorization center for the training of specialists in the field of antibody of guangdong province and countries, is expected in the next three years, a total of around 100 new high-end biomedical research and development personnel.

Through the entire antibody drug research and development platform and the independent innovation ability, kanfen creatures will stimulate the development of the biological pharmaceutical and biotechnology industry, forming a biological pharmaceutical industry cluster in guangdong province, drive the upstream and downstream industries and the rapid development of outsourcing service industry. This, including gene synthesis, pharmacology and toxicology, GMP production, detection, reagent production and industry facilities, such as clinical trials. The formation and development of the whole industry chain, is expected to break the bottleneck of the industrialization of the antibody drug and the situation of monopoly by foreign pharmaceutical company.

Southern daily reporter Li-chuan lo the correspondent Liang Lijun intern Hu Ling towers

Ciic pharmaceutical:

Traditional Chinese medicine new sparkles between innovation and tradition

This year on July 13, ciic group listed on the Hong Kong stock exchange main board, group executive director Qiao Weilin company operation, performance plan has been collected materials, was surprised to see that the advice to investors without exception is blunt wall-breaking yinpian technology.

After more than ten years of innovation and development of science and technology, located in the base of health ciic pharmaceutical group is from a small pharmaceutical wholesale stores, achieve the core technology with independent intellectual property rights, and annual sales of pharmaceutical group has more than 500 million yuan. Recently, the wall yinpian technology with the independent intellectual property rights, ciic pharmaceutical again drive capital markets, rely on innovation has become the focus of investment market.

Traditional Chinese medicine utilization problems of cracking

"In fact, before 2003, I have been looking at Chinese super fine powder technology, also very bullish on the application of this technology in traditional Chinese medicine (TCM)." Ciic pharmaceutical group deputy general manager and chief engineer, director of the herbalists to kindle, said, "because of the traditional Chinese medicine (TCM) individuals, different parts, people use the traditional method when taking Chinese traditional medicine, active ingredients there are differences. But by putting a lot of the same medicinal materials into powder, also is the effective component uniformity."

After joining ciic in 2003, into the kindle, ciic pharmaceutical group chairman Lai Zhi filling put forward this idea, with its support, established at the beginning only put the next table and a jet mill laboratories, carrying out a research into the medicinal powder.

Take herbs with traditional decoction method, the actual release of active ingredient utilization rate is only 20% - 30%, but by the technology of cell wall, the medicinal materials to make small, large surface area of the powder, can make the active ingredients of the medicinal materials exposed, the water flushed again taking, utilization rate can reach 90%. But this raises another question: powder surface area is big, easy to moisture absorption and oxidation, unstable for storage. Into the kindle has gradually mature scientific research team, led the company to all over the country, found some graining process was achieved by shape fixing agent, starch, also can't meet the requirements of the drug purity. So he began to break the walls of his powder "shape", the original even tried manual grope for the "shape", and then step by step, and the technology to realize with the machine.

Ciic has developed in the end, a special process, without adding all sorts of starch, sugar, under the premise of shape fixing agent, will be broken after powder condenses into larger granular, making the surface area decreased by 60% - 80%. With aluminium film packaging, can hold more than 2 years time.

Build 62 wall-breaking yinpian local standards

Although the wall slices was developed in 2005, when entering the market have met problems - as a new technology, new drugs, domestic didn't wall-breaking yinpian industry standards, so countries also temporarily not give access.

Just as guangdong intends to create "Chinese medicine strong province", ciic will seize the opportunity, immediately with the province put forward to build the wall yinpian industry standards, immediately attracted attention, won the draft with the guangdong institute of drug quality standard.

After acceptance standard and get permission industrialization and ciic again in subsequent years rapidly established and approved the 62 guangdong wall-breaking yinpian place product standards. After realizing industrialization in 2013, the wall yinpian ciic to become the province only Chinese medicine production pilot enterprises, from its first seven varieties wall-breaking yinpian so far more than 20 varieties, market reaction is very good.

Why set up 62 standard, but only more than 20 listed product? According to the kindle explanation, in addition to process can be achieved on the production, in the medicine industry chain must also to have certain guarantees at its source. Different from other particles drug, break the walls of ciic production slices are made from pure herbs, this method make the medicine effective component exposed, but harmful ingredients such as pesticide, aflatoxin will be magnified. Therefore, in the research and development of broken wall slices at the same time, and production control system and the standard of Chinese herbal medicine.

"After the enrichment of heavy metals and pesticide residues in medicinal materials, basic it is difficult to remove, only through a suitable land, water, and management, in collaboration with local farmers to provide a complete set of standards, accomplish beforehand control." Into the kindle said. Therefore, ciic perennial of dispatched a team led by Dr Everywhere, is now in the domestic set up more than 20 Chinese herbal medicine planting bases, resources, planting technology research, from seed to plant control management, guarantee the back the heavy metals, pesticide residues, processing of medicinal materials meet the requirements. After each batch herbs back, even after more than 20 in the laboratory testing process, to control security influential factors to establish indicators.

Independent research and development to drive 40% annual sales growth

Ciic group "independent intellectual property rights has become the core strengths of innovation development, so far, we have more than 30 patents." Into the kindle, starting from the wall yinpian project research, ciic application related national funding has exceeded 15 million yuan. Marketed wall-breaking yinpian, ciic group profit has become the main source, at the same time, market return profit also feedback the broken wall yinpian project research.

Ciic group at present, the research into every year of less than 3% of the enterprise value, in the independent research and development, sales also has had more than 25% growth in recent years, has reached more than 5, 2014, is expected to achieve 10 $2016 sales.

A big health industry is one of the development of China in the next 10 years. After ten years of innovation and development of science and technology, ciic group has formed the core technology with independent intellectual property rights, the wall yinpian technology mainly includes the traditional Chinese medicine, Chinese medicine fingerprint quality control technology and traditional secondary development research techniques and so on. In terms of scientific research strength, the group owns the state administration of traditional Chinese medicine Chinese medicine wall-breaking yinpian technology and application of key laboratory, people club department post-doctoral scientific research workstation, the provincial enterprise technology center of guangdong province, the traditional Chinese medicine (TCM) broken wall powder engineering technology research and development center, and other national, provincial, municipal platform, formed a PhD, master, bachelor, junior college degree, senior, intermediate, junior titles echelon reasonable team.

Southern daily reporter For Chen Suen ga lam correspondent TuLi