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Alphamab determines to power China’s biopharmacy innovation with independent R&D

time:01/25/2018 page views: resource:BioBAY

In October 2017, Alphamab’s PD-L1 antibody KN035 successfully dosed the first patient in Japan, following Phase I clinical trial implemented in the United States and China. China’s first PD-L1 monoclonal antibody has accelerated the pace of Phase I study globally. In November 2017, Alphamab’s KN015, a long acting FSH used in infertility, was awarded a patent in the United States and has entered the Phase I clinical study. When the drug is available in the market, the foreign monopoly will be broken, opening a new chapter of assisted reproductive therapy market of China. In December 2017, LM001, a biosimilar of recombinant human follicle-stimulating hormone injection developed by Alphamab, was approved by China Food and Drug Administration (CFDA) to carry out the clinical test. This drug is produced with advanced, high-efficient and low-cost production process, and will bring enormous social and economic benefits after it is available in the market...

In the past two months, Alphamab Co. Ltd. has reported successive triumphant news and become a focus of the industry. As one of the first bio-pharmaceutical firms of China engaging the biosimilar discovery, Alphamab has significantly promoted the biosimilar development of China with foreign project assignment. As one of the pioneers of biological macromolecule drug development of China, Alphamab has launched multi-center clinical tests internationally from time to time for its innovative drugs. It is one of the first biopharmaceutical firms introduced to Suzhou Industrial Park (SIP). It is not only a partaker and witness of development of the bioengineering and pharmaceutical industry of Suzhou, but also an active player in promoting the international layout. 

“Introducing advanced technological results from abroad to China, and developing ‘affordable’ drugs for the Chinese people” --

Biosimilar production lines cover 80% of foreign golden branded drugs, with more than 70 drugs under development Alphamab was established in 2009 by Dr. Xu Ting, a specially engaged expert under the national 1000 Plan. The core business of the company is to study and industrialize antibody and protein macromolecule drugs. 

In 2009, Dr. Xu Ting may be experiencing the greatest doubts from others in his life. Why did he go back China to start a business for he was living a comfortable life in the Unitied States as a post-doctor of Harvard University and chief research fellow of the world leading biotechnology company, holding a green card and having a happy family?

Dr. Xu understood others’ doubts, but he did not doubt his own decision. “Study abroad is to introduce advanced technological results to China from abroad. My ideal is to develop ‘affordable’ drugs for the Chinese people,” said Dr. Xu. At that time there was a big gap between China and the United States and Europe in biotechnology, but Dr. Xu was confident that the next growth pole of biomedicine was in China. Meanwhile he discovered that China was vigorously encouraging R&D and innovation in the biological macromolecule field. “BioBay boasts very preferential policies for the innovation enterprises. I chose to settle in Suzhou unhesitatingly,” Dr. Xu recalled. 

Alphamab started with discovery of anticoagulants for hemophilia. The company’s Chinese name “Kangning” originally meant “anticoagulation”. In 2013 Alphamab successfully completed the first biosimilar application. Since then the company started innovative drug discovery in the fields of tumor, autoimmunity, infertility and coagulation etc. and entered a rapid development stage. At present, Alphamab’s biosimilar production lines basically cover 80% of the bio-drugs with more than US$1 billion of sales abroad. According to the Report on Biosimilar Development of China in 2015 made by Thomson Reuters, Alphamab ranked first in China by owning 28 biosimilars in the rating of “companies with five biosimilars”. 

Though starting with biosimilars, Alphamab did not rest on generic drugs. It has a strong production line with more than 50 products under research, and abundant independent innovation results. Eight Grade I bio-drugs have completed the early druggability assessment and entered the substantial development process. KN015 has entered the Phase I clinical study, KN035 has obtained permit for the clinical study from the drug administration of China, the United States and Japan. A clinical registration application has been submitted in August 2017 for KN026, a world leading bispecific Ab against ERBB family. KN046 and other new generation antibodies have entered the intensive development stage. It is predicted that applications for domestic and international registration will be submitted simultaneously this year and next year. 

“R&D driven” development path, with equal emphasis on “hardware” and “software” of sustainable R&D capability --

A whole-course R&D platform from molecule design to clinical trial, employees are teammates and shareholders as well

In Dr. Xu’s opinion, a viable pharmaceutical firm must keep technological innovation and advancement all the time. He summarized the company’s development path as “R&D driven” type. In the 10 years since its commencement, Alphamab has totally invested nearly RMB400 million in R&D.

Alphamab constructed a R&D center of more than 6,000m2 in BioBay, and established several biological agent R&D centers with independent intellectual property rights, which can handle the whole process from early screening and engineering of antibody protein drugs, druggability assessment, cell strain construction and small trial, pilot plant test scale-up to clinical trial drug production. “The analyse and quality control platform and pilot plant test scale-up platform serve like ‘two carriages’ of the R&D center,” said Dr. Xu, Alphamab’s analyse and quality control platform can independently complete the comprehensive deep characterization of biological macromolecule drugs; the cGMP-compliant pilot plant test workshop consists of a concentrate workshop with four 250L and two 1000L mammalian cell productions lines, and a 6000bottle/h sterile preparation filling workshop, meeting requirements on process scale-up, and consequently laying a foundation for stable industrialization of developed products.

While basing on independent R&D, Alphamab has attached great importance to coordinated R&D with others. It has cooperated with University of Chicago, Harvard University, Chinese Academy of Sciences and other famous universities and research institutions to foster talent and improve its R&D capability. For example, the firm has established the postgraduate and post-doctoral workstations of Jiangsu Province, and joined hands with Southeast University to establish the technological center and establish technological platform with the US-based Thermo.

If the platform construction is the “hardware” supporting R&D of Alphamab, the professional team of the company is its “software”. 

“Alphamab offers us a sense of home-like belonging. We share the common sense of mission, that is to become the best biopharmaceutical firm of China,” said Dr. Guo Kangping, who is responsible for R&D of protein purification and one of the first employees of Alphamab.

According to Dr. Guo, she was taught by Dr. Xu personally. “I was a new graduate at that time. Dr. Xu held a regular meeting every week at the company to introduce the latest industrial trend and literature of biochemistry,” Guo recalled, “Listening to Dr. Xu’s introduction was like reading fascinating novels, as if returning to the university classroom.” Today Dr. Guo has become a R&D backbone of the company and helped Alphamab establish an advanced and mature macromolecule drug purification platform, which reaches to the world leading level in terms of the purification indicators. 

The core of the team building is to establish a highly recognized corporate culture. Dr. Xu is not a pedant. Alphamab is one of the several companies in SIP exercising all-employee share holding.

Today Alphamab has more than 110 employees, including more than 10 doctorate holders, more than 40 masters and more than 50 university graduates. To meet needs of the international businesses, Alphamab has established a world leading consultant team consisting of senior scientists, former FDA review experts, senior technology and business personnel and cGMP experts etc. 

Improving accessibility of China’s biological macromolecule drugs is an important way for Alphamab to participate in China’s bio-drug industrialization --

Exporting more than 30 patented technologies to large-scale and medium pharmaceutical firms from home and abroad, building an industrialization base with annual output value of RMB15 billion after being put into production.

Alphamab has actively participated in China’s biological macromolecule drug industrialization by means of project assignment and technological export while improving its own R&D capability to promote accessibility of biological mocromolecule drugs. For years the company has transferred more than 30 technologies such as Avastin and Erbitux to Innovent Biologics, CP Guojian Pharm, Chiatai Tianqing, Qilu Pharmaceutical, Livzon Pharmaceutical Group Inc. and Russia-based R-Pharm and other pharmaceutical firms. In this process, Alphamab has attached great importance to intellectual property. So far the company and its subsidiaries have applied for nearly 50 patents, and be awarded many invention and use patents, and was designated as the high-value patent fostering demonstration project of SIP. 

Alphamab has rewritten its “transcript” from time to time in recent years and was rated as the provincial high-tech SME and national high-tech enterprise, among others. Moreover, with gradual implementation of clinical tests in Europe, United States, Japan, Australia and other countries, Alphamab has embarked on a fast lane of internationalization. More and more foreign pharmaceutical firms got to know the reputation of Alphamab and came to Suzhou to seek for cooperation with the firm.

In October 2017, Alphamab Jiangsu Industrialization Base,which has a total investment of RMB2 billion, was launched in SIP. It aims to industrialize the products under research in the near future to meet clinical needs and benefit the society. The factory will be built in line with the cGMP standards to meet different supervision requirements of China, the United States and EU as well. It is predicted to be completed in 2019. After being put into production, the factory can produce 15 million bottles of biological preparation annually, with annual output value of RMB15 billion. 

“Only by accelerating industrialization can our innovative results be utilized. We expect to build Alphamab into a leading innovative, comprehensive and internationalized large-scale biological pharmaceutical firm with world-class influence that provides domestic patients with accessible world leading advanced therapies,” said Dr. Xu.