Ibalizumab (tmx-355), a McAb for AIDS treatment produced by Wuxi apptec for Zhongyu new drug, was approved by FDA

Ibalizumab is a human monoclonal antibody drug developed by Zhongyu new medicine to treat HIV / AIDS infection It is an innovative AIDS therapy called "virus invasion inhibitor" Wuxi biopharmaceutical R & D and production base of Wuxi Pharmaceutical Co., Ltd is the only biopharmaceutical production workshop in China that meets the cGMP standards of the United States, the European Union and China at the same time and adopts the most advanced production technology and equipment in the world The cell culture plant that produces ibalizumab stock solution has just won the "2014 cGMP workshop special award" issued by ISPE The cGMP preparation factory for producing ibalizumab sterile biological products has recently been completed, which is located in the same park as the cell culture factory The preparation line adopts the international advanced automatic small volume aseptic filling system, which can produce 2-50ml liquid and freeze-dried bottle products, and flexibly meet the production needs of global clinical trials and product marketing "We congratulate Zhongyu new drug ibalizumab for this significant progress, which has taken a solid step towards the final market." Dr Li Ge, chairman and CEO of Wuxi apptec, said "Wuxi apptec is committed to providing customers with all-round solutions through the company's integrated biomedical discovery, development, manufacturing and testing service platform, so as to help their innovative biopharmaceutical products reach the global and Chinese market as soon as possible." Dr Zhang nianyuan, chief executive officer of Zhongyu new drug, said, "Zhongyu new drug is very satisfied with the speed and implementation of the cooperation project with Wuxi apptec ibalizumab We very much look forward to the next stage of cooperation between the two sides, and finally promote the successful approval of this important drug to enter the market and serve the vast number of patients " About Zhongyu new drug, Zhongyu new drug (English: taimed biological, abbreviated as TMB), formerly known as Yuchang biotechnology, Taiwan biotechnology pharmaceutical company, founded in 1997 by Chen liangbo, Yang Yumin and Cai Yingwen, with he Dayi, academician of the Central Research Institute, as the company's consultant, to produce AIDS drug tmb-355 Cai Yingwen was the first chairman of the company, so he was involved in the Yuchang case About ibalizumab (tmx-355) in 1997, tanox company obtained the authorization of "tmb-355" (later renamed "tnx-355") from Biogen company In 2000, the first clinical trial was passed From 2000 to 2004, Tang Nanshan, executive director of tanox company, went back to Taiwan many times to find funds, but did not get the support of the government In 2004, tnx-355 passed the second phase of clinical practice In October 2005, the Taiwan government planned to promote the biotechnology industry and invited Tang Nanshan back to China Tang Nanshan and Gao Yuren, chairman of Ouhua venture capital, plan to set up Nanhua biotechnology company and protein factory in Taiwan to produce tnx-355 Tang asked the Taiwan government for 240 million yuan, and the Executive Yuan invited he Dayi, academician of the Central Research Institute, to assist in the evaluation He Dayi and other consultants think that tnx-355's market scale is limited, the establishment of a large protein factory will lead to overcapacity, which is not cost-effective, and it is unable to obtain the patent of the drug itself for further research and development, which is recommended to be rejected As a result, the Executive Yuan vetoed the investment plan, and Tang Nanshan could not find other sources of funds, which failed In 2006, Weng Qihui became president of the Chinese Academy of Sciences He put forward the idea of letting Taiwan's biotechnology industry catch up with the world After exchanging views with the elders in the field of biotechnology, it is believed that a furniture index company should be established, which should be supported by the state investment based on the TSMC model, in order to establish the industrial chain of biotechnology At this time, Genentech, the US company, is going to buy tanox They think the R & D cost of tnx-355, an AIDS drug, is too high, so they decide to sell it After evaluation, he Dayi, Chen liangbo and Yang Yumin, President of global technology operation of Roche Pharmaceutical Co., Ltd., believed that this was a good opportunity to obtain tnx-355 patent authorization In January 2007, they planned to set up a new company, named "taimed", hoping to obtain authorization from Genentech Corporation of the United States to develop and produce tnx-355 AIDS reagent in Taiwan Chen Jianren, chairman of the national science and Technology Commission, and he Meiyue, chairman of the economic and Construction Commission, proposed a plan to Su Zhenchang, then Taiwan's executive director, hoping to invest in the "National Development Fund" to fund its establishment Cai Yingwen, now vice president of the Executive Yuan, once coordinated the economic construction commission and the Ministry of economy to assist in the establishment of Yuchang biotechnology He also persuaded Wang Jinping, President of the Legislative Yuan, to lead the way in proposing new biotechnology regulations and completing legislation to supplement the sources of law In March 2007, in order to raise funds, the Executive Yuan held a public briefing to Taiwan's venture capitalists, which caused gene tech company to be unhappy, believing that Taiwan violated the agreement and leaked the progress of negotiations At the same time, another American company also hopes to win the patent of Genentech and offer a high price The original shareholder of taimed group thought that the authorization fund was too high and suspended the negotiation On May 21, 2007, Cai Yingwen retired as vice president of the Executive Yuan and returned to the people In August 2007, the merger of Genentech and tanox was completed Yang Yumin thought it was a good opportunity to fight for the patent right negotiation He reconvened the team and reopened the negotiation Because of the high cost of R & D investment in the biotechnology industry, it is difficult to raise funds Chen liangbo, Weng Qihui, President of the Chinese Academy of Sciences, Li Yuanzhe and others invited Cai Ying, who had just retired as the vice president of the Executive Yuan, to be the chairman of the company, responsible for integrating investors and negotiating international authorization I hope that with her reputation, contacts and international negotiation ability, we can successfully complete the fundraising and authorization negotiation Cai Ying Ying promised to assist and become the first chairman of Yuchang biotechnology without pay In July of the same year, with the efforts of Tsai ing Wen, we completed the negotiation with Genentech company, and obtained the exclusive authorization at a price of 100 million yuan to develop new drugs in Taiwan But the original investors closed at this time, only uni President International and Shanghai smart venture capital (yongfengyu group) are willing to continue to invest Cai Ying established taimed Inc in Taiwan on September 3 with his family funds He invested 60 million yuan to Yuchang biotechnology to fill the gap On September 4, Yuchang biotechnology was officially established On September 14, an exclusive authorization agreement was signed with Genentech Since then, Yuchang has been authorized by Genetech to develop new HIV drugs and clinical trials [3] [4] Taimed Inc and Yuchang biotechnology are the parent and subsidiary companies Taimed is in charge of holding, looking for investment opportunities and funds, and Yuchang biotechnology is in charge of research and development and production of new drugs In October, Yuchang biotech failed to raise funds, and Caiying family invested 72 million yuan to Taimao biotech venture capital again In March 2008, after the presidential election, the Kuomintang won the election Because of the succession of political power, the funds promised by the National Development Fund were not in place The 30 million US dollars originally promised, including the 12 million US dollars approved by the development fund, were not invested in Yuchang Other private funds, including unified international and other funds, are also afraid to invest due to political pressure Cai Yingwen persuades Yin Yanliang, chairman of Runtai group, to invest US $10 million, and Yuchang biotechnology capital has only reached US $30 million, barely meeting the minimum capital requirements in the power of attorney agreement with Genentech, so that the company can continue to operate In May of the same year, Tsai ing Wen became chairman of the Democratic Progressive Party (DPP) and asked to resign from Chairman Yuchang biotechnology In order to reduce the political color of the company, the family also sold the equity of TSMC to Yin Yanliang, the main shareholder, with a profit of 10 million yuan, and completely withdrew from the business Yin Yanliang, Dong Zuo of Runtai, invited Lu Kongming to invest RMB 118 million to become a new shareholder of Taiwan Mao for the reason that he was not familiar with the biotechnology industry After Taimao changed its name to "he Shengji investment" company, Runtai, taini and Zhongtian shareholders cooperated in the operation right, and Lu Kongming took over the new chairman Among the 30 million US dollars of cash capital of Yuchang, the development fund accounts for 8 million US dollars, and Taiwan Mao accounts for 4 million US dollars In addition, there are Runtai, yongfengyu and unified enterprises [5] On April 28, 2009, Yuchang biotechnology changed its name to Zhongyu new drug In 2010, Zhongyu new drug increased its capital again, and the development fund decided to invest about 4.3 million US dollars again, together with the first 12 million US dollars invested, to obtain about 20% equity of the company In the same year, through the second phase clinical trial of intravenous injection by the food and Drug Administration of the United States, the bill and Melinda Gates Foundation obtained phased subsidies totaling about NT $100 million to jointly develop the vaccine against AIDS It has also signed a contract with the National Institutes of health of the United States to cooperate with the second phase of subcutaneous injection, and is negotiating cooperation and authorization with international pharmaceutical companies Thanks to the recognition of R & D achievements, the company was successfully launched On April 22, 2014, Zhongyu new drug announced that the food and Drug Administration (FDA) has approved its first batch of ibalizumab (tmb-355) The company reports that this is the first FDA approval for a sterile biologic product manufactured in China for U.S clinical trials Ibalizumab is a mo noclonal antibody and a viral entry inhibitor used in the treatment of HIV/AIDS infection TaiMed Biologics is developing the drug Dr James Chang, CEO of TaiMed Biologics said, "TaiMed is pleased with the speed and excellent execution of this project to ensure the success of this im portant drug We look forward to the next phase of collaboration with WuXi to successfully bring the drug to marketing approval.” TaiMed’s Ibalizumab Ibalizumab (TMB-355)
is different from other viral-entry inhibitors because it binds to the CD4 molecule and interferes with virus penetration into the cell TMB-355 was the first virus entry blocker, catching the attention of researchers in 2003 and earning FDA Fast Track status A Phase II trial in 2006 showed a ten-time reduction in viral load and a clean safety profile A Phase IIb trial was co nsidered successful and TaiMed is currently developing a subcutaneous injection delivery system TaiMed is also developing TMB-607, an HIV-1 protease inhibitor, first developed by Ambrilia Biopharma TaiMed licensed TMB-607 in 2011 TMB-571 is a small molecule inhibitor of influenza virus neuraminidase licensed from Academia Sinica in 2008 WuXi's Manufacturing Facility WuXi manufactured Ibalizumab for TaiMed at its cell culture manufacturing facility in Wuxi city, at its newly completed manufacturing suite The company intends to provide manufacturing to global partners The FDA approval of the Ibalizumab batch positions the company for worldwide acceptance Previously in April of 2014, the company announced in a
press release
that the FDA had completed a general GMP inspection WuXi believes that the successful inspection was an achievement for the company because clients would value the regulatory approvals and would trust WuXi to supply drugs co nsistently and gain expedited approval The FDA also inspected clinical trial materials, packaging, and labeling facilities and found WuXi to be in compliance