China’s Hisun Files IND For Cholesterol-lowering Drug In U.S.
Hisun, best known for a proposed JV with Pfizer on branded generics, is looking to move up the value chain into R&D. SHANGHAI – One of China’s leading active pharma- latory consulting for the IND preparation (CMC, phar- ceutical ingredient and finished product manufacturers macology/toxicology and clinical development plan/
Zhejiang Hisun Pharmaceutical Co. Ltd. has filed an protocols), U.S. FDA communications including pre-
investigational new drug application with U.S. FDA to IND meeting, IND filing and post-IND filing, and drug
initiate clinical trials for HS-25, an innovative cholester-
development and regulatory consulting on their clinical ol-lowering compound to treat onset of hypercholester- development programs. Frontage will also conduct the olemia and nephrotic hyperlipidemia.
other clinical pharmacology studies for Hisun,” Frontage China General Manager and Senior VP Nick Zhang said Hisun conducted all preclinical research on the product in in an interview with PharmAsia News.
China, partnering with contract research organizations. The preclinical data, including IND-enabling pharma- While multinational companies still struggle to include cology/toxicology studies and CMC data, are also being China in early clinical studies for innovative products, used to file a clinical trial application (CTA) with China’s Chinese companies are positioning themselves to launch State FDA.
simultaneous studies on both sides of the Pacific by part-nering with CROs like Frontage.
HS-25 is a selective inhibitor of intestinal absorption of
cholesterol and related phytosterol, which is the same “There appears to be such a trend,” where Chinese com-
drug class as Merck & Co. Inc.’s cardiovascular block-
panies are now launching parallel studies in China and buster Zetia (ezetimibe), which generated $1.9 billion for the U.S., Zhang said. “Frontage has been providing drug Merck globally. Zetia will lose patent protection in the development, regulatory consulting and U.S.-IND-filing U.S. in 2017.
services to several Chinese pharmaceutical companies for their respective first IND project.” To file the IND in the U.S., Hisun is working with , an
integrated CRO with facilities in both China and the Frontage is currently working on several IND projects for
U.S. Frontage is responsible for HS-25’s IND filing in the Chinese companies planning to file in the U.S., according
U.S., including IND communications with FDA, and will to Zhang, who previously served as a director at Novartis
conduct the Phase I trial and other clinical pharmacology AG,’s research facilities in Shanghai, where he led drug
studies at its U.S. facilities.
product optimization for global and local development projects.
Hisun has filed for patent protection for HS-25 in China and globally via the Patent Cooperation Treaty (PCT). Frontage is trying to differentiate itself from other China CROs by operating facilities on both sides of the Pacific The compound will be the first innovative molecule from that utilize a common platform. In addition to a two- Hisun’s in-house research team to enter the clinic. The year old clinical site in Zhenzhou in Henan province, the company, located in Taizhou Zhejiang on China’s South- company also opened a Phase I oncology site last year in eastern coast, plans to file for CTAs shortly for two addi- Changchun, Jiling province, and plans a third clinical fa- tional compounds in preclinical stages. Altogether, Hisun cility in Nanjing, which will focus on cardiovascular dis- aims to file another five CTAs this year.
“Frontage has been working with Hisun for this IND work including providing drug development and regu- Reprinted by PharmAsia News ( Unauthorized photocopying prohibited.
In the U.S., the CRO operates a Phase I facility in Prince- To Western audiences, Hisun is best known for a $295 ton, New Jersey, which has conducted early-phase studies million proposed joint venture with Pfizer Inc. to de-for a variety of therapeutic compounds including oncol- velop, manufacture and sell off-patent generic prod- ogy, as well bioequivalence studies for ANDA filings with ucts in China and globally. Interestingly, Hisun man-FDA. The company’s headquarters are in Exton, Pennsyl- ufactures several statin APIs, including simvastatin, pravastatin, lovastatin and mevastatin, although Pfizer has not commented about the possibility of the JV Hisun: Shift To Innovation
including atorvastatin (Lipitor) ( For its part, Hisun started up in 1956 as a chemical fac- tory and has been publicly listed in Shanghai since 2000. The company is looking to shift from its origins as an API ). supplier to an innovative pharmaceutical developer.
Hisun is also trying to expand its biologics expertise. In Last year, Hisun invested RMB 202 million ($29.8 million) its pipeline, Hisun has 20 biological products in differ- in R&D, or 9.2% of total revenue, according to a stock ent states of discovery and development. Products include market filing. Although R&D investment is still low com- antibodies, recombinant human albumin, human recom- pared to most innovative MNCs, its level almost doubles binant insulin, fusion proteins and vaccines.
the average R&D investment of 4-5% of total revenue for leading domestic pharma companies, Hisun says.
And its AnBaiNuo, a biosimilar version of Amgen Inc.
and Pfizer’s Enbrel (etanercept) for rheumatoid arthritis,
Leveraging its API business, last year Hisun secured four has completed Phase III trials in China and has an NDA manufacturing transfers from MNCs to move pharma- pending with SFDA. Pfizer reported Enbrel sales outside ceutical finished product manufacturing to China, the U.S. and Canada were $3.67 billion last year. For highly specialized industry insight on the Asian marketplace, visit: PharmAsia 2012 F-D-C Reports, Inc., An Elsevier Company, All Rights Reserved.
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Reprinted by PharmAsia News ( Unauthorized photocopying prohibited.


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