SHANGHAI – KBP Biosciences (China) Inc. is the brainchild of Zhenhua Huang, a Chinese serial entrepreneur that first found success with his earlier effort, Xuanzhu Pharma. Huang is a rare breed of biotech founder, China-born and educated, he has an international vision for KBP building on the lessons learned from more than a decade of doing business in China.

Founded in 2010, KBP China is held by KBP Singapore which is in turn held by Orion TC Holdings Ltd. The company has facilities in Singapore, Shandong province, and Princeton, N.J.

Huang has invested $36 million in KBP. A significant personal investment by a founder, made possible when Sihuan Pharma Group took a 60 percent stake in Xuanzhu in 2008 and then became full owners in 2012. "I made a large investment in Xuanzhu, and later sold some projects to earn funding for KBP," Huang told BioWorld Today.

Xuanzhu continues to successfully develop what Huang refers to as "Chinese-style new drugs" – drugs that are unlikely to qualify as new drug in other markets but were considered as such under China's drug classification system.

Huang has spent most of his career in China and does not consider himself part of the returnee-scientist crowd. He was educated at Shenyang Pharmaceutical University with an EMBA from Peking University. Nonetheless, he is betting big on his international strategy to stay ahead of the pack and conducts clinical trials outside of China first.

To date, KBP has six candidates under development with two in the clinic in the U.S., covering inflammatory and autoimmune diseases, major organ degeneration and damage, and drug resistant anti-bacterial infections. All self-discovered assets, KBP takes an integrated approach and has three main research groups.

The major organ research group focuses on disease progression in the lung, heart and kidney assessing a drug's active mechanism in both in vitro and in vivo models. An antimicrobial group leverages a microbial bank of 20,000 clinically isolated strains including anaerobic bacteria and fungi to evaluate drug candidates. Lastly, the immunology group conducts research on the roles of T- and B cells in rheumatoid arthritis, hyperuricemia and idiopathic pulmonary fibrosis.

THE 'ME-ONLY' MODEL

Huang's unique strategy kicks in when deciding what candidates to prioritize for development, a model he has coined "me-only." It is his unique take on first in class and an attempt by Huang to rise above China's drug classification system that has defined innovation differently than the U.S. and European authorities (although that is under reform) and a China market crowded with me-too products.

To become "me-only," a drug has to fit what he has coined the "three-no's and one-yes" criteria (or 3N/1Y): no similar drug ahead in development, no existing drug for the same clinical need, not easily imitated due to technical difficulty and with good curative effect.

"Our me-only drugs will have little to no competition from launched or pipeline drugs. With our me-only model we aim to work in areas where there are no good alternatives, whether the same target or other targets" said Huang. "Chinese pharmaceutical companies face the problem that they are often small and are unable to beat the competition from large foreign companies. So an open field is the best for us to play in," he added.

An example Huang gives for a "me-only" drug is Tecfidera (dimethyl fumarate), primarily a preservative, it was found effective in relapsing forms of multiple sclerosis. Developed by Biogen Idec Inc., Tecfidera is still not available in China despite more than 10 Chinese companies trying to make generic versions.

ATTRACTING THE BEST FROM BEYOND CHINA

To implement his demanding "me-only" model Huang said it requires the best experts in the world.

"To compete on the global stage, Chinese companies must focus on solving real medical problems. Only with such a vision can you attract world-class experts to join your efforts. But few Chinese companies have been able to do that," said Huang. "Through continuous efforts in the past few years, we have built a top-notch team including researchers and clinicians to find effective medication."

KBP-5074, a nonsteroidal MR-specific antagonist for kidney and heart in clinical trials in the U.S., has three international experts on the team: Bertram Pitt, a heart expert; George Bakris, a kidney doctor; and John McMurray, a heart failure physician.

Indicated for cardiorenal syndrome (CRS), with a patient population of 5.3 million in the U.S., the KBP-5074 team is tackling a long intractable problem: increased blood potassium levels when going after an MRA target. According to the company, KBP-5074 has already completed phase IIa studies with no concerning adverse events so far.

KEEPING BLOOD POTASSIUM DOWN

"So far, we've conducted testing on animals, healthy volunteers and patients with chronic kidney disease (CKD). The drug (KBP-5074) showed promising efficacy and safety profiles. KBP-5074 could become the drug of choice for CKD, heart failure and a number of related morbidities. No other drug has done so." said Huang.

According to Huang, in the U.S. 10.8 percent of all adults have CKD and there are 7 million heart failure patients. Spironolactone and eplerenone are the standard treatments for these ailments. However, their uses are very limited due to severe side effects. If all goes according to plan, KBP-5074 will enter a market with tens of millions patients who are desperately in need of effective treatment.

Also in the clinic is KBP-7072, a broad-spectrum oral antibiotic; it is a next-generation tetracycline undergoing phase II trials. KBP-7072 is effective on multiple resistant strains in vitro (including MRSA, MRSE, PRSP, VRE and anaerobic strains) for community acquired pneumonia (CAP), a seasonal disease occurring in winter. It also shows strong antibacterial activity against highly prevalent Acinetobacter baumannii which has a significant mortality rate.

KBP is targeting several indications for KBP-7072: multidrug-resistant bacterial infections such as CAP as well as diabetic foot infection, complicated intra-abdominal infections and complicated urinary tract infections.

KBP has a total of four other candidates in its pipeline: Another organ protection drug, KBP-7018 is for fibrosis while a second antibiotic candidate, KBP-7909, is for gram-negative bacteria. They also have two anti-inflammatory candidates: KBP-7026 for asthma and COPD and KBP-7536 for rheumatoid arthritis.