How COVID-19 brought China vaccine play CanSino onto the global stage
CanSino has parlayed its COVID-19 program into a vehicle with which the Chinese vaccine company has entered the world stage, navigating global trial networks and regulators.
Convidecia, a single-shot adenovirus serotype 5 (Ad5) vector vaccine authorized in five countries, is the second authorized vaccine from CanSino Biologics Inc. (HKEX:6185; Shanghai:688185), but the first the company markets outside China. Its other registered product is Ebola vaccine Ad5-EBOV.
SVP of International Business Operation Pierre Morgan told BioCentury one challenge for CanSino during Convidecia’s development program was creating de novo ex-China networks for Phase III trials.
The company established pivotal trial sites in Argentina, Chile, Mexico, Pakistan and Russia by working with international CROs and identifying entities with “local knowledge” including local CROs and investigators.
Regulatory authorities in several countries have reported largely similar efficacy from interim readouts from the multicountry study.
On March 22, CanSino said China’s National Medical Products Administration (NMPA) disclosed efficacies of 90.1% against severe COVID-19 and 65.3% against any symptomatic disease 14 days after vaccination; protection increased slightly starting 28 days after immunization.
Pakistan reported 100% protection from severe disease and 74.8% against any symptomatic COVID-19 — up slightly from figures tweeted in early February by Faisal Sultan, special assistant to Pakistani PM Imran Khan on health.
The Qiming Venture Partners-backed biotech developed the Ebola and COVID vaccines in partnership with the Beijing Institute of Biotechnology, which is part of the Academy of Military Medical Sciences.
International success of the company’s COVID-19 vaccine could be a boon for Chinese vaccine developers across the board, which have been plagued by previous manufacturing and regulatory scandals.
“Everybody knows that you don’t get into a country unless your regulatory dossier is complete, unless it can withstand an audit.”
Morgan, an industry veteran of over three decades, said Convidecia’s development program went smoothly until it came time to begin global Phase III testing, when the biotech had to build out a global clinical trial network.
“If you’re an emerging company like CanSino, and this is the first time you do an international, multicenter, multicountry study, it’s the first time. It’s the beginning of the experience curve, the learning curve, so it takes a bit of more time just to get things up and running,” said Morgan.
Until Phase III, CanSino relied on its experience with its Ebola vaccine and its Ad5 technology to develop Convidecia. From the Ebola program, “We know the process of transfecting, we know the process of growing the virus cells, we know the process of harvesting.”
Morgan added that Convidecia’s shelf-life — so far confirmed to be at least 12 months when refrigerated and two months at room temperature (25° C) — could be inferred from that of the Ebola vaccine, which is at least 24 months refrigerated.
With Phase III sites now up and running, CanSino can streamline global development of its other vaccines by tapping the relationships it has established with CROs and trial investigators outside China.
Morgan’s vaccine track record includes management of new vaccines and launches for products including meningococcus vaccine Menactra, pertussis booster Adacel and flu vaccine Adacel when he as VP of global product marketing at the Sanofi Pasteur vaccines unit of Sanofi (Euronext:SAN; NASDAQ:SNY) in 2009-13.
He also led an Aventis Pasteur team working with WHO and UNICEF on a global strategy to eradicate polio, drove development and implementation strategies for global products and debuted pediatric vaccines in 1998-2003, when he was VP of product marketing and VP of international marketing the unit of Aventis S.A., which merged with Sanofi-Synthelabo S.A. in 2004.
Global success of CanSino’s vaccine could be a turning point for the Chinese vaccine industry, whose reputation suffered from a scandal that drove China to pass its first vaccine law in June 2019. The reforms were implemented in response to NMPA’s discovery that Changchun Changsheng violated manufacturing regulations by falsifying production records for human rabies vaccines. The Changsheng Bio-Technology Co. Ltd. subsidiary’s diphtheria-tetanus-acellular pertussis vaccine also failed to meet the potency standard.
Though Morgan acknowledged that there may still be a stigma on vaccines developed in China and that the scandal is still likely on the minds of global regulators, he thinks the quality control and cheating issues won’t recur. Chinese companies who want to compete outside China “know they’re going to be under extreme scrutiny by the regulatory authorities” and “they have to play the game at the same level as the others — international players — which is clearly the case for CanSino,” he said.
“Everybody knows that you don’t get into a country unless your regulatory dossier is complete, unless it can withstand an audit, unless you can have an inspection of your facility,” he added.
Behind CanSino’s COVID-19 vaccine are a tetravalent meningococcal conjugate vaccine under NMPA review and a diphtheria-tetanus-pertussis vaccine in Phase I testing.