HONG KONG – Chinese vaccine developer Cansino Biologics Inc. is on its way to becoming the seventh pre-revenue biotech to list in Hong Kong. Expected to debut on the main board of the Hong Kong Stock Exchange (HKEX) on March 28, Cansino aims to raise up to HK$1.26 billion (US$160.5 million).

Cansino is offering about 57.2 million shares globally at a price between HK$21 and HK$22 per share, under the stock code 6185. It plans to use 80 percent of the proceeds to develop and commercialize its core products, 10 percent to advance its preclinical candidates and another 10 percent for working capital.

Prior to the IPO, the vaccine maker has raised about $148.9 million in several financing rounds, including a $65 million investment in April 2017. (See BioWorld Today, April 18, 2017.)

The company has 15 vaccine candidates for 12 disease areas in its pipeline, with three approaching commercialization, six entering clinical trials and another six in preclinical stage. It is best known for developing Ad5-EBOV, the first approved Ebola virus vaccine in China for emergency use and for the national stockpile.

As of 2018, Cansino has recorded losses of $20 million. The proceeds will help market its meningococcal conjugate vaccine (MCV) candidates, MCV-4 and MCV-2, that treat meningococcal meningitis. Cansino plans to seek NDAs for those candidates this year and to market them next year.

In a tower overlooking Hong Kong's harbor, the founders of Cansino sat down with BioWorld to share their visions for developing better vaccines for China and the world.

"We position ourselves as a China-based biotech company with a global vision," Xuefeng Yu, CEO at Cansino, told BioWorld. "We are a dream team – one that has experience abroad and hands-on practice at home.

"We need to walk on two legs. We don't just address the unmet needs in China, but also the world," he added.

Yu said Cansino focuses on developing globally innovative vaccines as well as first-in-class and best-in-class vaccines in China. And the company has a strong pipeline.

MCV-4 is a potential first-in-class vaccine in China, as the country still uses MPSV while others have switched to MCV-4. Vaccination must take place before a child turns 2 to induce immune responses, and Cansino's MCV-4 has proved safe for infants as young as 3 months in phase III trials. The vaccine also shows immunogenicity in children ranging from 3 months to 6 years.

Meanwhile, MCV-2 is a potential best-in-class vaccine in China. In phase III trials, it demonstrated a superior safety profile in children, 6 months to 23 months, compared to other marketed vaccines in China.

"We have a number of carrier proteins, including CRM197, which is produced by our proprietary high-yield bacterial strain and used in our MCV candidates," said Tao Zhu, chief scientific officer at Cansino, explaining to BioWorld what makes the company's core products superior to others.

"We also developed culture media formulations free of animal components," he added.

But what has earned Cansino worldwide publicity is its efforts in developing Ad5-EBOV. It has a superior stability profile because of its freeze-dried dosage form that makes it possible to store it at between 2 degrees C to 8 degrees C for up to a year, while other Ebola virus vaccine candidates require ultra-low temperature storage at below -16 degrees C.

From concept to approval, Cansino only took three years to bring Ad5-EBOV to patients, when the timespan normally takes 12 to 15 years. The company is now in talks with the World Health Organization and other countries to extend the vaccine's reach.

Also notable in Cansino's pipeline is a DTcP vaccine portfolio that targets diphtheria, tetanus and pertussis and covers all age groups. It includes a potential best-in-class DTcP vaccine for infants and a first-in-class DTcP booster vaccine in China, both currently in phase I trials.

It is also studying in the clinic a Tdcp adolescent and adult candidate, which is a potential global best-in-class vaccine; two pneumococcal vaccine candidates that could be globally innovative and best-in-class in China, respectively; and a globally innovative tuberculosis booster vaccine candidate.

Going global

Cansino's strong R&D capability is derived from the founders' extensive experience at multinational drugmakers such as Sanofi Pasteur, Astrazeneca plc and Wyeth (now Pfizer Inc.), where they led vaccines R&D for more than two decades.

The founders now intend to leverage their global experience and vision to spearhead vaccine development in China, especially in the area of quality assurance.

"Our strength lies in our decades-long experience working at the multinational companies, which we can bring to China. Quality by design, for example, is not yet applied in China. We hope to lead the development in this area in the sector," Shoubai Chao, chief operating officer at Cansino, told BioWorld.

"Our experience can help China better align with the world. China has joined the ICH [International Council for Harmonisation], and biotech companies need to comply with international regulations, but they might not have a thorough understanding of them. This is where we stand out, as we have always developed our products in accordance with international standards," he added.

Founders also said their experience could help China formulate regulations for the vaccine industry and introduce new production technologies to the country.

"Quality by design needs to be supported by new production technologies," CSO Zhu said. "We also bring back experiences of other countries where they fail in product design, so we can avoid the same mistakes."

The ultimate goal, according to Chao, is to help Cansino and the whole industry to go global.

Cansino has already forged partnerships with McMaster University and the National Research Council of Canada. It is also in talks with a team from Italy.

To support Cansino's plan to extend its presence worldwide, the founders said listing on HKEX is of strategic significance, as Hong Kong is an international financial center where investors are sophisticated.

"Biotech development has boomed in China. The new listing regime by HKEX came at very right timing, as it serves as a platform to support China's biotech sector," Dongxu Qiu, senior vice president of Cansino, told BioWorld.

Since HKEX officially started to accept IPOs from pre-profit biotechs last April, six biotech companies have been listed. They are Ascletis Pharma Inc (HKG:1672), Beigene Ltd. (HKG:6160), Hua Medicine Ltd. (HKG:2552), Innovent Biologics Inc. (HKG:1801), Cstone Pharmaceuticals Co. Ltd. (HKG:2616) and Shanghai Junshi Biosciences Co. Ltd. (HKG:1877).

Three more are on the waiting list, including Taizhou-based Mabpharm Ltd., U.S./China-based Micurx Pharmaceuticals Inc. and Shanghai Henlius Biotech Inc.

No Comments