STAT China: A debut for CanSino Biologics and Cellular BioMed’s controversy

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Hello and welcome back to STAT China. In this edition, Covid-19 vaccine updates, a privatization proposal draws a backlash, and the CEO of a newly formed biotech startup joins us on STAT Newsmaker.

CanSino Biologics debuts on Shanghai stock exchange

Last Thursday, CanSino Biologics started trading its shares on the Shanghai stock exchange’s STAR Market, China’s version of Nasdaq, becoming the first vaccine maker to dually list in Hong Kong and in mainland China.

The company’s stock rose as much as 127% in its first day of trading, netting almost $750 million in its secondary offering of 24.8 million shares, making it the second most expensive IPO on the mainland.

The funds will be used to support vaccine R&D and the construction of its manufacturing facility, a cold-chain logistics system and an information system, CanSino said.

The Tianjin-based drug manufacturer was China’s forerunner in the race to develop a Covid-19 vaccine but struggled to find an oversea partner to test its vaccine candidate for the final stages of clinical trials. It recently struck a deal with Saudi Arabia to run Phase 3 trials for the vaccine there as soon as possible.

Cellular BioMed’s bid to privatize draws heat from shareholder rights groups

A Maryland-headquartered Cellular Biomedicine Group, which conducts immuno-oncology and stem cell clinical trials in China, is being investigated by a number of shareholders rights law firms for potential securities law violations after the company agreed to be acquired by a newly formed entity backed by a consortium of investors, private equity funds, and certain members of the CBMG’s senior management, including the company’s CEO, Tony Liu.

The completion of the merger will result in the Chinese clinical-stage drug developer becoming privatized as a subsidiary of the new parent company.

Under the terms of the agreement, shareholders will receive $19.75 for each share of common stock, which represents a premium of approximately 31% over the 30 trading-day average price of CBMG’s stock as of Aug. 11, and 12% over its closing stock price on Nov. 8, 2019, the last trading day prior to the public announcement of the consortium’s initial proposal.

The shareholders’ legal representatives are investigating whether CBMG’s board members breached their fiduciary duties or violated federal securities laws in agreeing to the merger deal, and whether its board of directors oversaw an unfair process and is inadequately compensating its shareholders at the current proposed stock price.

CBMG, listed on Nasdaq, maintains its primary R&D and manufacturing facilities in China.

Sinovac’s Covid-19 vaccine starts late stage trial in Indonesia

Beijing-based vaccine maker Sinovac Biotech has started Phase 3 trials for its Covid-19 vaccine candidate in Indonesia, Reuters reported.

The company is developing its candidate, called CoronaVac, with state-owned drug manufacturer Bio Farma and plans to test the vaccine’s effectiveness in about 1,620 patients in the country. The trial is expected to last six months and has recruited up to 1,215 subjects so far. Indonesia joins a growing list of countries that have granted permission for Covid-19 vaccine makers to test their vaccine candidates. Last month, Brazil and Bangladesh gave Sinovac the greenlight to run late-stage trials for CoronaVac.

The Chinese vaccine developer also released data from the vaccine’s Phase 2 trial last week, showing the vaccine appeared safe and elicited immune response in subjects.

Separately, state-owned vaccine rival Sinopharm published an interim analysis of its Phase 1 and 2 trial data for its vaccine candidate in JAMA. Researchers said patients who received the vaccine had a low rate of adverse reactions and demonstrated immunogenicity.

The company launched the vaccine’s Phase 3 trial in the United Arab Emirates last month.

STAT Newsmaker: LianBio’s Bing Li

This is part of an occasional series of brief Q&As with pharma newsmakers in China. This week we talked with Bing Li, CEO of the newly formed LianBio, which is aiming to accelerate access to innovative medicines for patients in China and other Asian markets. This transcript has been edited for length and clarity.

What’s the inception story behind LianBio and why did you choose to join this new venture?
The initial idea was developed by Perceptive Advisors, as part of the firm’s ambition to expand its investment coverage to China and major Asia regions. When I was introduced to the LianBio business model, I was convinced that it was highly differentiated from other China-focused in-licensing biotech players, and can potentially be a very powerful platform to bring paradigm-shifting biotech innovation to China and other Asia regions.

What is the meaning of LianBio and why did you choose this name and logo for the company?
The Chinese character for “Lian” translates to join. Through strategic partnerships and our own talented teams in China and the U.S., we seek to unlock the value of our pipeline by providing access to China’s innovative pharma market, enabling China to be part of global therapeutic development efforts and bringing better medicines to patients.

Can you tell us about your pipeline and your China strategy for these programs in the Chinese market?
We’re focused on sourcing the world’s leading precision-based therapeutics and transformative mechanisms to effect broad impact on conditions of unmet medical need. We’ve already forged a series of strategic partnership, licensing and development agreements that position us to target local Asian markets with promising late-stage assets developed by industry pioneers. These fall under two broad categories:

LianBio’s cardiorenal subsidiary is anchored by MyoKardia’s mavacamten, a first-in-class small molecule therapeutic that reversibly binds to myosin to directly target the excess contractility and impaired relaxation underlying hypertrophic cardiomyopathy, or HCM. Results from its Phase 3 EXPLORER-HCM clinical trial showed statistically significant, clinically meaningful improvements in symptoms and cardiovascular function. MyoKardia plans to file for regulatory approval of mavacamten in the U.S. in the first quarter of 2021 and is also pursuing the development of mavacamten for the treatment of non-obstructive HCM patients and select populations of heart failure with preserved ejection fraction.

LianBio’s oncology subsidiary is anchored by infigratinib, a first-in-class, selective fibroblast growth factor receptor (FGFR) inhibitor from QED Therapeutics, an affiliate of BridgeBio Pharma, currently in Phase 3 development for cholangiocarcinoma and urothelial carcinoma, among other FGFR-driven diseases. LianBio is pursuing the study of infigratinib in first-line cholangiocarcinoma in mainland China as part of QED’s PROOF global Phase 3 study and further plans to initiate a Phase 2a study of infigratinib in gastric cancer and other FGFR-driven tumors. LianBio has also licensed in BBP-398 from Navire Pharma, a novel SHP2 inhibitor focused on treating drug resistant tumors and other hard-to-treat cancers. LianBio will initially be studying BBP-398 in combination with various agents in solid tumors such as NSCLC, colorectal and pancreatic cancer, in mainland China and other major Asian markets.

Many Chinese biotechs have been successful at helping their Western partners develop and commercialize their assets in China. What is LianBio’s competitive advantage?

LianBio’s unique mining effort targeting innovative international assets and our China-centric execution platform enables our partners to access China and other major Asian markets to unlock value. Unlike any of its competitors, LianBio differentiates itself in the following ways:

1. Its exclusive relationship with Perceptive Advisors that provides expanded opportunities to over 150 public portfolio companies, 80+ private portfolio companies, and more than 20 years’ experience in health care.
2. Strategic partnerships and in-licensing agreements with life sciences companies who have deep experience selecting, developing and commercializing assets for clinical success.
3. Ability to attract top-tier strategic and financial partners to expand its platform capabilities and industry influence.

While China and the U.S. relations have declined, standard licensing and partnering relationships in the biotech sector have not been impacted. Are you concerned that ongoing tensions would eventually affect biotech partnerships and collaborations between the two countries?

Our teams have decades of experience leading and transacting successful pharmaceutical collaborations in China and major Asian markets. Our nuanced understanding of these dynamic markets and our teams’ recognized leadership in the industry equips us to navigate changing market conditions. We believe the fundamental need for good medicines is a global issue.

What should we look forward to from LianBio in the next five years?
LianBio is planning to further expand our initial success by licensing an additional 10-15 assets and establishing our portfolio in two to three therapeutic verticals beyond oncology and cardiorenal and forming additional strategic partnership with leading global biotech companies in those therapeutic areas. Secondly, we plan to expand our solid development and commercial capabilities around those therapeutic verticals and starting commercial launches of some leading assets after gaining regulatory approvals.