China healthcare and life sciences news. Top stories include the NMPA approvals of CanSino’s inhaled COVID-19 vaccine and AstraZeneca’s CKD treatment, HitGen/Unison’s anti-infectives deal and the funding secured by cell therapy biotech Neukio Biotherapeutics.
Switzerland-based Neovii Pharmaceuticals and Shanghai’s Fosun Pharmaceuticals have made an exclusive agreement for Fosun to develop and commercialize Neovii’s Grafalon (rabbit anti-human T-lymphocyte globulin, ATLG) on China’s mainland, Hong Kong SAR, Macau SAR and Taiwan.
Under the Agreement Neovii will receive regulatory and commercial sales milestones as well as proceeds from supplying Grafalon to Fosun. Grafalon has already been approved for marketing and included in China’s National Reimbursement Drug List.
CanSino inhaled COVID-19 vaccine approved as booster in China (BioSpectum Asia)
The National Medical Products Administration of China (NMPA) has granted CanSino Biologics approval for its recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for inhalation (Convidecia Air) as a booster dose. Convidecia Air uses the same adenovirus vector technological platform as the intramuscular version, providing a non-invasive needle-free booster option.
CanSinoBIO received the approval of its clinical trial application for Convidecia Air in March 2021 after studies showed that Convidecia Air can induce strong humoral, cellular and mucosal immunity to achieve triple protection and effectively contain the infection and spread of the virus.
AstraZeneca’s Forxiga for CKD approved in China (BioSpectum Asia)
AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved by China’s National Medical Products Administration (NMPA). Forxiga reduces the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease (ESKD), cardiovascular (CV) death and hospitalisation for heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression with and without type-2 diabetes (T2D).
Forxiga (known as Farxiga in the US) has been approved in 100 countries including the US, the European Union and Japan for the treatment of CKD in adults with and without T2D. CKD a serious condition affecting 850 million people worldwide, is defined by decreased kidney function and is often associated with an increased risk of heart disease or stroke.
HitGen and Unison Medicines partner to develop anti-infectives (BioSpectum Asia)
Fully owned subsidiary of China’s HitGen, Vernalis Research, and the US-based company, Unison Medicines, have announced a research collaboration on an undisclosed yet challenging bacterial target.
Under the agreement, Vernalis will design small molecules against the target, long considered untreatable, while Unison will finance these activities. Should the compounds coming out of the agreement progress, Vernalis will be entitled to receive downstream milestones and royalties. Vernalis has also invested in Unison’s first round of financing.
Doug Witt, Founder and Chief Executive Officer of Unison, said that the investment demonstrates “the opportunity we see in tackling the Anti-Microbial Resistance problem with highly innovative approaches.”
Shanghai-based cell therapy biotech, Neukio Biotherapeutics, has secured USD 50 million in Series A funds to back its CAR-NK therapies with support from Lilly Asia Ventures, Sherpa Healthcare Partners and IDG Capital
The biotech, which was set up last year, aims to make allogenic cell therapies via the iPSC-CAR-NK axis: The company’s CEO and chairman, Richard Liqun Wang, was previously chief executive of the Fosun and Kite joint venture that landed a first CAR-T cell therapy approval in China last year.
Private equity firms Fountainvest Capital Partners, TPG and Warburg Pincus are among final-round bidders for Carlyle Group’s stake in AmbioPharm, makers of peptide active pharmaceutical ingredients (APIs) with manufacturing facilities in Shanghai. AmbioPharm also has a pipeline of pre-clinical and clinical programmes
Carlyle is targeting a valuation of USD 1 billion for Ambio and expects a deal to be reached by the end of September at the earliest.