A roundup of some of the biggest recent stories from Chinese pharma, including Moderna’s refusal to divulge its mRNA IP, Advanced MedTech’s acquisition of urology leader WIKKON and Menarini’s AMR deal with SciClone Pharmaceuticals.
Moderna holds onto its vaccine IP and refuses tech transfer in China (Financial Times)
Moderna has turned down China’s request for the core intellectual property behind its breakthrough messenger RNA Covid-19 vaccine, a decision which has led to a collapse in negotiations for its sale in the last remaining major economy without mRNAs vaccines.
Beijing has offered two options to foreign Covid-19 vaccine makers looking to distribute in China. They can either carry out a full technology transfer to a Chinese drugmaker or set up a manufacturing facility in China with a local partner, while maintaining control over the technology. After being urged to accept the first of these options and already having turned down a tech transfer offer in Italy, Moderna has again decided to retain control over its IP. As of yet no mRNA vaccines have been approved for therapeutic purposes in China.
Chinese pharma’s US expansion to face greater regulatory scrutiny (South China Morning Post)
After an executive order from US President Joe Biden, which outlined the industries subject to heightened regulatory scrutiny from the Committee on Foreign Investment in the United States (CFIUS), financial analysts say that Chinese pharmaceutical companies will see their US expansion held back by tougher regulatory scrutiny, particularly in the biotechnology and biomanufacturing sectors.
“We believe transactions involving biotechnology and biomanufacturing will be subject to stringent screening by the CFIUS, as the US is keen to protect its technological leadership and therefore national security,” said Flora Zhu, corporate research director at Fitch Ratings.
In a recent example Asymchem, a pharmaceutical research and manufacturing company based in Tianjin, saw its acquisition of 81.82 percent of Massachusetts-headquartered Snapdragon Chemistry blocked by the CFIUS. In addition, the CFIUS recently delayed the USD 161 million acquisition of the US-listed biotechnology company F-star Therapeutics by Sino Biopharmaceutical.
Almirall USD 507 million deal with Simcere for its IL-2 drug (Press Release)
The Chinese company Simcere has out-licensed ex-China rights to its interleukin 2 mutant fusion protein, SIM0278, to Almirall for USD 15 million with a further USD 492 million in milestone payments and sales-based royalties in view.
The drug is set for a first-in-human study as a potential treatment for various autoimmune diseases.
Advanced MedTech acquires China’s market-leader in urology (BioSpectrum Asia Edition)
Urology heavy hitter Advanced MedTech Holdings (AMTH) is set to acquire a majority interest in WIKKON, the Chinese market leader in urology.
WIKKON, specialized in the development and manufacturing of solutions to treat urological and orthopedic conditions, has the largest installed base of over 6,000 urology treatment devices in China.
Menarini and SciClone sign deal to address AMR in China (BioSpectrum Asia Edition)
Menarini Asia-Pacific Holdings, part of The Menarini Group, and SciClone Pharmaceuticals have signed an exclusive licensing agreement to develop and sell Vaborem, a fixed dose combination of a carbapenem and a novel boronic acid β-lactamase inhibitor of class A and class C serine β-lactamases, in China to combat antimicrobial resistant (AMR) infections.
This agreement intends to expand the options in China for antimicrobial resistant (AMR) infections, specifically carbapenem-resistant Enterobacterales (CRE). Vaborem is already being used to treat patients in the European Union for a number of indications including complicated urinary tract infections (cUTI) and is approved in the US to treat cUTI.
Under the agreement, Menarini will receive a total payment of up to EUR 115 million while SciClone will conduct and fund local clinical development and commercialization of Vaborem. To facilitate access to patients in China, SciClone will conduct local clinical trials and pursue regulatory approvals in China.
Inventiva and Sino Biopharm NASH deal for more than USD 300 million (BioSpectrum Asia Edition)
French firm Inventiva and Chia Tai-Tianqing Pharmaceutical Group Co. (CTTQ), a subsidiary of China-based Sino Biopharm, have signed a licensing agreement for lanifibranor, Inventiva’s compound, for the treatment of non-alcoholic steatohepatitis (NASH).
CTTQ will pay Inventiva USD 12 million upfront and an additional USD 5 million if certain milestones are met in exchange for exclusive rights to develop, import, manufacture, commercialize and market lanifibranor in mainland China, Hong Kong, Macau and Taiwan.
Chinese API manufacturer, Zhejiang Tianyu Pharmaceutical gets further FDA reprimands (Fierce Pharma)
Zhejiang Tianyu Pharmaceutical has been served a second warning from the US FDA after an inspection of its plant in Zhejiang. The regulator’s complaints were linked to impurities in found in one of its drug ingredients. Since similar concerns have been raised in the past, the FDA is urging the company to seek help from an outside consultant to get its manufacturing operations in order.
The FDA also found the company at fault for failing to conduct comprehensive evaluations of its manufacturing process to identify potential impurities and for its negligence in equipment cleaning, which it failed to do often enough for the regulator’s standards.
According to a securities filing to the Shanghai Stock Exchange, Chinese CDMO Jiuzhou Pharmaceutical plans to buy a Sandoz finished drugs plant in Zhongshan for USD 15.1 million and turn the facility into a subsidiary once the deal is closed in early 2023.
Jiuzhou, with a CDMO offering that includes drugs in oncology, diabetes, cardiovascular diseases, antidepressants, antivirals, and central nervous system disorders, is already a contract manufacturer for Novartis, as well as Roche, Gilead Sciences and Daiichi Sankyo.
Sandoz is in the process of spinning off from Novartis.