Like many multinational peers Menarini too appears to be keenly watching the evolving R&D action in China, as the Asian giant builds excellence in drug discovery, including in new modalities.

Glen Godresse, CEO, Menarini Asia-Pacific observed that things were moving very fast in China from a product development perspective and some data suggests that of the new molecules that were registered in China, around 40% were locally developed.

“For a company like Menarini that is so focused on business development and partnerships, we have to be focused on China as a potential source of innovation,” Godresse declared.

China has been a hotbed of innovation with Citeline’s Pharmaprojects Pharma Annual R&D review 2023 indicating that 24% of industry’s pipeline was under active development in China, with 5,033 active programs (+20%). A Citeline whitepaper on the Asia-Pacific clinical trials landscape had earlier indicated that 38% of industry-sponsored trials and 30% of academic-sponsored trials were initiated in China between 2019-23.

Godresse indicated that Menarini’s current China focus includes identifying target molecules that are aligned to its strategically important therapeutic areas such as cardiovascular, men's health, gastroenterology and dermatology etc.

“We're building partnerships and contacts with local companies who are aligned to the Menarini ethos in China,” he said.

In addition, given that many of the molecules have been developed with the China market in mind, the critical aspect now, he emphasized, is understanding and assessing the regulatory landscape and the pathway to registration for these molecules outside of China, including what the data requirements of local authorities in the region will be.

The CEO referred to a recent China developed oncology product that had just been registered by the Therapeutic Goods Administration (TGA) in Australia, via a partnership with a US based company. Similarly, earlier this year Shanghai Junshi Biosciences Co’s toripalimab, an anti-PD-1 monoclonal antibody, received marketing authorization from the TGA, with Dr Reddy's Laboratories as partner.

“So, we are working to understand how these China developed molecules will be made available in markets outside of China and what the pathway will be. Once we put all these things together, we'll be in a better place to assess these opportunities and their attractiveness and what needs to be done,” he said.

Beyond the China manufactured or developed molecules, Menarini is also keen to work with local partners to bring “our own innovations to the China market where we think a partnership model makes more sense and it can help to ensure broader access to Chinese patients”.

In 2022, Menarini had entered into a license and collaboration agreement granting SciClone the exclusive right to develop and commercialize Vaborem (meropenem＋vaborbactam) in China. A year later Menarini and SciClone sealed an exclusive sub-licensing collaboration to develop and commercialize Orserdu (elacestrant) in China for advanced or metastatic breast cancer.

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