Editors' (re)View: Lilly ventures into the dark genome; China's crackdown on pharma

From trash to treasure

In 2003, the Human Genome Project produced a map of the human genome, showing over 20,000 protein coding genes (similar to most mammals). One of the surprising discoveries was that a large portion of the human genome was made up of non-coding DNA — in fact, the protein coding genes accounted for just 2% of human DNA.

This non-coding DNA had previously been written off as junk, but how could it be given the findings? As science has progressed, many believe that this 'dark genome' is not only biologically relevant but actually the key to understanding how cells operate.

One such company is Haya Therapeutics. Founded in 2019, Haya emerged with a $20 milllion seed round in 2021. The company focuses on part of this dark geneome known as long noncoding RNAs (lncRNAs). LncRNAs regulate disease-associated gene pathways and proteins in response to the environment, triggering a disease-associated cell state.

Haya's proprietary regulatory genome discovery platform enables the identification of tissue-, disease- and cell-specific llncRNA targets and the development of RNA-targeting therapies, with potentially better efficacy and less toxicity than current treatments, to reprogram disease-driving cell states. 

The company believes its platform can be applied to any cell state and any tissue — which means it can target large indications, such as obesity. Eli Lilly believes this too, signing a $1B+ multi-year deal with Haya earlier this week to apply Haya’s advanced RNA-guided regulatory genome platform to support preclinical drug discovery efforts in obesity and related metabolic conditions.

Haya's unique approach may pave the way for new genetic medicines that actually modify disease cell states — and Lilly's buy in may be a sign that big pharma ready to dive deeper into the emerging field of epigenetics. It's early days, but also an important step towards the promising future of precision medicines. —Karen Langhauser

China's continued crackdown on pharma

China's recent detentions of AstraZeneca employees amid a broader tightening of its anti-spying laws inevitably raises alarm among foreign companies operating in the country.

Passed in July of 2023, China’s amended Counter-Espionage Law extends the scope of activities considered espionage, covering not only state secrets but also any information related to national security. This expansion has placed a spotlight on foreign companies, especially in industries like pharma where access to sensitive data or new technologies could be considered a national security risk.

The regulations have also heightened concerns about data privacy and intellectual property. Companies operating in China are required to implement stringent measures to protect data, particularly patient information in the case of pharma companies like AstraZeneca. Foreign companies must now balance the challenges of maintaining compliance with Chinese law and their global operations, which may have different legal standards for data protection.

Beyond data concerns, China’s anti-spying laws also crack down on activities related to drug imports and clinical trials, as seen in the allegations against AstraZeneca’s oncology division. Foreign firms that once had more flexibility in importing medical treatments and conducting clinical trials are now subject to stringent approval processes, leaving little room for error or unapproved practices.

The broader implication of China’s anti-espionage crackdown is its effect on foreign investment and operations. Recent cases, such as the Japanese executive detained from Astellas Pharma, is the perfect example of the risks that multinational companies face in China’s increasingly controlled business environment.

With this legal framework that allows for the interpretation of some data-related activities as espionage, companies are forced to tread carefully, knowing that any misstep — intentional or not — could result in serious legal consequences. The growing scrutiny on foreign companies sends a clear message: the Chinese government will defend and prioritize its national security interests, even if it comes at the expense of foreign business relations. — Andrea Corona