Ongoing policy issues in the U.S., including the Inflation Reduction Act and recent proposals under President Donald Trump’s administration, have wide ranging implications for the global biopharmaceutical industry, speakers at Bio Korea 2025 said May 8, including a heightened need for all biotechs to draft regulatory strategies.

Korean pharmaceutical stocks rose across the board May 13, a day after U.S. President Donald Trump signed off on the most favored nation executive order, a drug pricing policy expected to benefit biosimilar makers in the U.S., according to Celltrion Inc.

First quarter 2025 results presentations were the first chance analysts have had to quiz pharma companies in public about their exposure to the threat of U.S. import tariffs and what action they are taking to mitigate the risks.

South Korea’s Ministry of Food and Drug Safety approved 18 biosimilar products in 2024, making it a record year for domestic biosimilar approvals since the agency’s first nod of Celltrion Inc.’s Remsima, a reference product of Remicade (infliximab), in 2012.

Among three Korean biotech companies slated to sell shares on the Korea Exchange this month, Immuneoncia Therapeutics Inc. is the latest to price a ₩33.9 billion (US$24 million) Kosdaq IPO for May 19. Regenerative cell therapy maker Organoid Sciences Ltd. and antibody-drug conjugate specialist Intocell Inc. are also gearing up for respective Kosdaq listings starting next week.

Total biopharma financings for the first four months of 2025 reached $15.48 billion, a 71% decline from $53.49 billion in 2024. Biopharma companies raised $2.4 billion in April 2025, reflecting a 37% drop from March's $3.82 billion.

Jiangsu Hengrui Pharmaceuticals Co. Ltd. is the latest mainland China pharmaceutical company to seek a capital raise on the Hong Kong stock exchange, winning clearance April 28 from the China Securities Regulatory Commission to float new H-shares.

Tightening of U.S. regulation and capital is leading Chinese biotechs to alternative and new models of financing, ranging from cross-border licensing deals, M&As, the so-called newco model and overseas listings.

Europe was a bigger counterpart to China in pharmaceutical dealmaking than the U.S. last year, speakers at Chinabio Partnering Forum said April 23, and the trend is likely to continue in 2025 with the shuttering of U.S. capital and volatility ailing global markets.

Biopharma deal value declined in the first three months of 2025 compared to the previous quarter, but remained above the 2024 quarterly average of $57.63 billion. In the first quarter (Q1), biopharma deals totaled $66.86 billion across 330 transactions, a decrease from $80.65 billion in Q4 2024, which saw 372 deals. However, this was a significant value increase from Q1 2024, when deals amounted to $44.32 billion across 376 transactions.