Foreword Contents Western multinationals acquired most globalrights to novel antibody-drug conjugates(ADCs) and oncology drugs – a scenario barelyimaginable just five years ago. In-person attendance at conferences andexhibitions across the Asia-Pacific regionseems to be exceeding pre-pandemic levels,marking a robust rebound in business traveland a surge in tourism, especially in Japan. Brought to you by Supported by favorable policies, regulatoryframeworks and homegrown expertise andcapabilities, China’s rapid rise as a source ofglobal pharma innovation has been the mostremarkable APAC success story of the past fewyears, and the large deals validate this. Obesityis now emerging as a new focus for regionalresearch. Ian HaydockEditor-in-Chief,APACCiteline While signs of post-COVID normalizationare evident, the biopharma sector in the regionhas continued to be characterized over thepast year by a complex mix of factors – somea hangover from the pandemic and othersemerging independently. Despite some improvement, lingeringinvestor uncertainties continued to dominatethe fundraising environment in China and SouthKorea, where few IPOs have occurred thisyear. This partly reflects wider macroeconomicfactors, and heightened investor expectationsfollowing the coronavirus bonanza. India continued to climb the innovationladder as well, marked by rising internationalspecialty sales. Top domestic executivesin India are following in China’s footstepsover the next decade, moving from complexgenerics into more novel modalities and assets. Sponsored by Long-simmering geopolitical tensions,notably between the US and China, havesolidified with the planned US BIOSECUREAct, which casts a large shadow over businessinteractions and threatens the operations oftargeted Chinese firms in the US. South Korea is also pursuing its innovationefforts, with the first US approval of adomestically originated oncology drug. However,some firms faced setbacks in globalizationefforts with the return of novel assets by foreignpartners following pipeline restructuring. Thelong-running doctors’ strike in South Korea alsobegan to have a wider impact. Meanwhile, several major Japanese firmsare cutting thousands of jobs precipitatedby various company-specific factors suchas major patent expirations and pipelinereprioritizations. Yet a reimbursement pricingenvironment long criticized for lacking incentivemay have contributed, with prices continuingto be cut in regular revisions based on cost-effectiveness and sales expansion. While there have been no sizeable APACM&A deals since the last Scrip Asia 100,multiple asset-focused licensing transactionswere dominated by Daiichi Sankyo and Merck& Co. in October 2023 for three oncology ADCsworth up to $22bn. Daiichi’s strategic pivot tocancer continues to be a huge area of successfor the Japanese. ASIA TEAMAnju GhangurdeXu HuDexter Jie YanJung Won ShinLisa TakagiVibha Ravi SCRIP ASIA 100 EDITORSIzabela ChmielewskaJanelle HartAndrea CharlesAndrew Warmington CUSTOMER SERVICES Tel:UK & Europe: +44 203 480 7600US Toll-free: +1 888 670 8900 China’s general economic slowdown,along with ongoing challenges aroundreimbursement, formulary inclusion and pricepressure, is scrubbing off some of the allure.One survey of European firms in China showeda sharp drop in business sentiment. This introduction highlights only some of thetop-line trends from the past year. We hopethe carefully curated selection of data, articlesand analyses in this year’s edition will providedeeper insights built on the expertise of our on-the-ground team, and aid your understandingof this vital, diverse and complex part of thebiopharma world. URL:insights.citeline.com/scrip EDITORS-IN-CHIEF To subscribe, visithttps://www.citeline.com/en/app-insights-trial Ian Haydock (Asia)Nielsen Hobbs (Regulatory)Eleanor Malone (Commercial)Ryan Nelson (Medtech) DESIGN & PRODUCTIONKosh NaranNancy Pham To advertise, contactchristopher.keeling@citeline.com More positively, innovation in Korea andChina continues to develop rapidly. Thisis marked by several major deals in which EXECUTIVE EDITORSCOMMERCIAL All stock images in thispublication are courtesy ofwww.shutterstock.com unlessotherwise stated. Scrip is published by Pharma Intelligence UKLimited (Citeline). © 2024 Pharma IntelligenceUK Limited (Citeline), a Norstella company:All rights reserved. ISSN 0143 7690 Alexandra Shimmings (Europe)Mary Jo Laffler (US) EXECUTIVE EDITORSREGULATORYDerrick Gingery (US)Neena Brizmohun (Europe) CONCLUSION robust post-marketing surveillance, with a focus on ensuringsafety and efficacy profiles.5This high bar for clinical dataand ongoing monitoring can present hurdles for companiesseeking to enter the Japanese market. Biosimilars In Asia: A Strategic ApproachTo Regulatory Requirements In the evolving biosimilars market, a robust, localisedstrategy is critical for meeting regulatory requirements andmanaging risks. Asia’s diverse regulatory landscap