BioSpace’s Post

WITH 62% OF REVENUE FROM THE US, CHINESE COMPANY IS TURNING TO LOBBYING TO AVOID WASHINGTON IMPOSED DECOUPLING Because of the national strategic research and supply chain implications, Chinese Contract Research, Development and Manufacturing (CDMO) company, WuXi, has been targeted by Congressional Committees for a decoupling of US based companies from using their services. This has yet to be formalized by Congress and grandfathering of existing projects have been proposed. In Wuxi’s recent corporate presentation, the company made note as follows: “The Company strongly disagrees with any preemptive and unfair designation of us as a named “biotechnology company of concern” without due process. The Company fully complies with the laws and regulations in the countries and regions in which we operate, and is working diligently to engage with U.S. policymakers and demonstrate that: The Company does not have a human genomics business and does not collect human genomic data in any of our businesses. The Company never transferred any data or intellectual property of U.S. customers to 3rd parties without customers’ authorization. The Company is not affiliated with any political party, government, or armed forces thereof. The Company has not posed, does not pose and will not pose a national security risk to any country. The Company has not been subject to any sanction by the U.S. government agencies.” As viewed by Washington, the PROBLEM remains that as a Chinese Company, Wuxi is subject to absolute oversight and control upon request by the CCP. Both by repeated actions and voice, Xi’s CCP has, and continues to make clear, that the United States is an alien enemy target, despite trade ties. All the lobbying in the world will not change this reality. Complete separation of Ex-China operations into an independent and separate entity is the only way to optimize corporate assets and competitive advantage. Considering the long-term phased nature of the CDMO model, WuXi needs to achieve this as soon as possible. #wuxi #china #biosecureact #CDMO #CMO #CRO #pharmaceuticals #drugs #manufacturing #clinicalresearch #us #biospace #bloomberg #ustr #uscongress #cifus https://lnkd.in/gUy8uS4F

Passing of the #BiosecureAct through the U.S. House is causing noticeable market reactions. WuXi Biologics saw a sharp drop of 9.2% in its stock, while Samsung Biologics surged by around 4%. The Koreans clearly stand to benefit from the U.S. clients’ shift away from Chinese CDMOs. All other major players in the #CDMO space saw positive stock movements too as global companies look to diversify their supply chains. This legislation is expected to open new opportunities for CDMOs in the U.S., Europe and Asia, first of all, in Korea and India. However, the competition will be fierce, and players will need to navigate tighter regulations and cost pressures to capitalize on this changing landscape. Twogene, our #Thailand-based PIC/S compliant #cellandgenetherapy focused #plasmidDNA services provider, is closely following these developments as this shift could bring both challenges and significant opportunities.

Disruptions in global pharma supply chains during the pandemic showcased the industry's reliance on China for not only outsourced manufacturing activities but also for key starting materials and APIs at the very top of the pharma supply chain. The unhealthy reliance on China was met by an industry consensus to prioritize supply chain resilience to de-risk and mitigate global supply chain failures in the midst of black swan events. Are we again, on the precipice of another serious global pharmaceutical supply chain disruption? As the US cracks down on China through the BioSecure Act, this should be seen as a wake up call to the wider industry to refocus their attentions on supply chain diversification.

https://lnkd.in/g8YAY559. These kinds of things undo dozens of announcements of #FTZ this and FTZ that and #negativelist this and #negativelist that. Profits can do down; #IPR out the door; and assets dissipated. But staff and, worst of all, execs (not here) arrested.... well, that's over the top... #FDi #espionage #Japan Astellas Pharma Reuters #pharmaceuticals #divestment #politicalrisk #regulatoryrisk #ChinaJapanrelations

On August 16th, Taimei Technology co-organized the "Excellence in Clinical Strategy and Operations Summit" in Shanghai, alongside PharmaKo, under the guidance of the Shanghai Biopharmaceutical Industry Promotion Center. The event successfully brought together nearly 100 clinical operations professionals to discuss and share insights on efficient clinical operations in the era of globalized clinical research. Gary MA, Senior Vice President of Taimei Technology, emphasized in his keynote: "Chinese pharmaceutical companies face multiple challenges in global digitalization. A clear long-term strategy, sustained digital investment, and the right digital partners are essential. With reliable R&D capabilities, cost-effective solutions, sustainable investments, and exceptional responsiveness, we are committed to supporting companies on their global journey." We have established three global delivery centers, providing cutting-edge digital solutions across over 200 international projects. Our localized, multi-time zone, and multilingual support ensures seamless and reliable assistance for the global expansion of innovative pharmaceuticals. Driven by a commitment to pioneering digital transformation, we foster strategic partnerships that empower pharmaceutical companies to thrive on the world stage. #TaimeiTechnology #eClinicalSolutions #DigitalTransformation #ClinicalResearch #Globalization #EDC #eCollect6 #TaimeieCollect6 #AI #Partnership #ClinicalTrials

🌍 Internationalization of Chinese IVDs🌍 Opportunistic growth opportunities from covid-19 have helped fuel rapid growth for Chinese companies not just domestically, but also in overseas markets.  In recent years, several IVD companies have made notable strides in internationalization. For instance, Mindray has obtained an impressive total of 3,914 registration certificates worldwide, with 3,158 coming from overseas markets. Similarly, Maccura has secured 2,467 registration certificates globally, including 1,962 from international markets, while Snibe holds 1,493 registration certificates globally, with 1,127 obtained from abroad. #ChineseIVD #Internationalization #IVDRegistration

EXCERPTS: At a time of heightened geopolitical tensions between the U.S. and China, Eli Lilly’s CEO said the Indianapolis-based company remains committed to the Chinese market. David Ricks outlined his commitment during a Thursday meeting with China’s Commerce Minister Wang Wentao. Ricks’ visit to China comes as regulators in the country review several Lilly drug applications. These include weight loss drug Zepbound, Alzheimer’s disease therapy donanemab and BTK blood cancer med Jaypirca. Further, the meeting comes as a draft bill targeting certain Chinese biopharma companies advances in the U.S. Congress. One of the Chinese firms targeted is Lilly’s contractor and partner, WuXi AppTec. The bill, dubbed BIOSECURE Act, aims to block WuXi and other Chinese “biotechnology companies of concern” from getting contracts from federal agencies. If passed in its current form, the bill would also prohibit the targeted firms from working with partners that do business with the federal government, including those who sell drugs to Medicare and Medicaid. COMMENT: While I do not know Lilly's strategy, as mentioned related to my data piece, I can assure you if Washington restricts Big (and small) Pharma in the U.S., they will build up in China.

🔊 The much-discussed BioSecure Act 2024 is anticipated to have a ripple effect, with potential benefits for CDMOs across Asia. 📣 India, South Korea, Taiwan, and Vietnam are expected to be the primary beneficiaries of the BioSecure Act. 📣 With China's CDMO industry currently holding 8% of the global market, India, with its current share of 2.7%, is expected to be the major beneficiary of this act. 📣 While most Indian CDMO companies are seeing an increase in business inquiries, a surge in pilot-scale project orders and requests for quotes from U.S. firms is expected over the next 12-18 months. 🔔 Additionally, other Asian countries like Taiwan and South Korea have also begun preparing to capitalize on the benefits of the act. If you are looking to expand your facility to accommodate future growth, feel free to reach out to representative of Sartorius at your region. #Biosecure Act #CDMO #Asia Biotech Growth.

Such an act is one of the many subtil "protectionism" policies in place in many developped markets, but the ramifications in terms of affordability are the real issue here: how can you maintain a chain of value when one of the link is geopardized?

Embracing the Future: China's Pivotal Role in Global Pharmaceutical Innovation We will celebrate the Chinese New Year on Saturday. It's the perfect moment to examine China's monumental impact on the global healthcare sector. As the second-largest medicine-producing country, China's advancements showcase an inspired fusion of ancient healing wisdom and cutting-edge innovation. In 2021 alone, China's pharmaceutical production reached a staggering $171 billion. This highlights China's indispensable position within the worldwide healthcare ecosystem today. Bolstering this achievement is China's status as the foremost producer of pharmaceutical ingredients and APIs, cementing its role as a volume leader in drug manufacturing. However, China's healthcare landscape is rapidly evolving. Demographic shifts, including a growing middle class, expanded healthcare coverage, and an aging populace, are reshaping the sector. Yet China faces unique obstacles, like a rigorous drug approval process underscoring a commitment to safety, that contribute to delayed access to new treatments compared to other countries. China is reported to have a severe drug lag and median of 3.7-year access gap behind the United States (https://lnkd.in/ecea8Evv) as well as a drop of IND filings (https://lnkd.in/ecMyvwpq). Rather than perceive these challenges as roadblocks, we must view them as opportunities for global collaboration. By co-developing drugs and aligning approval processes, we can expedite worldwide access to life-saving medicines. China's pharmaceutical journey—from its ancient roots in traditional medicine to its latest policy reforms enabling innovation—illustrates a dynamic, future-focused sector. As we celebrate the Year of the Dragon🐉, we can be hopeful that China's contributions to global healthcare will support greater health and wellbeing for all. Wishing you all, a prosperous Lunar New Year! Illustration EMxDE3 #China #Healthcare #Innovation #GlobalHealth #ChineseNewYear #Dragon #Collaboration