YoonHwa A.’s Post

The U.S. Biosecure Act is a significant legislative development aimed at limiting American pharmaceutical and biotechnology industries' interactions with certain Chinese contract development and manufacturing organizations (CDMOs), notably those identified as national security concerns. Companies targeted by this act include prominent firms like WuXi AppTec and WuXi Biologics, as well as genome sequencing companies like BGI, MGI, and Complete Genomics. Impact on Chinese Contract Manufacturing: The Act is poised to reshape relationships between U.S. biopharma companies and Chinese contractors. With the legislation requiring U.S. companies that receive federal funding to sever ties with specified Chinese firms, this could lead to significant disruptions in the pharmaceutical supply chain. For instance, WuXi AppTec, a major player in the sector, has been involved in the development of a significant portion of drugs used in the U.S., highlighting the potential scale of impact. Implications for Taiwan's Biotech Industry: Taiwan's biotech sector could find both challenges and opportunities in this shifting landscape. As American companies begin to divest from Chinese partners, Taiwanese biotech firms could position themselves as alternative partners, leveraging their technological prowess and capacity for innovation. However, Taiwan's firms will need to navigate the geopolitical sensitivities and ensure compliance with U.S. regulations, which may require strategic adjustments and enhancements in their operations. Future Prospects: The passage of the Biosecure Act could catalyze a broader reevaluation of global biotech partnerships, potentially benefiting countries like Taiwan that are seen as more geopolitically stable and technologically advanced. However, the transition could also be fraught with uncertainties, as U.S. companies might face challenges in quickly replacing Chinese CDMO capacities with those from Taiwan or other countries, potentially leading to delays and increased costs in drug development[. As the situation evolves, Taiwanese companies would be well-advised to monitor developments closely and explore strategic partnerships that could fill the gaps left by Chinese firms, while aligning closely with international standards and U.S. regulatory expectations. #CDMO #biosecureact #WuxiCDMO

Currently, in the US House and Senate, a potential BIOSECURE Act is on the table. This Act while not finalized or implemented yet, will likely affect US drug and biotech companies and their relationships with China (and to a much lesser extent our dealings with other countries of concern like Cuba, Russia, and North Korea). There are concerns that the transmission of sensitive medical data may allow China and other adversarial nations to access vast amounts of American genetic information, intellectual property, and other critical data. This appears to be a reaction to China’s HGRAC regulations, which govern the transfer of genomic data from China to Western countries. If this legislation passes, US government federal contracts, loans, and grants will no longer be granted to American drug/biotech firms that use biotech equipment or services from China when fulfilling government contracts. Read more: https://lnkd.in/gB-cxzEq

#Congress is focused on the #BIOSECUREAct's goal of ensuring taxpayer dollars are not used to subsidize certain Chinese #biotech companies. But, lawmakers are not considering the repercussions for America's #biopharma industry. It’s time for lawmakers to fund our nation's #supplychain independence from #China by bolstering U.S. domestic #manufacturing capabilities. https://lnkd.in/g4nKkKAX #nationalsecurity #biotechnology #pharma #pharmaceuticals #USChinarelations

I try to stay away from posting about negative or political topics, but I do want to draw attention to a specific piece of legislation as it makes its way through the US Congress. It is the BIOSECURE Act. I know there are a lot of geopolitical tensions between the #USA 🇺🇸 and #PRC 🇨🇳, but I think we need to focus on the Positives of a working relationship between these two great nations. The #biopharma industry is one of these positives. There is a lot of trade that goes both ways, and the quality of health of millions/billions of people (no joke) is on the line. I also don't mean to be an alarmist, but WuXi AppTec / WuXi Biologics will not be the only group impacted. If you're a Chinese Company, you don't want to be on the BIOSECURE Blacklist. If you're an American Company, you don't want to get caught doing business with a company on the BIOSECURE Blacklist. There will be far reaching ramifications to many #research and #academic institutions due to, for instance, the funding restrictions built into the #Biosecureact There are magnificent #cdmo facilities dedicated to the production of #biologics that will be hindered by this. #Startups need to make every dollar stretch a mile; #bigpharma has complicated supply chains intertwined with #China and its #factories ; Supply chains dedicated to #insulin production and distribution (destined for #diabetes patients across the globe) will be deleteriously impacted; and Advancements in Cell and #genetherapies will slow down. I don't want those things to slow down! I think the crux of the problem and root cause of most people's fears (on both sides of the Pacific Pond) is Data Integrity. Who has access to the #ip and #patientdata , and how do we (As an Industry) ensure that the governments (Both) don't overstep their respective #regulatory Agency's reach? I have worked with individuals and companies from both the US and China, and you can find wonderful people in both. I believe the Pharmaceutical Industry is no battleground for a Proxy War. How do we keep it a friendly competition competition? No cheating. #dataintegrity #uschinarelations #medicine #supplychain #cherrywithchina #uscongress #congress #fda #regulatoryaffairs #lnp #pharmaceuticals #pharmaceuticalindustry #investmentinsights #biopharmaceuticals https://lnkd.in/dWSdBj5v https://lnkd.in/dRm24PPT https://lnkd.in/dbevRiWS https://lnkd.in/dFdnjAk4

The U.S. BIOSECURE Act: A significant opportunity for Indian CDMOs On September 9, 2024, the U.S. House of Representatives passed the BIOSECURE Act, which bans American drugmakers from partnering with specific Chinese biotech firms namely, BGI Genomics, MGI Tech, Complete Genomics, WuXi AppTec, and WuXi Biologics. The Act is now headed to the U.S. Senate for final approval. As per the Act, companies that engage in collaborations with the above-mentioned entities will be ineligible for grants, loans, and contracts from federal agencies. The legislation's main objective is to prevent the exploitation of U.S. genomic data and intellectual property theft. With the ban targeting major Chinese players, U.S. drugmakers now would have to look out for alternative suppliers. The Act sets a deadline of 2032 for U.S. companies to diversify their supplier base. The new law is expected to have a significant impact across the industry, with Indian CDMOs (Contract Development and Manufacturing Organizations) potentially benefiting the most. Experts predict significant development for India's CDMO sector, which currently accounts for just 2.7% of the worldwide market (Source: The Financial Express). With China controlling 8% of the global CDMO market, this development offers Indian businesses a huge chance to challenge China's hegemony and increase their market share. Several Indian pharmaceutical companies are expected to gain from this new development, as indicated in their first quarter concalls, including the likes of Divi's Labs, Laurus Labs, Neuland Laboratories and Syngene to name a few. What do you think of this development? Comment your views below and follow for more such insightful content. #healthcare #biopharma #pharmaceuticals

US CONGRESS ASKING FBI TO INVESTIGATE CHINESE PHARMACEUTICAL COMPANIES The response will not be positive for the companies! And no……. geopolitics will NOT get any better after the US Elections in 5 months! “We are trying to invest in companies which are in China for China,” …We are aware of the geopolitical stress that’s going on. If a company has a lot of exposure outside of China, there is a risk factor.” Amit Kakar, Head of Novo Holdings Asia told Endpoints News in May, on the sidelines of the Asia Summit on Global Health in Hong Kong. For China in China and completely separate ex-China…. principal two options. #china #pharmaceuticals #biosecureact #FBI #USCONGRESS #cmo #cdmo #cro #endpointsnews #genscript #legendbiotech #wuxiapptec #wuxibiologics #novoholdings https://lnkd.in/eSkMN-Sh

“New modalities, underpinned by scientific breakthroughs in the past decade, are achieving clinical successes and providing treatments for patients with previously unmet medical needs. Meanwhile, externalities such as government initiatives to contain healthcare costs, the sustained high cost of capital, and global geopolitical disputes are putting a brake on investor appetites for the sector,” states Henry Levy, President of Life Sciences & Healthcare, Clarivate. A new article published by pharmaphorum, discusses the current state of the #pharamaindustry and the trend of novel drug approvals steadily increasing. Read more on which potential drug approvals the industry should watch for this year, as highlighted in the recent Drugs to Watch report, here: https://lnkd.in/g7aigzip #drugdiscovery #DrugstoWatch #FDA #healthcare

Recently the FDA altered clinical guidance for drug safety, now requiring drugs to induce less than 3mmHG increases in blood pressure in a 24-hour period. 👩🔬👨🔬 Many researchers are wondering how this may eventually impact preclinical research and whether their current methods are up to par. 🤔 Rest assured, DSI’s pressure sensing technology provides the high-quality data you need for efficient drug discovery 💊 and development with gold standard level performance and reliability in both acute and long-term studies. Check out this technical note to learn more.📝⬇️ #pressuresensingtechnology #researchscience #preclinicalresearch Learn more here 🌐https://lnkd.in/gX4Jfbck

How Good Are New Drugs Compared to Previous Treatments? A question as old as the modern drug industry is about the true benefit provided by new treatments. This is an important argument to justify the high cost of newly approved drugs compared to those available in the prior days and years. A study by researchers in Europe raises some interesting questions about the added clinical benefits to patients from new drugs. Read More: https://lnkd.in/gnUemuA4 Author: Mukesh Kumar, PhD, RAC, | CEO, FDAMAP #fda #drugs #drugdevelopment #newdrugs #moderndrugindustry #newdrugsapproved #fdaregulations #fdacompliance

💊 Macroeconomic forces can only carry the biotech sector so far—innovative new drugs, and the study data that supports them, are what sustains investors’ attention. Here are 10 imminent clinical trial readouts to watch as we open up the New Year. #clinicaltrials #drugdevelopment #drugdiscovery