Ming-Hei Tai, PharmD, BCOP’s Post

The BIOSECURE Act is a game-changer for the US biopharma industry, impacting over 120 drugs in development, many partnered with Chinese companies. The bill mentions major Chinese companies WuXi AppTec, BGI, MGI, and Complete Genomics along with their subsidiaries, parents, affiliates, and successors, citing them as risk to US national security. In addition, the bill aims to prevent US biopharmaceutical companies that collaborate with these Chinese companies “of concern” from accessing US federal funding mechanisms such as the contracts, loans, and grants. In May 2024, US lawmakers revised the BIOSECURE Act, setting a deadline of January 1, 2032 for US biopharmaceutical companies to end their contracts with the Chinese companies. This creates a HUGE opportunity for strategy consulting firms! Here's why: Biopharma scramble for new partners: US companies need alternative CDMOs before the 2032 deadline. ⏳ Shifting landscape: Indian CDMOs are well-positioned, but domestic options might also rise. In particular, CDMOs such as Cipla, Syngene, and Aurobindo may be well-positioned for increased growth due to their cost-effectiveness and highly skilled workforce. Strategic guidance in demand: Biopharma companies need expert help navigating this complex situation. #LifeSciences #BIOSECUREAct #CDMO #StrategyConsulting #GlobalData Figure below is the total number of active innovator drugs by highest development stage involved in CSAs or strategic alliances between US-based companies and Chinese companies covered by the BIOSECURE Act, public and private companies

The BIOSECURE Act could jeopardize the drug supply for millions of Americans by limiting U.S. biotech companies' ability to work with Chinese CDMOs. This legislation, if passed, would halt federal contracts and grants to companies partnering with specific Chinese firms. Key Insights - ▪️ Supply Chain Impact: Critical drug production and development services could be disrupted. ▪️ Industry Concerns: Major players like WuXi AppTec would be directly affected. ▪️ Legislative Power: The White House would determine which companies are blacklisted. Questions to Ponder: ▪️ How will this legislation impact drug availability and prices? ▪️ What alternatives exist for U.S. biotechs if Chinese CDMOs are off the table? ▪️ How can the U.S. balance national security with the need for a stable drug supply? #Biopharma #DrugSupply #HealthcarePolicy #BIOSECUREAct

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

Drug shortages are on the rise and they're lasting longer. Economic pressures and broken contracts have made the supply chain increasingly fragile. With global elections just around the corner, the problem is likely to worsen. Since January, the USP has been calling for change, but will it happen soon enough? As an industry, there needs to be collective action. But we also need individual action. Companies diversifying their supply chains won't fix the problem but it will help mitigate against it until more widespread changes are brought in. #Biotech #Pharma #SupplyChain

With the recent crackdowns on Chinese companies, many industries have shifted away from working with them and towards alternative options. The electronic industry made the transition to Taiwan years ago, reaping numerous benefits. Should the pharmaceutical industry follow suit? If you're currently working with WuXi and seeking an alternative, let's talk! Check out this article on WuXi's role in the biopharma industry: https://lnkd.in/dHvtU6_k

🔬 Attention U.S. Biotech and Pharma Professionals: Major Industry Shifts on the Horizon? 🧪 The ongoing scrutiny of Chinese CDMOs, particularly WuXi AppTec, could reshape our industry landscape. Here's what you need to know: 1. The BIOSECURE Act, if passed, could force U.S. drugmakers to cut ties with certain Chinese biotech companies by 2032. This affects over 120 U.S. biopharma drugs currently partnered with these firms. 2. WuXi AppTec's deep integration in U.S. pharma (involved in developing ~25% of drugs used in the U.S.) means any restrictions could have far-reaching effects on drug development pipelines. 3. Indian CDMOs are positioning themselves to potentially fill the gap. With a market estimated at $22 billion and growing, they're ramping up investments in capacity and capabilities. 4. However, challenges remain. Indian CDMOs may face hurdles in small molecule production and need to address quality concerns. 5. We might see a push towards domestic U.S. CDMOs as concerns grow about offshore dependencies. As industry professionals, we need to stay ahead of these potential shifts. How is your organization preparing for possible changes in the CDMO landscape? #Biotech #Pharma #CDMO #DrugDevelopment #RegulatoryChanges

Thoughts on this? >> WuXi became a critical partner to biopharma companies. They’re not ready if the US cracks down >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharma #biotech #healthcare #pharmaceutical #productmarketing

🚨 U.S.-China Pharma Industry Shake-Up 🚨 The U.S. Congress is considering a bold move that may significantly impact the pharmaceutical sector: 🎯 Target: A bill proposes to blacklist Chinese biotech firms, like BGI and WuXi AppTec, involved in affordable drug development. 🚨 Concern: Aimed at protecting health data, the #BiosecureAct could disrupt U.S. drug companies reliant on Chinese contract manufacturing. - Impact: Potential increase in drug development costs and challenges in drug availability. - Market Reaction: Shares of WuXi AppTec have dropped nearly 50%. - Beneficiaries?: Companies like Thermo Fisher Scientific and Charles River Laboratories could gain, but overall industry capacity remains tight. It's a delicate balance: ensuring national security while maintaining a resilient drug supply chain. The path forward? Uncertain. 🧭 What are your thoughts? 👇 https://lnkd.in/e6F3wHfN

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