David Deere’s Post

The most consequential piece of health care policy legislation since the Inflation Reduction Act is barreling toward passage. From the lemons of supply-chain shocks and slowed development on new drug development -- to the lemonade of thousands of good, high-paying, clean manufacturing jobs in the US... "Since the bill was first introduced in January 2024, it has had a chilling effect on the industry, pressuring an already strained U.S. supply chain and threatening continued R&D. A recent GlobalData report found the legislation could affect more than 120 U.S. drugs partnered with companies named in the BIOSECURE Act, of which about half are in clinical trials and a third are in early-stage preclinical studies and discovery." The BIOSECURE Act -- independent of the national security necessity argued by it supporters, or the industry-styming downsides associated with it over-correction argued by its detractors -- does have the potential to create good jobs all over the US, if Congress is honest about the lemons and amends the legislation with provisions for making the lemonade.\

The U.S. House of Representatives on Monday voted in favor of the BIOSECURE Act, which would restrict American companies from working with specific Chinese biotech companies— potentially putting more pressure on an already-strained drug supply chain. The legislation gained bipartisan support with the House voting 306–81 to pass it, including 111 Democrats. Still, nearly all of the members of Congress who voted against the bill were Democrats. With Monday’s vote, the BIOSECURE Act will now move on to the Senate where strong bipartisan support is also likely. The Senate Committee on Homeland Security and Governmental Affairs passed a similar bill in in March 2024 with only one dissenting vote. #biotech #biopharma #pharma #China #BIOSECURE

I had previously discussed, from a high level, how this would impact the clinical trial supply chain. see the post here (https://lnkd.in/eGybjaYW); but now that it is coming to fruit, let's get ready with back-up supply chains and better agreements for RSM sourcing.

#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

"The U.S. House of Representatives on Monday overwhelmingly passed the bipartisan bill, which targets WuXi AppTec, WuXi Biologics and other Chinese biotech companies as potential national security risks." While the bill still needs to go through the Senate, it looks likely that it will get passed. If you are looking to re-evaluate your #API #GMP manufacturing for a US based company with almost 40 years of experience, look no further than Ascensus Specialties. From small molecule synthesis, organometallic compound synthesis, high purity metals for cell culture media, and water soluble phosphines, we have a great reputation in support of pharma and biotech in the US. https://lnkd.in/exkt_w8V

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 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

Good read on US #BiosecureAct, passed with overwhelming #bipartisan support. This will go a long way in reducing US #pharma #dependency on China and #improving #supplychain #constraints.The act does provide a cool-off period of 5 years for existing contracts. Will be interesting to see how China retaliates and how this benefits #CDMO players in India. https://lnkd.in/dRFEeQCd

WUXI PROMISES STATUS QUO EVEN AS (NEUTRAL) SWISS NOVARTIS CUTS TIES WITH CHINESE PHARMA CONTRACTORS “With WuXi AppTec’s very existence under threat from proposed biosecurity legislation in the U.S., the Chinese CDMO giant is standing its ground on its quest to preserve its business and “do the right thing,” the company’s CEO, Ge Li, said in the company’s first-quarter earnings report, today.” “Li noted that the proposed legislation could create short-term uncertainty for the company, our customers and the global pharmaceutical and life sciences industry.” … WuXi AppTec remains steadfast in ‘doing the right thing and doing it right” Li said, adding that the CDMO would continue to support its customers against the backdrop of a hazy political climate.” "After defending itself against the “misguided” efforts of the BIOSECURE Act in early February, WuXi AppTec last month tried to assuage investors and customers with a surprisingly upbeat 2024 forecast in which the company predicted it would continue to see revenue growth and expansion projects unfold as planned for the year." To further calm customers about the company’s data protection efforts, WuXi AppTec also pointed out in its first-quarter earnings release that it underwent 748 customer quality audits and inspections in 2023 and achieved a 100% pass rate. The company also received 83 information security audits over the same stretch, which yielded “no critical findings.” (FirecePharma ,Today) "Swiss pharma’s CFO, Harry Kirsch, said on a press call Tuesday during its first quarter financial results. Amid the threat of a looming biosecurity crackdown by the U.S. government against many of those Chinese biotechs, Novartis is now “actively” managing the situation, Kirsch said. So, by the time this comes into effect, we will have no exposure from our planning,” the CFO explained, adding that the situation will be “mitigated in a very reasonable timeframe.” "Kirsch went on to explain that the company is weighing changes to its contracting relationships with Chinese companies “so that we are fully aligned” with potential U.S. regulations." "With Sinophile AstraZeneca CEO Pascal Soriot said in an interview with Bloomberg last month. “And we also are building our presence here in China, so we can actually supply Chinese patients independently…” Global Big Pharma is planning to decouple and exclude Chinese biopharma companies from their global operations. Pledging to “Do the right thing,” while admirable, will prove wholly insufficient in the face of the geopolitics created by Beijing’s actions. #china #pharmaceuticals #drugs #sourcing #supplychains #manufacturing #decoupling #geopolitical #CDMO #CMO #CRO #wuxi #novartis #astrazeneca #phrma #bio #efpia #rdpac #fiercepharma #biosecureact  https://lnkd.in/e-j2CwJR

With the potential passage of the BioSecure Act, much of the conversation centers around its implications for CMC, supply chains, and CDMO operations. But we need to think ahead—how might this affect patient access and drug pricing? As companies seek new suppliers and manufacturing costs rise, could we see an increase in drug prices, especially for critical therapies like biosimilars and cell & gene therapies? These higher costs will also likely play a role in future Medicare drug price negotiations under the Inflation Reduction Act (IRA). While the full impact may take several years to come to fruition, have you followed the supply chain closely enough to see how this might reshape access and affordability? Ensuring that patients continue to access affordable treatments should be a key part of the ongoing discussion. #BioSecureAct #Pharma #PatientAccess #DrugPricing #Healthcare #Biosimilars #CGTx #IRA Precision AQ