印度公司能否承接得住欧美创新药玩家的体量？
9月10日，Biosecure Act《生物安全法案》（H.R.8333号法案）靴子落地，众议院以306票赞成、81票反对的投票结果通过该法案。这一结果无疑给名单上的中国企业蒙上阴影。而在这场大国博弈的过程中，印度竟然成为该法案的最大赢家。
实际上，从去年12月以来，美国生物安全法案的热议对整个制药和生物技术行业产生了强烈影响。目前为止，中国一直是亚太地区CRO/CDMO服务的主要领导者，但是一些印度CDMO公司近期表示，在第二季度收到了更多的RFP（询价），对新增业务的实际影响可能需要4~6个月显现。印度目前有100多家CDMO公司，其中的几家头部企业包括Syngene International、Aurigene和Jubilant等。
InCred Healthcare PMS的Aditya Khemka在接受The Economic Times采访时表示，《生物安全法案》一旦实施，与全球创新者做生意的印度制药公司将会受益，以及那些与全球仿制药公司做生意的API制造商。
Aditya Khemka认为，《生物安全法案》背后的逻辑是，中国在医药产品原料供应的垄断地位，令西方国家感到不安。这无疑让印度的CDMO/CRO企业有了立足之地，尤其是那些与全球创新企业有业务往来的公司。
据他分析，未来10年全球的创新药玩家并不会完全从中国转移出去。实际上，他们的真正意图是建立一个可替代的供应商生态系统，即使价格或成本更高。
目前，印度的API出口额约为40亿美元，而中国的API出口额约为400亿美元。两者有10倍的差距。并且，由于医药行业受到监管影响，无法在一夜之间决定改变供应商生态系统或建立替代供应商生态系统，但这将会是未来5~10年内的趋势。
Aditya Khemka指出，在印度之外（尤其在欧洲和美国）拥有生产能力的印度制药公司，将会是《生物安全法》实施后的最先获益者，例如Jubilant、Piramal。后续的受益者将是那些在印度的同类公司。
中国的CDMO可以做些什么？或许我们可以从其他行业中看到一些经验。前几年，苹果公司曾高调宣布加大印度生产。然而，近期的媒体报道显示，苹果转向印度生产并不顺利，并决定将部分产能转向中国。理由很简单，无论是产品质量还是供应链关系，中国的确保持着一定的自身优势。
《生物安全法案》的实施，印度CDMO或许得到机会，但能否承接整个欧美创新药玩家的体量？有一种可能是，印度公司仍需要将一部分业务通过与中国企业合作的形式来实现，并从中进一步获利。正如Aditya Khemka所说，未来10年全球的创新药玩家都不可能完全摆脱对中国的依赖，眼下，我们需要的是整个行业的团结。
Comer Delivers Remarks in Support of Bipartisan BIOSECURE Act
WASHINGTON—Today, House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) delivered remarks on the House floor in support of H.R. 8333, the BIOSECURE Act, introduced by Reps. Brad Wenstrup (R-Ohio) and Raja Krishnamoorthi (D-Ill.). The bipartisan, bicameral bill prohibits U.S. taxpayer dollars from flowing to biotechnology companies that are owned, operated, or controlled by China or other foreign adversaries and specifically names five companies with extensive ties to the Chinese Communist Party. The legislation also prevents federal agencies from procuring any biotechnology equipment or service from such companies.
Below are Chairman Comer’s remarks as prepared for delivery.
Thank you, Mr. Speaker.
I am happy to support H.R. 8333, the BIOSECURE Act.
This bipartisan, bicameral bill prevents U.S. taxpayer dollars from flowing to biotechnology companies that are owned, operated, or controlled by China or other foreign adversaries.
Specifically, this bill names five genomic companies with direct ties to the Chinese Communist Party as biotechnology companies of concern.
The bill then prohibits a federal agency from procuring any biotechnology equipment or service from such companies.
The bill also prohibits federal loan or grant dollars from being used to procure, obtain, or use biotechnology equipment or services from such companies.
The companies named in this legislation create significant risks to U.S. national security.
BGI—one of the named entities—is a CCP biotechnology company and is the world’s largest collector of genetic data.
BGI—alongside its subsidiaries, which are also named in the bill—have been found to conduct research alongside the Chinese military.
WuXi—through its two subsidiaries named in the bill—operates genetic testing centers established in coordination with the CCP, helps carry out research to promote the Chinese-military, and has reportedly stolen U.S. firms’ intellectual property.
The House Oversight Committee has worked hard with outside stakeholders and other Committees of jurisdiction to ensure these national security risks are meaningfully addressed without disrupting medical and pharmaceutical supply chains.
Existing contracts are exempt from the prohibitions in the bill until January 2032 and the bill includes a targeted waiver and exception process.
The bill also exempts biotechnology equipment and services from the bill’s prohibitions that were, but are no longer, produced or provided by a company of concern.
This bill is a necessary step toward protecting American’s sensitive healthcare data from the CCP before these companies become more embedded in the U.S. economy, University systems, and federal contracting base.
I want to thank the bill’s sponsor, Rep. Brad Wenstrup, Chairman of the Select Subcommittee on the Coronavirus Pandemic, for his efforts in ensuring this bill continues to advance.
I also want to thank the Select Committee on the Chinese Communist Party Chairman John Moolenar and Ranking Member Raja Krishnamoorthi, both original cosponsors, as well as the House Oversight Committee’s Ranking Member Jamie Raskin and the Senate Homeland Security Committee Chairman Gary Peters, and their staff, for their hard work on this legislation over the past year.
I urge all of my House Oversight colleagues to support this critical national security bill.I reserve the balance of my time.
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