“此次修订反映了之前国土安全和政府事务委员会听证会的讨论结果。3月的听证会上，即要求进行对法案进行实质性修改。”熟悉美国国会立法运作的上海元达温斯顿合伙人律师詹凯在采访中告诉财联社记者。①On the 23rd local time in the USA, the US Senate included Amendment S.3558 in the Senate legislative schedule under general orders, and confirmed the new name of the bill, wuxi bio experienced abnormal movement; ②Amendment S.3558 did not include the "grandfather clause" exemption period in the House version of the "Biological Safety Act", nor did it make any changes to the entities involved.
On September 25th, Caixin Society (Reporter Lu A Feng) following the high vote of the House of Representatives on September 10th, the United States Senate also took new action after the House version of the "Biological Safety Act" (H.R.8333) was passed with a high vote.
Caixin reporters learned that on the 23rd local time in the USA, Chairman of the US Senate Committee on Homeland Security and Government Affairs Gary Peters submitted an Amendment S.3558 to the US Senate. The S.3558 bill, previously widely known as the Senate version of the "Biological Safety Act", was passed with a vote of 11 in favor and 1 against at a hearing of the US Senate Committee on Homeland Security and Government Affairs held in March this year.
"This revision reflects the results of previous discussions at the Committee hearing on Homeland Security and Government Affairs. The hearing in March requested substantial modifications to the bill." Shanghai Yuan Da Winston's partner lawyer Zhan Kai, familiar with the legislative operation of the US Congress, told Caixin reporters in an interview.
In this amendment, the S.3558 bill has been officially named the "2024 Law Prohibiting Foreign Access to US Genetic Information". Caixin reporters found that the US Senate Committee on Homeland Security and Government Affairs made some deletions based on the early version, but there was no change in the list of entities involved. wuxi bio does not appear on the list, while wuxi apptec and China Grand Pharmaceutical Group are still listed. (In the House version of the "Biological Safety Act" (H.R.8333), wuxi bio has been mentioned)
In addition, the "grandfather clause" added in the House version of the "Biological Safety Act" (H.R.8333) was also not included in Amendment S.3558.
At a hearing of the US House Oversight and Accountability Committee held in May, the "Biological Safety Act" (H.R.8333) added the "grandfather clause", providing a longer buffer period for US biopharmaceutical companies to do business with Chinese companies involved, extending the exemption rights for existing contracts/products to January 1, 2032. At that time, it was widely believed in the industry that this represented a certain compromise in response to opposition from the US biopharmaceutical industry being perceived by the political sphere.
On September 10th local time in the USA, the House of Representatives voted on the "Biological Safety Act" (H.R.8333), ultimately passing with 306 votes in favor, 81 against, and 44 abstentions. According to the official website of the US Congress, the bill has now been submitted to the US Senate and referred to the US Senate Committee on Homeland Security and Government Affairs.
It is worth noting that the proposer of the 'Biological Security Bill' in the US Senate and House of Representatives previously attempted to include the bill in the 2025 fiscal year National Defense Authorization Act (NDAA), but based on the current legislative progress of the NDAA, the attempt of the 'Biological Security Bill' to hitch a ride has not been successful.
Regarding the name change of Amendment S.3558, both Zhan Kai and Zhao Heng, founder of the medical strategic consulting firm Latitude Health, believe that this represents the US Senate's attempt to downplay the focus on Chinese CXOs in order to reach a majority consensus.
Particularly, wuxi apptec and wuxi bio have previously issued public announcements stating unanimously, 'The company not only does not have a human genomics business, but also none of the company's existing businesses involve collecting human genomic data in the USA, China, or any other region.'
Zhan Kai told Caixin reporters that compared to the original version, Amendment S.3558 will focus on gene-related content and companies, while the specific entities and 'grandfather clauses' involved by the US House of Representatives may become a potential point of contention between the US Senate and House, requiring more time to reconcile differences in the future on this issue.
It is worth mentioning that according to the US Congress website, Amendment S.3558 has been included in the Senate legislative agenda under general orders, with the agenda number 521.
Caixin reporters, after preliminary review of the relevant schedule on the official US Senate website, have not found specific meeting schedules for Amendment S.3558.
The US presidential election is scheduled for November 5th, with some senators up for re-election, and the US Senate has fewer remaining sessions this year. Zhan Kai stated, 'The challenge for this bill to come into effect this year is indeed very high, time is extremely tight. However, we cannot completely rule out the possibility of a standalone bill passing soon or being tied to the year-end NDAA.' Zhao Heng believes, 'There is a greater possibility of standalone legislation.'
In today's market performance, there was abnormal movement in the wuxi group, with wuxi apptec (02359.HK) experiencing a sharp rise at midday, followed by a decline of over 2%; wuxi bio (02269.HK) closed with a 4% increase, while Shanghai Hua Medicine (688114.SH) closed down by 0.24% today.
