Focus on CHK and US stocks

Long-awaited big counterattack! The Pharma Industry of Mayingjiu announced a big news! The market believes that the US "Biosafety Act" has been technically aborted.

券商中國 · Jun 12 14:13

6月12日上午，医药外包概念股集体大涨，$药明生物 (02269.HK)$大涨超13%，$药明康德 (02359.HK)$、$康龙化成 (03759.HK)$、$泰格医药 (03347.HK)$、$凯莱英 (06821.HK)$、$金斯瑞生物科技 (01548.HK)$等股票亦涨幅巨大。

那么，饱受美国《生物安全法案》攻击的CDMO板块缘何会突然崛起？原因可能还是与此法案有关。昨晚美国《生物安全法案》的HR8333提案在纳入NDAA立法过程中受阻。市场认为，该法案已经技术性流产。对于药明康德等一众CDMO公司而言，是重大利好。

考虑到美国制药行业对中国的依赖，修订后的法案给予企业八年的宽限期来脱离中国公司，但业内专家对这段时间是否足够进行这样的过渡存在分歧。那么，事情究竟如何演绎？

一则大消息

当地时间5月15日上午10时，美国众议院监督与问责委员会针对最新修订的《生物安全法案》草案（编号：HR8333）召开了听证会，以决定是否将该法案推进到下一个议程。听证会上，委员会成员对法案条目展开辩论，并提出修改意见。最终该草案以40比1的赞成票获通过。3月6日，美国参议院国土安全和政府事务委员会以11∶1的投票结果，通过了参议院版《生物安全法案》草案（S.3558）。但该法案的立法似乎并未有想象中的那么顺利。

券商中国记者获悉，昨天是《2025财年国防授权法案》（NDDA）是否纳入HR8333提案的日子，但却并未见到预期中的美国《生物安全法案》，也就是说，这个法案仍未纳入NDDA，立法还有变数。市场也将此解读为：该法案立法已经落空。

有大V称，被重新编号为454的原HR8333提案，状态并未更新为“made in order”，而是依然保持“提交”状态，也即说，该提案不仅没有通过纳入NDAA的第一步，甚至直接被忽视了。该项立法可能已经技术性流产。受此利好刺激，医疗外包行业集体大涨，药明生物狂飙近16%，药明康德港股猛涨超9%。

立法的阻力

那么，这个板块的压力是否就此消失呢？这项立法的阻力来自何方？

今年5月，据路透社报道，美国立法机构修改了“限制药明康德及中国生物科技公司的法案”，拟给予更多时间切断两国生物公司之间的联系，该法案将要求美国公司在2032 年之前结束与这些公司的合作。但美国业内专家对这段时间是否足够进行这样的过渡存在分歧。

行业组织生物技术创新组织于5月发布了一项调查，强调美国制药和生物技术公司对中国合同开发和制造组织 (CDMO)的严重依赖，并警告不要过早断绝关系。调查发现，在接受调查的134家美国公司中，有超100家与一家中国本土或中国所有的制造商签订了至少一份合同或产品协议。报告称，数百万人依赖中国制药公司。

虽然中国有多家CDMO，但药明康德是对美国制药公司最重要的公司。其客户范围从新兴生物技术公司到礼来公司等行业巨头。律师事务所 Arnold & Porter 全球生命科学行业业务主席 Daniel Kracov表示：“一些报告显示，他们与20家最大制造商中的19家有合作。”

药明康德和法案中列出的其他公司一再否认美国立法机构的指控。“需要明确的是，药明康德没有人类基因组学业务，我们也不收集人类基因数据，”一位发言人曾在一封电子邮件中表示。“与业内许多人一样，我们担心该法案对美国在生物技术创新、药物开发和患者护理领域的领导地位产生更广泛的影响。”

此外，多家美国生物技术公司近期已在财报中披露了《生物安全法案》可能对其业务产生的影响。Iovance Biotherapeutics公司最近获得了FDA批准，可开发一种用于治疗转移性黑色素瘤的过继细胞疗法，该公司已聘请药明康德生产商业规模的疗法。Iovance 在最近提交给美国证券交易委员会的文件中表示，该法案将影响其药物生产。

另一家公司Cabaletta Bio正在开发一系列嵌合抗原受体T细胞产品，并已聘请药明康德。该公司在一份文件中表示，药明康德的终止或未能履行合同将扰乱Cabaletta的运营。Cabaletta表示：“在建立自己的制造工厂之前，我们打算继续依靠其他第三方来满足我们未来的制造需求。”

当然，上述立法被解读为技术性流产，并不意味着后续不会被重新提及。近期，仍有外媒提及“617之前投票表决”一事。不过，在程序上，仍有数道关卡要过。

从行情上看，疫情过后，医药股基本上也走向持续低迷。再加上生物安全法案的一再扰动，整个板块的可投性大幅衰减。那么，医药股近期是否有机会？有机构认为，一季度可能是医药阶段性业绩低点，二三季度整体拐点或将来临。

编辑/tolk

On the morning of June 12th, contract research organization stocks rose collectively.$WUXI BIO (02269.HK)$They surged more than 16%, hitting the upper limit, and WuXi AppTec's Hong Kong-listed company also rose by more than 9%.$WUXI APPTEC (02359.HK)$, $PHARMARON (03759.HK)$, $TIGERMED (03347.HK)$, $ASYMCHEM (06821.HK)$, $GENSCRIPT BIO (01548.HK)$So, is the pressure on this sector now gone? Where does the resistance to this legislation come from?

In May of this year, according to Reuters, the US legislative body modified the "Act Restricting WuXi AppTec and Chinese Biotech Companies" to give more time to sever the ties between the two countries' biotech companies. The Act will require US companies to end their cooperation with these companies by 2032. But there is disagreement among US industry experts about whether this time is sufficient for such a transition. The industry organization Biotechnology Innovation Organization released a survey in May emphasizing the serious dependence of US pharmaceutical and biotech companies on Chinese contract development and manufacturing organizations (CDMOs), and warning not to cut off the relationship prematurely. The survey found that more than 100 of the 134 US companies surveyed had signed at least one contract or product agreement with a Chinese local or Chinese-owned manufacturer. The report says millions of people depend on Chinese pharmaceutical companies.

Although China has multiple CDMOs, WuXi AppTec is the most important company for US pharmaceutical companies. Its clientele ranges from emerging biotech companies to industry giants like Eli Lilly and Co. Arnold & Porter's Global Life Sciences Division Chairman Daniel Kracov said, "Some reports show that they work with 19 out of the top 20 manufacturers."

The pressure on this sector probably has not yet disappeared and the resistance to the Act comes from many directions.

A big news. At 10 a.m. local time on May 15th, the House Oversight and Accountability Committee held a hearing on the latest revised draft of the Biosecurity Act (HR8333) to decide whether to move the Act forward to the next agenda. Committee members debated the Act's provisions and made suggestions for amendments. Finally, the draft was passed with 40 votes in favor to 1 against. On March 6, the Senate Homeland Security and Government Affairs Committee adopted the Senate version of the Biosecurity Act (S.3558) with a vote of 11:1. But the passage of the Act does not seem to have been as smooth as expected.

Yesterday was the day when the NDAA was to be included in the HR8333 proposal, but the expected Biosecurity Act was not seen, in other words, the legislation is still subject to change. The market also interpreted this as the legislation having fallen through.

According to some influential people, the original HR8333 proposal which was renumbered as 454 has not been updated to the "made in order" status, but remains in the "submitted" status. This means that the proposal not only did not take the first step in NDAA, but was also directly ignored. This legislation may have already been technically aborted. Stimulated by this bullish news, the medical outsourcing industry has collectively risen sharply. Wuxi Bio has soared nearly 16%, while Wuxi AppTec's Hong Kong stocks have surged more than 9%.

Iovance Biotherapeutics was recently granted FDA approval for a cell therapy for the treatment of metastatic melanoma and has hired WuXi AppTec to produce the commercial-scale therapy. Iovance stated in a recent filing with the SEC that the Act will affect its drug production.

So, has the pressure on this sector disappeared? Where does the resistance to this legislation come from?

This year in May, according to Reuters, the US legislative body modified the 'Act Restricting WuXi AppTec and Chinese Biotech Companies' to give more time to sever the ties between the two countries' biotech companies. The Act will require US companies to end their cooperation with these companies by 2032. But there is disagreement among US industry experts about whether this time is sufficient for such a transition.

An industry organization, the Biotechnology Innovation Organization, released a survey in May emphasizing the serious dependence of US pharmaceutical and biotech companies on Chinese contract development and manufacturing organizations (CDMOs), and warning not to cut off the relationship prematurely. The survey found that more than 100 of the 134 US companies surveyed had signed at least one contract or product agreement with a Chinese local or Chinese-owned manufacturer. The report says millions of people depend on Chinese pharmaceutical companies.

Although China has multiple CDMOs, WuXi AppTec is the most important company for US pharmaceutical companies. Its client base ranges from emerging biotech companies to industry giants like Eli Lilly and Co. Arnold & Porter's Global Life Sciences Division Chairman Daniel Kracov said, "Some reports show that they work with 19 out of the top 20 manufacturers."

WuXi AppTec and other companies listed in the Act have repeatedly denied the accusations of the US legislative body. "It should be clarified that WuXi AppTec does not have a human genomics business and we do not collect human genomic data," said a spokesperson in an e-mail. "Like many others in the industry, we are concerned about the broader impact of this Act on US leadership in biotech innovation, drug development and patient care."

In addition, several US biotech companies have recently disclosed in their financial reports the impact the Biosecurity Act may have on their business. Iovance Biotherapeutics recently received FDA approval for a cell therapy for the treatment of metastatic melanoma and has hired WuXi AppTec to produce the commercial-scale therapy. Iovance stated in a recent filing with the SEC that the Act will affect its drug production.

Another company, Cabaletta Bio, is developing a series of chimeric antigen receptor T-cell products and has hired WuXi AppTec. The company stated in a document that the termination or failure of WuXi AppTec to fulfill the contract would disrupt Cabaletta's operations. Cabaletta said, 'Before building our own manufacturing facility, we intend to continue relying on other third parties to meet our future manufacturing needs.'

Of course, the above legislation is interpreted as a technical abortion and does not mean that it will not be mentioned again in the future. Recently, some foreign media mentioned the 'vote before 617', but there are still several checkpoints to pass in the process.

Looking at the market, after the epidemic, pharmaceutical stocks are basically in a sustained slump. Coupled with the repeated disturbances of the Biosafety Law, the investment value of the entire sector has significantly declined. So, is there an opportunity for pharmaceutical stocks recently? Some institutions believe that the first quarter may be the low point of the pharmaceutical stage performance and the overall turning point may come in the second and third quarters.

Editor/tolk

The translation is provided by third-party software.

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Focus on CHK and US stocks

久违的大反攻！药明系，传来一则大消息！市场认为美《生物安全法案》已经技术性流产

Long-awaited big counterattack! The Pharma Industry of Mayingjiu announced a big news! The market believes that the US "Biosafety Act" has been technically aborted.

一则大消息

立法的阻力

The pressure on this sector probably has not yet disappeared and the resistance to the Act comes from many directions.

Iovance Biotherapeutics was recently granted FDA approval for a cell therapy for the treatment of metastatic melanoma and has hired WuXi AppTec to produce the commercial-scale therapy. Iovance stated in a recent filing with the SEC that the Act will affect its drug production.

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