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GSK Leaves BIO, Joining Other Major Companies in Withdrawing Membership
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GlaxoSmithKline (GSK; NYSE: GSK), a leading pharmaceutical company based in the UK, has reportedly withdrawn from the US industry trade group Biotechnology Innovation Organization (BIO). This decision follows a similar trend set by Pfizer (NSE: PFIZER), UCB (EBR: UCB), WuXi AppTec (HKG: 2359, SHA: 603259), Takeda (TYO: 4502), and other…
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WuXi AppTec Reports Q3 2024 Revenues of RMB 10.46 Billion Amid Biosecure Act Challenges
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WuXi AppTec Co., Ltd (SHA: 603259), the China-based Contract Development and Manufacturing Organization (CDMO) facing potential restrictions under the Biosecure Act—set to ban drugmakers with U.S. government contracts from utilizing Chinese services post-2032—reported its financial results for the first three quarters of 2024. In the third quarter, revenues reached RMB…
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WuXi AppTec and WuXi Biologics Weigh Asset Sales in US and Europe Over Biosecure Act Concerns
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Reports emerged last week in the Financial Times suggesting that WuXi AppTec (HKG: 2359) and WuXi Biologics (HKG: 2269) are contemplating the sale of certain US and European assets due to the anticipated negative implications of the Biosecure Act, which is currently under review in the US legislative process. Both…
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US House Approves Biosecure Act with Implications for Chinese Biotech Firms
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The US House of Representatives has taken a decisive step towards tightening biosecurity measures, voting 306-81 on September 9, 2024, to approve the US Biosecure Act, specifically the version known as H.R. 8333. This legislation, previously endorsed by the House Committee on Oversight and Accountability, mandates that any company receiving…
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US Congressmen Call for FDA Investigation into Clinical Trials at China’s Military Hospitals
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US lawmakers are intensifying their scrutiny of the involvement of Chinese military hospitals in hosting clinical trials, urging the US FDA to delve deeper into the matter. In a correspondence addressed to FDA Commissioner Robert Califf and endorsed by key members of the bipartisan US House Select Committee on the…
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WuXi AppTec’s H1 2024 Financials Reflect Decline Amid Biosecure Act Challenges
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China-based Contract Development and Manufacturing Organization (CDMO) WuXi AppTec (HKG: 2359) has reported a subdued performance for the first half of 2024, with its financial report indicating a decline in revenues and net profits. Revenues for the period stood at RMB 17.241 billion (USD 2.38 billion), marking an 8.64% year-on-year…
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WuXi AppTec Spends Over USD 360,000 on US Lobbying Amid Biosecure Act Deliberations
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Endpoints News has reported that WuXi AppTec Co., Ltd, (SHA: 603259) a China-based Contract Development and Manufacturing Organization (CDMO), spent at least USD 360,000 on lobbying efforts in the United States during the second quarter of 2024. This period coincided with lawmakers’ consideration of the Biosecure Act and other legislative…
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Consun Pharmaceutical Gets NMPA Go-Ahead for CKD Drug Clinical Trial
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Consun Pharmaceutical Group Ltd (HKG: 1681), a leading Chinese pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to commence clinical studies for SK-08. This Category 1 chemical drug, co-developed with Contract Research Organization (CRO) WuXi AppTec (HKG: 2359), is intended to target…
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WuXi AppTec and WuXi Bio Shares Rally as US Biosecure Act Excluded from Defense Bill
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Shares of Chinese Contract Development and Manufacturing Organizations (CDMOs) WuXi AppTec (SHA: 603259) and WuXi Bio (HKG: 2269) saw a significant surge as the US House Rules Committee decided against incorporating the proposed US Biosecure Act into the critical defense spending bill. The market had been anxiously awaiting the decision,…
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Landmark Biosecure Act Passes US House Committee with 40-1 Vote, Eyes 2024 Enactment
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The US House Committee on Oversight and Accountability has completed the markup process for amendments to the Biosecure Act, voting 40-1 in favor of moving the Act to the House floor for a full vote in both the House and Senate. This marks the final legislative step before the Act…
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BIO Survey Highlights Extensive Dependence on Chinese CDMOs in Life Sciences
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The Biotechnology Innovation Organization (BIO), a US industry trade group, has completed a survey among its members to gauge dependence on Chinese service providers in the life sciences industry. The results, reported by FiercePharma.com, are intended to guide US lawmakers as they prepare to potentially finalize the BioSecurity Act next…
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BioSecure Act Advances in US, Aiming to Curb Ties with Chinese Bioscience Firms
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US legislators are working expeditiously to finalize the BioSecure Act, legislation that, if enacted, would restrict interactions between US companies and several Chinese life sciences firms. According to details obtained by FiercePharma.com from recent amendments to the draft law, existing contracts between US firms and the listed Chinese entities will…
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BIO Surveys Members on China-CDMO Dependence Amid BioSecurity Bill Deliberations
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The Biotechnology Innovation Organization (BIO), a prominent US industry trade group, is conducting a survey among its members to assess the extent of reliance on China-based Contract Development and Manufacturing Organizations (CDMOs), according to a report by FiercePharma.com. The survey, titled “Understanding Key Elements of the Biopharma Supply Chain,” aims…
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US Legislature Reviews BioSecurity Bill to Sever Biotech Industry Ties with Chinese Companies
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On May 15, 2024, the US House Oversight Committee is set to review a “BioSecurity” bill proposal that could have significant implications for the biotechnology industry. The bipartisan-supported bill aims to prohibit companies receiving US government funding from engaging in commercial dealings with certain biotech companies identified as national security…
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WuXi AppTec’s Q1 2024 Revenues Affected by COVID-19 Project Exclusion
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China’s leading Contract Research Organization (CRO), WuXi AppTec (HKG: 2359, SHA: 603259), has announced its financial results for the first quarter of 2024, with revenues reaching RMB 7.98 billion (USD 1.1 billion), marking a slight decrease of 1.8% year-on-year (YOY), excluding COVID-19 commercialization projects. The company’s original customer income stood…
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Bristol-Myers Squibb Prepares Contingency Plans in Response to the Biosecure Act
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Bristol-Myers Squibb (BMS; NYSE: BMY), a leading U.S. pharmaceutical company, is reportedly drafting ‘contingency plans’ to address the potential implications of the Biosecure Act, which is currently under legislative review in the United States. As detailed by the Financial Times, BMS’s CFO, David Elkins, disclosed on a media call that…
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Takeda Exits Biotechnology Innovation Organization as Big Pharma Reevaluates Industry Groups
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Japanese pharmaceutical giant Takeda (NYSE: TAK) has officially withdrawn its membership from the Biotechnology Innovation Organization (BIO), the world’s largest biotech trade association, according to Fierce Pharma. This move makes Takeda the fourth major company to leave BIO since December of the previous year, following the exits of Pfizer and…
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BIO’s Chief Lobbyist Nick Shipley Resigns Amid Controversy Over WuXi AppTec
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Nick Shipley, the chief lobbyist for the U.S.-based Biotechnology Innovation Organization (BIO), has resigned from his position, as first reported by Endpoints News and confirmed by FiercePharma. Shipley, who joined BIO in 2021 as chief advocacy officer, was responsible for the organization’s interactions with federal and state governments. He departed…
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WuXi AppTec Denies US Allegations of Unauthorized Intellectual Property Transfer
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WuXi AppTec (SHA: 603259, HKG: 2359), a leading Contract Research, Development, and Manufacturing Organization (CRDMO) based in China, has found itself at the center of a controversy following allegations by US intelligence officials. According to a Reuters report, these officials claimed that WuXi AppTec had transferred a client’s intellectual property…
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WuXi AppTec Denies Unauthorized IP Transfer Allegations Amidst Strong Financial Performance
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WuXi AppTec (SHA: 603259, HKG: 2359), a China-based Contract Research, Development, and Manufacturing Organization (CRDMO) , faced allegations this week that could potentially impact its international reputation. According to a Reuters report, US intelligence officials have accused the company of transferring a client’s intellectual property to Beijing without authorization. The…
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WuXi XDC Reports 114.4% YOY Revenue Growth in 2023, Driven by ADC CRDMO Business
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WuXi XDC (HKG: 2268), a joint venture between WuXi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), has unveiled its financial performance for 2023, reporting revenues of RMB 2.124 billion, marking a significant increase of 114.4% year-on-year (YOY), primarily driven by its antibody…
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WuXi XDC Breaks Ground on State-of-the-Art Manufacturing Base in Singapore to Boost ADC Production
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WuXi XDC (HKG: 2268), a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), has announced plans to construct a new manufacturing base at the Tuas Biomedical Park in Singapore. This strategic expansion is designed to enhance the joint venture’s…
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WuXi AppTec Posts Modest Revenue Growth Despite Regulatory Hurdles
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WuXi AppTec (HKG: 2359), a China-based Contract Research Organization (CRO), has released its financial results for 2023, reporting an annual operating revenue of RMB 40.34 billion (USD 5.6 billion), representing a year-on-year (YOY) increase of 2.5%. When excluding COVID-19-related commercial projects, sales experienced a substantial growth of 25.6%. The net…
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BIO Reverses Support for WuXi AppTec Amid Security Concerns, Plans Legislative Shift
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The Biotech Innovation Organization (BIO), a US-based industry lobbying group, has reversed its stance on the Chinese Contract Development and Manufacturing Organization (CDMO) WuXi AppTec (SHA: 603259). In a press release from BIO CEO John Crowley, the organization announced it is taking steps to dissociate from WuXi AppTec regarding its…
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US Senate Committee Backs Bill to Restrict Chinese Biotechnology Firms’ Access to American Genetic Data
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The U.S. Senate’s homeland security committee has voted 11-1 in favor of the Prohibiting Foreign Access to American Genetic Information Act of 2024, a bill that seeks to curb the operations of Chinese research service providers, including BGI and WuXi AppTec (SHA: 603259, HKG: 2359), within the U.S. The legislation,…
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WuXi ATU’s Philadelphia Facility Approved for Amtagvi Production Following FDA Nod
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WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec (SHA: 603259, HKG: 2359) based in China, has announced the U.S. FDA’s approval of its Philadelphia facility to commence analytical testing and manufacturing of Amtagvi (lifileucel) for Iovance. This novel therapy received accelerated approval for its Biologics License…
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US Lawmakers Call for Sanctions Against WuXi AppTec and WuXi Biologics Over National Security Concerns
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US politicians have intensified their opposition to China’s biotech industry, with Congressmen and Senators sending a letter to the White House Administration, directly calling for sanctions against WuXi AppTec (SHA: 603259) and its affiliate WuXi Biologics (HKG: 2269). As reported by Reuters, the letter was signed by four lawmakers: Congressmen…
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US Senate Puts Brakes on Bill Targeting China-Based CDMOs Amid Stock Market Reactions
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A US Congress bill aimed at prohibiting US-funded entities from engaging with various China-based contract development and manufacturing organizations (CDMOs) has reportedly been sidelined by the Senate this week. The bipartisan legislation, which previously triggered a significant decline in stock prices for companies like WuXi AppTec (HKG: 2359, SHA: 603259),…
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WuXi XDC Forecasts Over 100% Revenue Growth for 2023 on Strength of ADC Industry
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WuXi XDC (HKG: 2268), a joint venture between Wuxi Biologics (HKEX: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), has unveiled an impressive 2023 performance forecast following its recent listing on the Hong Kong stock exchange. The company anticipates a more than 100% surge in…
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WuXi XDC Partners with Multitude Therapeutics and Signs MOU with Shanghai Huilian to Advance ADC Technologies
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WuXi XDC (HKG: 2268), a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), has entered into a strategic partnership with Shanghai-based antibody drug conjugate (ADC) specialist, Multitude Therapeutics. Additionally, WuXi XDC has signed a memorandum of understanding (MOU) with…
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China-Based Biotechs Respond to US House Bill Limiting Federal Funding for ‘Concerning’ Companies
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A bipartisan bill introduced on January 26, 2024, by members of the US House Select Committee on strategic competition between the US and China has caused a significant decline in the share prices of various China-based biotech and contract development organizations (CDOs) last week. The companies have begun to respond…
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WuXi XDC Partners with Celltrion to Support Global Development and Manufacturing of Bioconjugated Drugs
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WuXi XDC (HKG: 2268), a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), has announced a cooperation memorandum of understanding (MOU) with South Korean firm Celltrion Inc. (KRX: 068270) to provide comprehensive services for the development and manufacturing of…
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WuXi AppTec Expands Peptide Manufacturing Capacity with Two New Plants in China
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WuXi AppTec (HKG: 2359, SHA: 603259), a leading China-based Contract Research, Development, and Manufacturing Organization (CRDMO), has announced the commissioning of two new peptide manufacturing plants. One plant is located at its existing facility in Changzhou, and the other is a new site in Taixing. This expansion adds 32,000 liters…
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WuXi XDC Aims for HKEX Listing with IPO of 178.4 Million Shares
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WuXi XDC (HKG: 2268), a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), is preparing for an initial public offering (IPO) on the Hong Kong Stock Exchange. The company plans to issue 178.4 million shares, priced between HKD 19.9…
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Ji Xing Pharmaceuticals Partners with WuXi STA for Sterile Nasal Spray Production
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Shanghai-based Ji Xing Pharmaceuticals, backed by RTW Investments, has formed a strategic partnership with WuXi STA, a subsidiary of WuXi AppTec (HKG: 2359, SHA: 603259), to establish a sterile nasal spray production line. This collaboration aims to leverage the strengths of both companies, with the new production facility set to…
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WuXi XDC Partners with Hong Kong Science Park to Boost CRDMO Value Chain
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WuXi XDC, a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), has entered into a strategic cooperation framework agreement with Hong Kong Science and Technology Parks Corp. The partnership aims to promote the establishment of a Contract Research, Development,…
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WuXi XDC Expands Manufacturing Capacity with New GMP Facilities in Wuxi
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WuXi XDC (HKG: 2268), a joint venture between Wuxi Biologics (HKG: 2269) and WuXi STA, a subsidiary of WuXi AppTec Co., Ltd (SHA: 603259), has announced the commencement of GMP manufacturing at its state-of-the-art commercialization facilities, XBCM2 and XDP2, located in Wuxi. This development is anticipated to double the company’s…
