CSPC Holdings Co., Ltd.

SYS6057, a recombinant respiratory syncytial virus (RSV) vaccine candidate developed by CSPC Pharmaceutical Group (HKEX: 01093), has received FDA clearance to begin clinical trials in the US, less than a month after China's National Medical Products Administration (NMPA) granted the same authorization on 30 July 2026. The back-to-back regulatory clearances give the Hong Kong-listed company a simultaneous development path in two of the world's largest markets for RSV prophylaxis in older adults. SYS6057 combines the RSV prefusion F (Pre-F) protein antigen with a proprietary second-generation nano-adjuvant system. CSPC says the adjuvant uses a different nanocarrier compared with its earlier RSV vaccine candidate, conferring distinct physicochemical and immunological properties. Preclinical data, according to the company, showed the vaccine can simultaneously elicit high-titre neutralising antibodies and cellular immune responses — a dual-arm immune profile the company attributes to adjuvant optimization. No clinical efficacy or safety data have been disclosed. The planned clinical development in both countries targets prevention of RSV-associated lower respiratory tract disease in adults aged 60 and older. Trial design, participant numbers, dosing, and primary endpoints have not been disclosed. CSPC enters a market where three RSV vaccines are already approved in the US for older adults: GSK's Arexvy (RSVPreF3-AS01E), Pfizer's Abrysvo (RSVpreF), and Moderna's mRESVIA (mRNA-1345), first approved in May 2023, May 2023, and May 2024, respectively. Arexvy and Abrysvo use prefusion F protein antigens, while mRESVIA uses mRNA encoding the prefusion F protein. SYS6057 similarly targets prefusion F but combines the recombinant antigen with CSPC's proprietary nano-adjuvant system, broadly resembling Arexvy's protein-plus-adjuvant strategy while using different adjuvant technology. CSPC describes SYS6057 as its second recombinant protein vaccine candidate to enter clinical trials. Spot something wrong? Report an issue with this article

Shijiazhuang, China/ iStock, Govan Zhang News of the joint venture comes months after AstraZeneca vowed to spend $15 billion in China by the end of the decade. AstraZeneca and CSPC Pharmaceutical have formed a joint venture to build a biologics manufacturing plant in China. The new deal adds to multiple deals already struck between the two companies and is part of AstraZeneca’s broader, long-running interest in China. In January, the drugmaker committed to spending $15 billion in the country by the end of the decade. Under the terms of the new collaboration, CSPC and AstraZeneca will contribute capital at an equity ratio of 51% and 49%, respectively, to finance construction of the site in Shijiazhuang, China. The city, which is 165 miles southwest of Beijing, is home to CSPC’s headquarters. ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); CSPC and AstraZeneca will jointly manage the site’s construction and day-to-day operations, leveraging their respective expertise. AstraZeneca is bringing its global quality system and supply management experience to the project, while CSPC highlighted its experience in building “highly automated, intelligent and lean manufacturing facilities.” The partners will focus initially on manufacturing and supplying mutually agreed, undisclosed biologic drug substances for global markets. CSPC and AstraZeneca plan to explore adding more products to the facility’s scope of operations as the business develops, production capacity scales up and commercial demand grows. Working with AstraZeneca will support the creation of high-quality manufacturing capabilities that meet the demands of the international market, CSPC said. The Chinese drugmaker framed the partnership as a way to enhance its ability to serve global markets and lay the foundations for launching more products overseas. The partnership adds another element to AstraZeneca’s multifaceted relationship with CSPC. In 2024, the Anglo-Swedish drugmaker paid CSPC $100 million upfront for rights to a preclinical lipid-lowering drug candidate. Since then, AstraZeneca has returned to CSPC repeatedly to build out its R&D pipeline. Having paid CSPC $110 million to form an AI drug development pact in 2025, AstraZeneca has upped the pace in 2026 by paying $1.2 billion upfront for a GLP-1/GIP prospect and handing over $30 million to start collaborating on kidney diseases. Beyond R&D, AstraZeneca is turning to China to up its manufacturing presence. In addition to funding to the new CSPC-partnered facility, part of AstraZeneca’s promised $15 billion investment in China will go toward developing its existing production plants in China, including those in Wuxi, Taizhou and Beijing. AstraZeneca also bolstered its manufacturing presence in Beijing last year through an alliance with BioKangtai to set up its first vaccine manufacturing facility in the country. Months later, AstraZeneca outlined plans to invest an additional $136 million in a plant in Qingdao that makes inhaled medicines. Moreover, AstraZeneca in March shared details of a cell therapy manufacturing center it is building in Shanghai. The facility is intended to establish AstraZeneca as the first Western drugmaker with end-to-end cell therapy capabilities in China.

Takeda's first-in-class orexin treatment won an FDA nod in narcolepsy. Daiichi Sankyo faced investor pushback after admitting to an accounting error. Astellas booked a new quarterly revenue record. And more. 1. Takeda gains FDA nod for first-in-class narcolepsy treatment Orzeyful Takeda’s Orzeyful (oveporexton) has become the first orexin treatment to reach the market. Approved by the FDA for narcolepsy type 1, the drug is also the first medicine to address the root cause of the disease, rather than its symptoms. Takeda has pegged Orzeyful’s peak sales at between $2 billion and $3 billion. 2. Daiichi Sankyo flags accounting error, as shares tank despite revenue beat Daiichi Sankyo’s stock price tanked 11% after the company reported $182 million in extra expenses that it had missed in its fiscal year 2025 report. The Japanese pharma attributed the incident to “booking errors in accounts payable for suppliers.” Meanwhile, despite major antibody-drug conjugate sales growth, questions remain around the firm’s profitability. 3. Astellas’ revenue hits new record as strategic brands drive major beat (release, PDF) Astellas’ quarterly revenue hit a new high. At 640.9 billion Japanese yen ($4.05 billion) for the three months ended in June, it marked 26.7% growth year over year, crushing analysts’ consensus by 15%. Sales from key brands, including Pfizer-partnered Padcev, eye drug Izervay, stomach cancer therapy Vyloy and menopause med Veozah, all topped expectations. 4. AstraZeneca, CSPC to form joint venture for biologics manufacturing AstraZeneca has teamed up with CSPC Pharmaceutical again, this time on a new manufacturing joint venture in China. The new 51-49 joint venture, located in Shijiazhuang, will initially focus on producing “mutually agreed biologics drug substances for the global markets,” CSPC said. The two firms have multiple ongoing R&D collaborations. 5. From Abu Dhabi to Brazil, every region is vying for the ‘new emerging economy’ of biotech Asian countries are vying to build out their own biopharma ecosystems. “South Korea stands out as a reliable and fully compliant alternative that offers operational continuity without regulatory friction,” James Choi, chief marketing officer at Samsung Biologics, told Fierce. 6. In a first, Otsuka’s Voyxact stabilizes IgAN patients’ kidney function decline to normal levels Otsuka’s Voyxact has become the first drug to stabilize kidney function decline to the normal rate in a phase 3 trial among patients with IgA nephropathy. Results from the phase 3 Visionary trial linked Voyxact to an annualized estimated glomerular filtration rate (eGFR) slope of a 0.3 mL/min/1.73m² gain over two years, versus a 4.2 mL/min/1.73m² decline for placebo. 7. Once again, child dies in gene-editing trial in China, rekindling debate on transparency and safety (Stat) 8. Braveheart charges past expectations with $382.5M IPO to fund cardio drug from Hengrui 9. Sanofi-backed Expedition uses $115M series B to advance COPD drug on phase 2 journey 10. Shionogi makes the call on COVID pill Xocova TV spot 11. Ono, Mediar enter antibody discovery pact for fibro-inflammatory diseases (release)