Acalabrutinib

AstraZeneca is further increasing the Qingdao site’s production capacity of inhaled aerosols. The move is designed to help the drugmaker better meet the needs of patients with respiratory diseases such as asthma and COPD. AstraZeneca is pouring $136 million more into the expansion of an inhalants production base in China.The latest investment brings the British pharma’s total investment at the site in Qingdao to $886 million. AstraZeneca unveiled (Chinese) the outlay Wednesday at the China International Import Expo (CIIE), an annual event where foreign companies parade their commitments to the country. The announcement also follows days of drug pricing negotiations between manufacturers and the Chinese government to hash out coverage under China’s national insurance scheme. AZ’s injectable biologic drug for asthma, Fasenra, along with cancer therapies Truqap and Calquence, are among those vying for a spot on China's National Reimbursement Drug List.Last year, AZ’s partner Daiichi Sankyo made a $152 million commitment to build an antibody-drug conjugate (ADC) manufacturing facility in Shanghai, just as the two firms’ HER2-directed ADC Enhertu was added to national coverage.AZ first unveiled its plan to build the Qingdao facility in 2022, with a $450 million investment deal signed with the local government the following March. At that time, the project was billed as a capacity expansion for AZ’s chronic obstructive pulmonary disease (COPD) inhaler Breztri Aerosphere.The British pharma has since repeatedly amped up investments in the site, first with $250 million in August 2023 to increase filling capacity and add new packaging lines, followed by another $50 million last August. By then, the facility was said to have the capacity to make 54 million doses of respiratory medications annually, with AZ predicting the site would come online in 2028. The latest funds will further beef up the site’s production capacity of inhaled aerosols to meet the needs of patients with respiratory diseases such as asthma and COPD, AZ said in a Nov. 5 release.In parallel, AZ has been executing a $475 million plan to build a small-molecule factory in Wuxi, China—a project that was first unveiled at the 2023 CIIE event.Entering this year, AZ in March outlined a global R&D center in Beijing as part of a $2.5 billion investment in the city. The total amount also covers partnerships with local biotechs, a manufacturing plant in China’s capital, and additional hires. The Beijing R&D center, which is AZ’s sixth globally, is now operational, the company said on Oct. 25.The R&D move came as Chinese authorities launched a probe into illegal drug importation at AZ’s local operations. Several AZ employees, including then China head Leon Wang, were implicated in the investigation. AZ has since shuffled its Chinese organization, installing Iskra Reic, Ph.D., as the new EVP of international overseeing the Chinese business, among other markets. “AstraZeneca remains committed to deepening its presence in China and working hand in hand with partners to help China become a key hub for global healthcare innovation,” Reic said in a Chinese statement on the new investment. “The expansion of our Qingdao facility announced at the CIIE reflects our confidence in China’s innovation ecosystem and our vision to work together to promote scientific progress for the common health.”AZ has emerged from the importation scandal largely unscathed. In February, the company said it could face a fine of up to $4.5 million over illegal imports of cancer drugs Imfinzi and Imjudo. Then, in April, AZ said penalties related to illegal imports of Enhertu could reach $8 million.In the first half of the year, AZ reported 5% revenue growth in China at constant currencies, reaching $3.5 billion for the period, thanks in part to strong performance from Breztri. The company will report third-quarter earnings Thursday.

Lund, Sweden – November 3, 2025 – BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, today announced that it will present new data from the safety run-in portion of its ongoing trial evaluating BI-1206 in combination with rituximab and Calquence® (acalabrutinib) for the treatment of non-Hodgkin's lymphoma (NHL) in a poster at the upcoming 2025 American Society of Hematology (ASH) Annual Meeting, taking place December 6-9, 2025, in Orlando, Florida. Abstract data (as of August 4, 2025) published in the November supplemental issue of Blood demonstrates that the triple combination regimen is safe and well-tolerated, with encouraging efficacy data. Due to the current number of patients, it is important to note that the response rates are still fluctuating, and the data set will become more robust as patient numbers increase. A more recent data set will be included in the poster at ASH to be presented on December 8, 2025. “We are very pleased with the progress of the trial and encouraged by both the safety and efficacy signals emerging from the safety run-in. We are delighted that ASH has accepted our data for a poster presentation” said Martin Welschof, Chief Executive Officer of BioInvent. “The data show that the triple combination is well-tolerated and the overall response rate is well on track to meet our goals. This would provide a strong foundation for advancing into the next phase, where we look forward to further evaluating the potential of this regimen to transform outcomes for patients and improve the standard of care.” Poster presentation details: Title: Promising efficacy of BI-1206, an antibody targeting FcγRIIB in combination with rituximab and acalabrutinib in R/R NHL patientsDate and Time: December 8, 2025, 6:00 PM - 8:00 PM ETSession name: 623. Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster IIILead Author: Laura Fogliatto, Hospital de Clínicas de Porto Alegre, Porto Alegre, BrazilPublication Number: 5349About the Phase 2a StudyThe triple combination arm in the ongoing Phase 2a study (NCT03571568) combines the subcutaneous formulation of BI-1206 and rituximab with Calquence® (acalabrutinib) in subjects with indolent B-cell non-Hodgkin's lymphoma (NHL) who have relapsed or are refractory to rituximab. Approximately 30 patients are expected to be enrolled in Spain, Germany, USA, and Brazil. In February 2024, BioInvent signed a clinical supply agreement with AstraZeneca (LSE/STO/Nasdaq: AZN) to provide Calquence® for the combination arm. About BI-1206FcγRIIB is overexpressed in several forms of NHL and overexpression has been associated with poor prognosis in difficult-to-treat forms of NHL, such as mantle cell lymphoma. By blocking the receptor FcγRIIB on tumor cells, BI-1206 is expected to recover and enhance the activity of rituximab and acalabrutinib in the treatment of several forms of NHL. The drug candidate is evaluated in two separate clinical Phase 1/2a programs, one for the treatment of solid tumors and one for the treatment of non-Hodgkin's lymphoma (NHL, a type of blood cancer). Both programs show encouraging clinical activity along with good tolerability. About BioInventBioInvent International AB (Nasdaq Stockholm: BINV) is a clinical-stage biotech company that discovers and develops novel and first-in-class immuno-modulatory antibodies for cancer therapy, with ongoing clinical programs in Phase 1/2 trials for the treatment of hematological cancer and solid tumors. The Company's validated, proprietary F.I.R.S.T™ technology platform identifies both targets and the antibodies that bind to them, generating many promising new immune-modulatory candidates to fuel the Company's own clinical development pipeline and providing licensing and partnering opportunities. The Company generates revenues from research collaborations and license agreements with multiple top-tier pharmaceutical companies, as well as from producing antibodies for third parties in the Company's fully integrated manufacturing unit. More information is available at www.bioinvent.com. For further information, please contact:Cecilia Hofvander, VP Investor RelationsPhone: +46 (0)46 286 85 50Email: cecilia.hofvander@bioinvent.com BioInvent International AB (publ)Co. Reg. No.: 556537-7263Visiting address: Ideongatan 1Mailing address: 223 70 LUNDPhone: +46 (0)46 286 85 50www.bioinvent.com The press release contains statements about the future, consisting of subjective assumptions and forecasts for future scenarios. Predictions for the future only apply as the date they are made and are, by their very nature, in the same way as research and development work in the biotech segment, associated with risk and uncertainty. With this in mind, the actual outcome may deviate significantly from the scenarios described in this press release.