SHANGHAI, June 15, 2024 /PRNewswire/ — CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the initial results from the ongoing first-in-human study of CT071 have been presented at the 29th Annual Congress of the European Hematology Association (EHA).

The preliminary results of Phase I of CT071 (NCT05838131) were presented as a poster at the 29th EHA Annual Congress on June 14, 18:00 – 19:00 CEST, which was titled “First-in-human study of GPRC5D-targeted CAR T cells (CT071) with an accelerated manufacturing process in patients with relapsed/ refractory multiple myeloma (RRMM)”.^[1]

“Multiple myeloma is a common yet incurable hematologic malignancy with high unmet need. Despite the numerous recent advances, most patients relapse and become refractory to available therapies and therefore, novel therapies are needed. GPRC5D, a protein highly expressed on the surface of malignant plasma cells with limited expression on normal tissues, represents a promising target for treating multiple myeloma. CT071 is a fully human GPRC5D-targeting autologous second-generation CAR T-cell product manufactured using our expedited CARcelerate^TM platform that shortens the manufacturing time to around 30 hours, supporting a shorter vein-to-vein time and younger T cells. The preliminary results of the ongoing study presented at EHA shows that CT071 has the potential to be the best-in-class GPRC5D targeting CAR-T therapy,” said Raffaele Baffa, M.D., Ph.D., Chief Medical Officer of CARsgen Therapeutics. “We are excited about advancing CT071 and look forward to sharing future updates with the medical community.”

As of February 28, 2024, 10 patients were dosed with CT071—7 patients at 1.0×10⁵ cells/kg and 3 patients at 3.0×10⁵ cells/kg. Among them, 80% had high-risk cytogenetics, 30% had one or more extramedullary plasmacytomas (EMD), and 40% were at R-ISS stage III. This was a heavily pre-treated population with a median of 5 prior lines of therapy, including 90% double-class refractory, 70% triple-class refractory, 40% penta-drug refractory, 50% having received autologous stem cell transplantation, and 20% had previously been treated with BCMA/CD19 dual-targeting CAR T cells. None of the patients on the study required bridging therapy due to rapid manufacturing turnaround.

The median follow-up at the time of data cut-off was 4.07 months (range: 2.8-7.4). There were no Grade 3 or higher cytokine release syndrome (CRS) events. No immune effector cell-associated neurotoxicity syndrome (ICANS) was observed. No adverse events of special interest or dose limiting toxicity (DLT) occurred. Four patients experienced treatment-related SAE, including pneumonia (n=1), decreased appetite (n=1) and thrombocytopenia (n=2), and all recovered.

The overall response rate was 90%, including 5 patients (50%) with stringent complete response (sCR), 2 patients (20%) with very good partial response (VGPR), and 2 patients (20%) with partial response (PR). All the 9 patients with evaluable MRD assessment at Week 4 achieved MRD negativity (10^-6 threshold) ), including all 5 patients with sCR/CR. The pharmacokinetic analysis demonstrated robust cell expansion and persistence, with median T_max of 14 days (range: 12-28) and median C_max of 32280.5 copies/μg gDNA (range: 8372-106060).

About CT071
CT071 is a CAR T-cell therapy candidate developed utilizing CARsgen’s proprietary CARcelerate^TM platform targeting GPRC5D for the treatment of R/R MM or relapsed/refractory plasma cell leukemia (“R/R PCL”). An investigator-initiated trial (NCT05838131) is ongoing in China to evaluate the safety and efficacy of CT071 for the treatment of R/R MM or R/R PCL. Another investigator-initiated trial (NCT06407947) is ongoing in China for the treatment of newly diagnosed multiple myeloma (NDMM).

About CARsgen Therapeutics Holdings Limited
CARsgen is a biopharmaceutical company with operations in China and the U.S. and is focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has established a comprehensive CAR T-cell research and development platform, encompassing target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. CARsgen has internally developed novel technologies and a product pipeline with global rights to address major challenges of CAR T-cell therapies, such as improving the safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. CARsgen’s mission is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable.

Forward-looking Statements
All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group’s current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group’s control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading “Principal Risks and Uncertainties” in our most recent annual report and interim report and other announcements and reports made available on our corporate website, https://www.carsgen.com. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release.

Reference
[1] J Du, et al. EHA 2024. 2024 Jun; Poster P941

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HAIKOU, China, June 15, 2024 /PRNewswire/ — A report from Hainan International Media Center:

Recently, a delegation from China’s southern Hainan Province visited South Korea and the United States for economic, trade and cultural exchange activities. By promoting the policies of the Hainan Free Trade Port (FTP) and displaying the high-quality development results, Hainan has deepened economic, trade, tourism, and cultural ties with the two countries, signing agreements related to cultural tourism, medical & healthcare services, green and low carbon development, high-end consumption, new technology, and financial investment.

Attending the 19th Jeju Forum and the 9th Trilateral Summit Meeting among China, Japan and the Republic of Korea, delegation members from the Hainan Provincial Department of Tourism, Culture, Radio, Television, and Sports signed a “Memorandum of Understanding on Jointly Promoting Workation Projects” with the Jeju Tourism Exchange Bureau to further strengthen the island province’s tourism cooperation with Jeju, promote tourism standards, customer source sharing and mutual delivery, and joint marketing of tourism products. A series of activities will be held next year to celebrate the 30th anniversary of the sister province relationship between Hainan and Jeju.

During their time in the US, the delegation attended the California-Hainan High-Level Climate Dialogue, a signing ceremony for the Philadelphia Orchestra’s 2024 China Cultural Exchange Tour, and other activities. They also met with various parties to implement cooperation projects such as sister city visits, direct flights, climate change response, clean energy, agricultural technology, education, and medical tourism.

Additionally, the delegation attended special seminars or industry matchmaking meetings held by friendly groups, including the U.S. Business Council for International Understanding, PAX sapiens, the National Committee on U.S.-China Relations, and the Chinese Chamber of Commerce of Hawaii.

In recent years—with the development of Hainan FTP as China’s only and the world’s largest free trade port—changes to the island province have been gaining momentum, with rapid improvement in various economic and social aspects. For example, in 2023, Hainan’s GDP grew by 9.2%, trade in goods and trade in services by 15.3% and 29.6%, and overseas direct investment by 104.9%.

As per the introduction of the development status and prospects of the Hainan FTP made at the “Hainan Free Trade Port Promotion Event” held in Seoul, South Korea on May 31, Hainan is remarked as OPEN  (“Outgoing”, “Progressive”, “Energetic”, and “Noteworthy”).

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ZHOUSHAN, China, June 14, 2024 /PRNewswire/ — This summer, the 4th Zhejiang Ocean Games were grandly held on the picturesque island of Shengsi, attracting over 7,000 marine sports enthusiasts from across the country. Spanning from May to June, this month-long competition has significantly boosted attention towards Zhejiang’s burgeoning marine economy and island tourism.

On May 18th, the Ocean Games kicked off with a spectacular opening ceremony themed “Sailing to the Sea.” The event seamlessly blended sports, tourism, and island leisure, offering participants not only the thrill of marine sports, but also a deep dive into the local marine culture.

The competition featured 15 diverse events focusing on the beach, island circuit as well as the sea itself, including cycling, trail walking, beach volleyball/soccer/tug of war/frisbee, sailing, sea fishing, surfing, paddle boarding and open water swimming.

This year, the Games fully leveraged Shengsi’s abundant marine resources, introducing new Olympic sports such as kiteboarding and coastal rowing sprints. These additions aligned the event more closely with international standards. Furthermore, as a comprehensive ocean sports event combining competitive sports with national fitness activities, the organizing committee included accessible and entertaining events like beach volleyball, island trail walking, and paddle boarding. Also included, as a demonstration event, was the Olympic Sport of kite surfing with their kites providing a colourful backdrop to the marvellous opening ceremony.

Zhoushan, the host venue, is home to Ningbo-Zhoushan Port, the largest port in the Far East and the world’s leading port for cargo throughput for 14 consecutive years. Positioned at the nexus of the Silk Road Economic Belt and the 21st Century Maritime Silk Road, it connects over 600 ports across the world in more than 190 countries and regions. Hosting the Ocean Games in Zhoushan, a major comprehensive sports event in Zhejiang Province, highlights the integration of marine sports with island resources. This fusion of culture, tourism, and sports not only offers a new business model for Shengsi’s marine economy but also sets a precedent for Zhejiang Province in exploring the transformation and upgrading of its marine industry.

Under the sunshine and gentle sea breeze, competing on a picturesque beach is a pleasant and wonderful experience, remarked one participant, who brought the family to Shengsi for a unique island vacation.

The 4th Zhejiang Ocean Games have successfully showcased the charm of Zhejiang’s marine culture, promoting a vibrant marine economy and positioning Shengsi as a premier destination for marine sports and tourism while providing a glimpse of the archipelago’s potential as a sports and leisure Mecca.

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SHENZHEN, China, June 15, 2024 /PRNewswire/ — The UEFA European Football Championship 2024 (UEFA EURO 2024™) opened on June 14, 2024, at the Munich Football Arena in Germany, amidst the anticipation of fans worldwide. As one of the most watched football tournaments globally, it brings together top teams from across Europe and attracts millions of football lover around the world. vivo again returns to the international football arena as the official partner of the UEFA EURO 2024™ following the 2022 FIFA World Cup.

vivo aims to enhance the spectator experience at UEFA EURO 2024™ by leveraging its industry-leading technologies, latest flagship portrait products, and rich experience in international sporting event collaborations. As the official partner of the UEFA EURO 2024™, vivo V30 series will showcase its advanced imaging capabilities, allowing users to capture professional-quality portraits and exciting moments both on and off the field. 

vivo V30 series: Capture WOW moments on the field with studio-level portrait photography

The new vivo V30 series elevates portrait photography with the latest Aura Light Portrait, while delivering smooth performance, a bright display, and long battery life. Empowered by its exclusive technology, the soft light can intelligently calibrate its color temperature base on ambient environmental hues and modulates its brightness according to proximity. This innovation harmonises color tones with the surrounding environment, ensuring the creation of stunning portraits even in challenging lighting conditions.

The vivo V30 Pro stands out within the V30 series as the first V series smartphone equipped with the vivo ZEISS Co-Engineered Imaging System, taking mobile portrait photography to a new level. It features a 50 MP Professional Portrait Camera with a 50 mm focal length that authentically reproduces what the human eye sees, minimizing distortion and magnifying the emotions captured in every shot. This is especially important for football fans, who can now capture the intense emotions of the players and the vibrant atmosphere of the crowd in vivid, detailed images with stunning clarity. 

With a remarkable 119° field of view^[1], the 50 MP AF Ultra Wide-Angle Camera, is meticulously designed to capture expansive stadium scenes and large group photos with unparalleled precision. Its advanced capabilities transcend the boundaries of ordinary photography, making no moment too big to capture. Perfect for documenting the sweeping landscapes of cheering fans and the grand spectacle of thrilling action at the UEFA EURO 2024™, this camera is the epitome of visual storytelling.

The introduction of ZEISS Style Portrait to the vivo V30 Pro provides six distinct portrait style options, including the iconic ZEISS Biotar, Sonnar, Planar, Distagon, Cinematic Style Bokeh and ZEISS Cine-Flare Portrait, so fans can add artistic flair characteristics to their images to truly capture the spirit and emotion of the UEFA EURO 2024™. The ZEISS Border Watermark allows fans to add a professional touch to their images, perfect for sharing on social media and showcasing their personal experiences. These features, combined with the flexibility to adapt ZEISS Natural Color or other vivo color profiles, make the vivo V30 Pro a powerful tool for fans to record and share their unique football journey, capturing every goal, cheer, and moment of celebration in exceptional detail.

The Synergy of Sport and Technology: Sharing the Joy of Humanity

The UEFA EURO 2024™ is not only a globally recognized sporting event, but also a bridge for vivo to convey its “The Joy of Humanity” brand message to the global audience and connect with football fans around the world.

vivo has always been committed to delivering the authentic spirit of humanity and sport to global fans and audiences. As a leading smartphone brand, vivo keeps pushing the boundaries of mobile imaging through continuous research and innovation, strategic partnerships, and product development. With the unparalleled imaging capabilities of the vivo V30 series, football lovers and photographers will bring more possibilities for effortlessly capturing the beauty of sports at the UEFA EURO 2024™.

“Our partnership with UEFA EURO 2024™ allows us to enhance the user experience by enabling everyone to enjoy the beautiful game and capture their most cherished memories,” said Yongduan Zhou, General Manager of the Overseas Product Department. “The exciting game brings people all around the world together, and with V30 Pro, we want to fuel that passion by enabling users to become storytellers of this unforgettable journey. We’ll continue to develop the cutting-edge technologies that advance mobile photography and ensure that everyone can be a storyteller of their own experiences, with one single tap.”

About vivo

vivo is a technology company that creates great products based on a design-driven value, with smart devices and intelligent services as its core. The company aims to build a bridge between humans and the digital world. Through unique creativity, vivo provides users with an increasingly convenient mobile and digital life. Following the company’s core values, which include Benfen,* user-orientation, design-driven value, continuous learning and team spirit, vivo has implemented a sustainable development strategy with the vision of developing into a healthier, more sustainable world-class corporation.

While bringing together and developing the best local talents to deliver excellence, vivo is supported by a network of R&D centers in Shenzhen, Dongguan, Nanjing, Beijing, Hangzhou, Shanghai, and Xi’an, focusing on the development of state-of-the-art consumer technologies, including 5G, artificial intelligence, industrial design, imaging system and other up-and-coming technologies. vivo has also set up an intelligent manufacturing network (including those authorized by vivo), with an annual production capacity of nearly 200 million smartphones. As of now, vivo has branched out its sales network across more than 60 countries and regions, and is loved by more than 400 million users worldwide.

*”Benfen” is a term describing the attitude on doing the right things and doing things right – which is the ideal description of vivo’s mission to create value for society.

Stay informed of latest vivo news at https://www.vivo.com/en/about-vivo/news   

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• Ascentage Pharma has executed an Exclusive Option to License Global Rights to Olverembatinib worldwide other than China and a few other areas.
• Ascentage Pharma to receive an option payment of 100 million USD upon closing and be eligible for an option exercise fee and additional potential milestones of up to approximately 1.2 billion USD, and double-digit royalties on annual sales
• Additionally, Takeda will purchase a minority interest in Ascentage Pharma

ROCKVILLE, Md. and SUZHOU, China, June 14, 2024 /PRNewswire/ — Ascentage Pharma (6855 HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today the signing of an option agreement with Takeda to enter into an exclusive license agreement for olverembatinib, an oral, potentially best-in-class third-generation BCR-ABL tyrosine kinase inhibitor (TKI), which is currently in development for chronic myeloid leukemia (CML) and other hematological cancers. If exercised, the option would allow Takeda to license exclusive global rights to develop and commercialize olverembatinib in all territories outside of among others, mainland China, Hong Kong, Macau, Taiwan, China.

Despite the impact TKIs have had in the treatment of patients with CML, there remains a significant unmet need for patients whose disease is resistant to these therapies or who develop hard-to-treat mutations following these treatments.

Under the terms of this option agreement, Ascentage Pharma is set to receive 100 million USD from Takeda to acquire the option to license olverembatinib. Ascentage will also be eligible for an option exercise fee and additional potential milestones of up to approximately 1.2 billion USD. Additionally, Ascentage Pharma is expected to receive a minority equity investment from Takeda.

As part of the agreement, Ascentage Pharma will continue to be solely responsible for all clinical development of olverembatinib before the potential exercise of the option to license olverembatinib. Olverembatinib is currently approved and marketed in China for the treatment of adult patients with TKI-resistant chronic-phase CML (CP-CML) or accelerated-phase CML (AP-CML) harboring the T315I mutation, and in adult patients with CP-CML resistant to and/or intolerant of first-and second-generation TKIs.

“We are thrilled to enter into this agreement with Takeda, which would allow us to leverage the global commercial expertise of an organization with a proven track record and global oncology footprint to potentially broaden the impact olverembatinib could have on patients in need around the world,” said Dr. Dajun Yang, Chairman and CEO of Ascentage Pharma. “Olverembatinib has already had a significant impact for patients with CML in China. We are excited to further the development of olverembatinib in our ongoing global registrational Phase 3 studies.”

“Throughout our history in oncology, Takeda has demonstrated a strong track record of working with companies that share our vision of bringing medicines to patients around the world with the highest unmet needs,” said Teresa Bitetti, president of Takeda’s Global Oncology Business Unit. “Through this agreement with Ascentage Pharma, we believe there is great potential to continue to advance this mission. We are highly encouraged by the promising results olverembatinib has shown in the clinic to date, and excited to have the opportunity to further develop and deliver it to patients with chronic myeloid leukemia and other hematological cancers.”

About Olverembatinib

Olverembatinib, the company’s core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company’s first approved product, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug has been included in the China 2022 National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU.

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK. Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of 9 clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, Europe, and China. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five Major New Drug Projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases. To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company’s investigational drug candidates.

Investors Contacts: IR@ascentage.com
Media Contacts: PR@ ascentage.com

Forward-Looking Statements

The forward-looking statements in this article relate only to the events or information as of the date on which the statements are made. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

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