On March 21, 2025 OS Therapies (NYSE-A: OSTX) ("OS Therapies" or "the Company"), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, reported that Paul Romness, CEO, and Gerald Commissiong, CBO will be accepting meetings with registered investors at The Jones Healthcare and Technology Innovation Conference (Press release, OS Therapies, MAR 21, 2025, View Source [SID1234651351]). The conference is being held on April 8-9, 2025 at the Venetian Resort in Las Vegas. The Company’s participation aligns with its prioritization of advancements in healthcare and technology while connecting with other investors.

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Event: Jones Healthcare and Technology Innovation Conference

Date: April 8-9, 2025

The conference is hosted by JonesTrading Institutional Services, LLC, a leading full-service investment banking firm providing a comprehensive suite of services, including capital markets, M&A, and strategic advisory to corporate clients. The event aims to bring together leading healthcare and technology companies, institutional investors, and opinion leaders to explore the latest trends and innovations shaping both industries. The conference will offer expert-led panels, corporate presentations, fireside chats, and one-on-one meetings covering advancements in healthcare and technology.

On March 21, 2025 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the year ended December 31, 2024 (Press release, Soligenix, MAR 21, 2025, View Source [SID1234651346]).

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"We remain highly focused on advancing our multiple clinical programs as we work towards achieving a number of important and potentially transformational development milestones, including top-line results in 2026 for our actively enrolling confirmatory Phase 3 placebo-controlled study evaluating HyBryte (synthetic hypericin) in the treatment of early-stage cutaneous T-cell lymphoma (CTCL)," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. In the second half of this year, we also anticipate reporting top-line results from our ongoing Phase 2 studies for SGX945 (dusquetide) in Behçet’s disease and SGX302 (synthetic hypericin) in mild-to-moderate psoriasis."

Dr. Schaber continued, "With approximately $7.8 million in cash at December 31, 2024, we are committed to disciplined resource allocation to achieve our strategic goals. While this cash balance provides operating runway through 2025, we continue to evaluate all strategic options, including partnership, merger and acquisition, government grants, and potential financing opportunities to advance our late-stage pipeline and the Company."

Soligenix Recent Accomplishments

On January 14, 2025, the Company reported positive outcomes observed from the interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte treatment for up to 12 months in patients with early-stage CTCL. To view this press release, please click here.
On December 16, 2024, the Company announced that it had opened patient enrollment for its confirmatory Phase 3 study evaluating HyBryte in the treatment of CTCL. To view this press release, please click here.
On December 2, 2024, the Company announced analysis of the post-treatment data from the open-label study (protocol HPN-CTCL-04) comparing HyBryte to Valchlor (mechlorethamine) demonstrating continued improvement in HyBryte treated patients and their individual lesions even after stopping treatment. To view this press release, please click here.
On November 19, 2024, the Company announced the formation of a European Medical Advisory Board (MAB) to provide additional medical/clinical strategic guidance to the Company as it advances its confirmatory Phase 3 multicenter, double-blind, placebo-controlled study evaluating the safety and efficacy of HyBryte in the treatment of CTCL patients with early-stage disease. To view this press release, please click here.
On November 14, 2024, the Company announced it had opened patient enrollment for its Phase 2 study (protocol number DUS-AUBD-01) evaluating SGX945 (dusquetide) in the treatment of Behçet’s Disease. To view this press release, please click here.
Financial Results – Quarter Ended December 31, 2024

Soligenix reported revenues of $0.1 million for the year ended December 31, 2024, compared to $0.8 million for the prior year. The decrease was primarily due to the timing of government grant funding and contracts supporting the development of SGX943 for emerging infectious diseases, as well as the development of CiVax and HyBryte. While we continue to receive government funding, fluctuations in grant timing may impact quarterly and annual revenues.

Soligenix’s net loss was $8.3 million, or ($4.98) per share, for the year ended December 31, 2024, compared to $6.1 million, or ($12.66) per share, for the prior year. The change in net loss per share reflects the Company’s one-for-sixteen reverse stock split, which was completed in June 2024. The overall increase in net loss was primarily due to lower revenue, higher research and development expenses associated with clinical trial activities, and changes in tax benefits, partially offset by increased interest income, tax credits and the change in the fair value of debt.

Research and development expenses were $5.2 million as compared to $3.3 million for the years ended December 31, 2024 and 2023, respectively. The increase was primarily related to preliminary costs associated with the initiation of our Phase 2 study in Behçet’s Disease and the second confirmatory Phase 3 CTCL trial offset by an adjustment of estimated accruals for completed clinical trials.

General and administrative expenses were $4.2 million and $4.5 million for the years ended December 31, 2024 and 2023, respectively. The decrease in general and administrative expenses for the three months ended December 31, 2024 was primarily attributable to decreases in legal and consulting expenses.

As of December 31, 2024, the Company’s cash position was approximately $7.8 million.

On March 21, 2025 Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported that the National Medical Products Administration ("NMPA") has approved the supplemental new drug application ("sNDA") for the company’s product, toripalimab, in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma ("HCC") patients (Press release, Shanghai Junshi Bioscience, MAR 21, 2025, View Source [SID1234656130]).

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Globally, liver cancer is a common malignant tumor of the digestive system, and the main pathological type is HCC (accounting for about 90%). According to data released by the GLOBOCAN for 2022, the annual number of new cases and deaths of liver cancer worldwide was 866,000 and 759,000, respectively. China has a high incidence of liver cancer. In 2022, the number of new liver cancer cases reached 368,000 (accounting for 42.4% of global cases), ranking fourth among domestic malignant tumors, with 317,000 deaths (accounting for 41.7% of global cases), ranking second among domestic malignant tumors. Due to its insidious onset, about 70%-80% of liver cancer patients in China are already at the intermediate or advanced stage at first diagnosis, with a median overall survival ("OS") of only approximately 10 months and a five-year survival rate of approximately 12%.

The supplemental NDA approval is based on data from the HEPATORCH study (NCT04723004), which is a multinational multi-center, randomized, open-label, active-controlled phase 3 clinical study. Professor Jia FAN, an academician of the Chinese Academy of Sciences, from Zhongshan Hospital affiliated to Fudan University, served as the principal investigator. HEPATORCH was launched in 57 clinical centers in the Chinese mainland, China’s Taiwan and Singapore, and a total of 326 patients were enrolled. The study aimed to evaluate the efficacy and safety of toripalimab in combination with bevacizumab for the first-line treatment of unresectable or metastatic HCC compared to the standard treatment with sorafenib.

In September 2024, the results of the HEPATORCH study made its debut at the 27th National Clinical Oncology Conference and 2024 Chinese Society of Clinical Oncology (CSCO) Academic Annual Meeting. The results of the study showed that the primary endpoints, progression-free survival ("PFS," based on independent radiographic review) and OS, both achieved positive results.

HEPATORCH demonstrated that compared with sorafenib, toripalimab in combination with bevacizumab could significantly extend the PFS and OS of patients, with a median PFS of 5.8 months vs. 4.0 months, reduce the risk of disease progression or death by 31% (hazard ratio [HR]=0.69, 95% CI: 0.525-0.913; P=0.0086), with a median OS of 20.0 months vs. 14.5 months, and reduce the risk of death by 24% (HR=0.76, 95% CI: 0.579-0.987; P=0.0394). The objective response rate ("ORR") of the toripalimab and bevacizumab group was significantly higher than that of the sorafenib group. The ORR of the two groups were 25.3% and 6.1%, respectively. Furthermore, the combination therapy has a good safety profile in patients with advanced HCC. The toxicity spectrum is consistent with the known toxicity spectrum of the standard monotherapy, and no new safety signal was identified.

Academician Jia FAN from Zhongshan Hospital affiliated with Fudan University said, "The combination of immunotherapy and anti-angiogenic therapy has become the foundation of first-line treatment for advanced liver cancer. The HEPATORCH study has fully demonstrated the clinical efficacy of toripalimab in liver cancer patients in China, achieving an ORR of 25.3%, a median PFS of 5.8 months, and a median OS of 20.0 months. The ‘TB’ regimen combining toripalimab with bevacizumab will benefit many advanced liver cancer patients in China."

Dr. Jianjun ZOU, Junshi Biosciences’ General Manager and CEO said, "Building on the success of our previously approved 10 indications—the ‘Perfect 10,’ toripalimab has reached another breakthrough achievement with the official approval of its 11th indication, and we are extremely elated! China has suffered the brunt of liver cancer, and Chinese patients have long faced the challenge of limited treatment options. Junshi Biosciences consistently prioritizes the clinical needs of liver cancer treatment around the world, advancing clinical research through combination strategies tailored to patients across the different stages of disease progression. Our goal is to provide more precise and diverse treatment options for liver cancer patients. Moving forward, we remain dedicated to liver cancer innovation and integrating even greater ‘Chinese Wisdom’ into the fight against this disease."

About Toripalimab

Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells.

More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Europe and Southeast Asia. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.

In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI). Currently, there are eleven approved indications for toripalimab in the Chinese mainland:

unresectable or metastatic melanoma after failure of standard systemic therapy;
recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy;
locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;
in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;
in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);
in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC);
in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;
in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC);
in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC);
in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC);
in combination with bevacizumab for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) patients.
The first 10 indications have been included in the National Reimbursement Drug List (NRDL) (2024 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of NSCLC, treatment of RCC and treatment of TNBC. In October 2024, toripalimab for the treatment of recurrent or metastatic NPC was approved in Hong Kong SAR, China.

Internationally, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan, Australia and other countries and regions. In addition, toripalimab BLAs are under reviews in many countries or regions around the global.

On March 21, 2025 Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics in immunology and oncology, reported a global strategic collaboration with AstraZeneca to discover and develop next-generation multi-specific antibodies for immunology, oncology and beyond (Press release, Harbour BioMed, MAR 21, 2025, View Source [SID1234651348]). The strategic collaboration includes an option to license multiple programs utilizing Harbour BioMed’s proprietary Harbour Mice fully human antibody technology platform in multiple therapeutic areas and a $105 million equity investment by AstraZeneca in Harbour BioMed.

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Under the terms of the agreements, AstraZeneca will obtain the option to license two preclinical immunology programs and will nominate further targets for Harbour BioMed to discover next generation multi-specific antibodies. AstraZeneca will have the option to license these programs for advancement into clinical development.

The initial phase of the strategic collaboration will focus on ongoing research programs, with the potential for additional programs. In return, Harbour BioMed will receive an upfront payment, near-term milestone payments, and option exercise fees for additional programs, totaling $175 million, as well as up to $4.4 billion in additional development and commercial milestone payments, along with tiered royalties on future net sales. Additionally, the parties have the option to include additional programs into the collaboration over the next five years, with the option to extend the terms of the agreement for an additional five years upon mutual agreement.

Furthermore, AstraZeneca will acquire 9.15% newly issued shares of Harbour BioMed.

To support the collaboration programs under this agreement and other joint initiatives between the two parties, Harbour BioMed will establish an innovation center in Beijing, China to be co-located with AstraZeneca.

Jingsong Wang, MD, PhD, Founder, Chairman, and CEO of Harbour BioMed, commented: "This strategic collaboration with AstraZeneca marks a significant step in advancing next-generation antibody therapeutics, reinforcing Harbour BioMed’s position as a leader in multi-specific biologics innovation. By leveraging our cutting-edge discovery capabilities and AstraZeneca’s expertise in drug development, we aim to accelerate the creation of transformative therapies for patients with high unmet medical needs."

On March 21, 2025 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) reported its full-year results for the period ending December 31, 2024, along with several significant milestones achieved in recent months (Press release, Antengene, MAR 21, 2025, View Source [SID1234651349]).

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Dr. Jay Mei, Antengene’s Founder, Chairman, and CEO, stated, "To Antengene, 2024 was indeed an extraordinary year in which we achieved remarkable progress on multiple fronts, including clinical development, R&D and commercialization. ATG-022, our Claudin 18.2 antibody-drug conjugate that is being evaluated in a Phase II study in Australia and China, has shown highly differentiated clinical potential, demonstrating efficacy not only in gastric cancer patients with mid to high Claudin 18.2 expressions, but also unprecedented clinical benefit for patients with low or ultra-low expressions. Furthermore, AnTenGagerTM TCE 2.0, Antengene’s proprietary platform incorporating steric hindrance-masking technology, has shown impressive capabilities, with its preclinical data demonstrating a significantly more favorable safety profile than those of the first-generation TCE platforms, and potential clinical efficacy covering solid tumors, hematologic malignancies and autoimmune diseases. We will seek various forms of collaboration with global partners around this technology platform in order to fully unlock its potential value. ATG-201, a CD19 x CD3 TCE 2.0 developed on the AnTenGageTM TCE 2.0, is poised to enter clinical development in the second half of 2025.

In addition to the rapid progress in R&D and clinical development, we also achieved impressive results in commercialization. Our first approved product, XPOVIO, has clearly picked up momentum in its global expansion while having its second indication approved and included in the NRDL in China. Also during the reporting period, XPOVIO was included for reimbursement in South Korea and Taiwan China, and approved for commercialization in Malaysia, Thailand, and Indonesia. To date, XPOVIO has been approved in 10 APAC markets and included for reimbursement coverage in 5 of those markets. Currently, the company has a cash reserve of RMB 900 million which is sufficient to fund its continued operations over the next three years even without future revenue income. We look forward to updating you all on our progress in 2025, with the next one being the latest results on the AnTenGageTM TCE 2.0, scheduled for release at this year’s AACR (Free AACR Whitepaper) Annual Meeting."

1. Claudin 18.2 ADC Demonstrates Significant Clinical Value, with Multiple Programs Advancing Steadily at the Clinical Stage

ATG-022（Claudin 18.2 Antibody-Drug Conjugate, ADC）
Unique Therapeutic Potential: ATG-022 is a highly differentiated ADC demonstrated efficacy across the broadest range of CLDN18.2 expression levels. Clinical data show that ATG-022 not only effectively targets gastric cancer patients with high CLDN18.2 expression but is also effective in tumors with low and ultra-low CLDN18.2 expression. Additionally, ATG-022 has shown better safety profile without accumulative systemic toxicities, and much fewer dose-limiting toxicities and lower high grade adverse effects compared to other CLDN 18.2 ADCs in similar clinical development stages. It also has received two Orphan Drug Designations (ODDs) from the U.S. Food and Drug Administration (FDA) for the treatment of gastric and pancreatic cancer.
Ongoing CLINCH study: As of November 22, 2024, among 21 gastric cancer patients in the dose expansion phase with CLDN18.2 expression at IHC 2+ ≥ 20% achieved an Objective Response Rate (ORR) of 42.9% and a Disease Control Rate (DCR) of 95.2% (9 patients had Partial Responses [PR], 8 of which were confirmed; 11 patients had Stable Disease [SD]). Additionally, 10 patients with CLDN18.2 expression at IHC 2+ < 20% treated at efficacious doses of 1.8 – 2.4 mg/kg had an ORR of 30.0% (1 patient achieved a Complete Response [CR], 2 achieved PR, and all confirmed CR/PR cases had CLDN18.2 expression IHC 2+ < 5%), with a DCR of 50.0%. The patient who achieved a CR has demonstrated sustained remission and has been in the study for over 14 months as of the data cut-off date. The Phase II CLINCH study is progressing smoothly in China and Australia.
Other Clinical Stage Programs
ATG-037 (CD73 Small Molecule Inhibitor): ATG-037 has demonstrated pre-clinically the ability to overcome the "hook effect" that can limit efficacy and is commonly seen in anti-CD73 antibodies. Antengene entered into a global clinical collaboration with MSD and is currently evaluating this molecule in combination with the anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with anti-PD-1 resistant melanoma and non-small cell lung cancer (NSCLC). At the 2024 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, clinical data from the ongoing Phase I STAMINA dose-escalation study were presented in a Mini Oral session. As of the latest data cut-off date on November 27, 2024, among the 26 evaluable patients with prior anti-PD-1 resistance who received ATG-037 in combination with pembrolizumab, 9 had NSCLC and 11 had melanoma. Among these patients, the ORR is 35% and DCR is 85%. These data indicate that ATG-037 has the potential to reverse anti-PD-1 resistance during the dose-escalation phase. Currently, the Phase II STAMINA dose optimization and expansion study is progressing smoothly in China and Australia.
ATG-031 (Anti-CD24 Monoclonal Antibody): ATG-031 is the first-in-class humanized anti-CD24 monoclonal antibody to enter clinical trials for cancer in the U.S. ATG-031 works by blocking CD24-Siglec10 and enhancing macrophage-mediated phagocytosis of cancer cells. Key study sites of ATG-031 include four renowned cancer centers in the United States: MD Anderson Cancer Center at the University of Texas, University of California, San Francisco (UCSF), University of Colorado, and Yale Cancer Center. The Phase I PERFORM study is progressing smoothly in the U.S.
2. The Exciting Proprietary AnTenGagerTM TCE 2.0 with Steric Hindrance-masking Technology

Next-Generation TCE Platform: The AnTenGagerTM TCE 2.0 is Antengene’s proprietary "2+1" TCE platform which features a steric hindrance-masking technology designed to enable disease-associated antigen (DAA)-dependent T-cell activation. This approach is intended to achieve potent therapeutic activity while reducing the risk of cytokine release syndrome (CRS). Compared to first-generation TCE platforms, AnTenGagerTM TCE 2.0 offers better safety and has broader applicability in different indications such as in solid tumors, hematological malignancies, and autoimmune diseases. Additionally, AnTenGagerTM TCE 2.0 has a longer half-life, which allows for reduced dosing frequency and improved clinical convenience. The company will continue to advance the development of AnTenGagerTM TCEs.
Global Collaborations: Antengene will seek a range of collaborations with its global partners for the AnTenGageTM TCE 2.0, through platform access, co-development, and out-licensing, in order to enable the accelerated development of an ecosystem around TCE therapeutics and maximize the value of the technology platform.
ATG-201 (CD19 x CD3 TCE 2.0): ATG-201 is a novel "2+1" CD19-targeted T-cell engager developed using the AnTenGagerTM TCE 2.0 for the treatment of B cell related autoimmune diseases. In preclinical studies, ATG-201 demonstrated superior B-cell depletion compared to benchmark molecules, along with reduced cytokine release. The company expects ATG-201 to enter clinical development in the second half of 2025.
Antengene will continue to advance other preclinical programs, including ATG-042 (a selective PRMT5 inhibiting targeting MTAP-null tumors), ATG-106 (CDH6 x CD3 TCE 2.0) for ovarian and renal cancer, and ATG-110 (LY6G6D x CD3 TCE 2.0) for microsatellite stable (MSS) colorectal cancer.
3. Accelerating Global Expansion: Covering 10 APAC Markets

Mainland of China: In July 2024, XPOVIO received approval for a second indication in Mainland China, providing a new treatment option for Chinese DLBCL patients. In November 2024, this indication was included in the National Reimbursement Drug List (NRDL). As of now, both approved indications of XPOVIO in China are covered under national insurance, further expanding patient access.
South Korea: In June 2024, XPOVIO received national reimbursement approval in Korea, effective from July 1, 2024. In October 2024, XPOVIO was approved for an additional third indication in Korea. The company is actively working to expand reimbursement coverage for more indications in Korea.
Taiwan Market: In February 2025, XPOVIO received national reimbursement approval in Taiwan market, making it the fifth APAC market to secure reimbursement coverage after mainland of China, South Korea, Australia, and Singapore.
ASEAN Markets: Since August 2024, XPOVIO has been successively approved in Malaysia, Thailand, and Indonesia, marking significant progress in Antengene’s commercialization strategy across the APAC region. XPOVIO is now approved in 10 countries and regions across APAC for multiple indications.
4. Strong Cash Reserves to Support Continuous Growth

As of December 31, 2024, the company held RMB 900 million in cash and bank balances, which is sufficient to fund the company’s continuous growth and operations over the next three years even without additional financing.