Roxadustat

FG-3246 showed encouraging anti-cancer activity with an acceptable safety profile in patients with metastatic castration-resistant prostate cancer Initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC expected by mid-2025 SAN FRANCISCO, March 28, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced the peer-reviewed publication titled “A Phase 1, First-in-Human Study of FOR46 (FG-3246), an Immune-Modulating Antibody-Drug Conjugate Targeting CD46, in Patients with Metastatic Castration Resistant Prostate Cancer” in the Journal of Clinical Oncology. The manuscript includes the complete results from the Fortis Therapeutics-sponsored Phase 1 study of FOR46 (now known as FG-3246), a potential first-in-class anti-CD46 antibody drug conjugate (ADC) with an MMAE-containing payload, in patients with metastatic castration-resistant prostate cancer (mCRPC). “I am excited to see the results from the Phase 1 monotherapy study of FOR46 (FG-3246) published in the Journal of Clinical Oncology. This is the first clinical trial targeting CD46 in patients with prostate cancer, and the totality of the data highlights the promising potential of FG-3246 anti-cancer activity, especially when considering the unselected, heavily pre-treated patient population in the trial. The trial results provide key insights into the potential clinical impact of targeting CD46 in the treatment of mCRPC and support its further development in this disease space with high unmet need,” said Dr. Rahul Aggarwal, Professor of Medicine at the University of California San Francisco, and Principal Investigator of the study. “We are looking forward to advancing FG-3246 in the clinic and remain on track for initiating the Phase 2 monotherapy study by mid-2025 as well as disclosing topline results from the combination trial of FG-3246 and enzalutamide in the second half of 2025,” added Thane Wettig, Chief Executive Officer of FibroGen. “FG-3246 represents a potential first-in-class, non-PSMA approach to treating mCRPC and we, along with the medical community, are excited about the potential for CD46 to become a next generation target in the prostate cancer treatment paradigm.” This Phase 1 study was a multi-center, first-in-human, open label dose escalation and expansion study evaluating the safety, tolerability, and anti-tumor activity as measured by the decline of prostate-specific antigen (PSA) from baseline, objective tumor response rate in patients with measurable disease, and radiographic progression free survival (rPFS). The completed Phase 1 trial includes a total of 56 patients from the dose-escalation and dose-expansion cohorts. Notably, patients were biomarker unselected and heavily pre-treated, having received a median of 5 lines of therapy prior to receiving FG-3246. Key highlights from the publication include: The maximally tolerated dose of FG-3246 was 2.7 mg/kg by adjusted body weight (AjBW) every 3 weeks The most frequent adverse events were consistent with other MMAE-based ADCs and included infusion related reactions (48.2%), neutropenia (41.1%), and peripheral neuropathy (32.1%). Ocular adverse events were infrequent, which may be a distinguishing feature compared with other MMAE-based ADCs Efficacy observed in the RECIST-evaluable set of 25 patients: Confirmed objective response rate was 20% with median duration of response of 7.5 months All objective responses observed at a starting dose of 2.7 mg/kg or higher Disease control rate was 80% with duration of treatment exceeding 24 weeks in 12 patients (48%) PSA50 response rate of 36% in 39 evaluable patients Of eight evaluable patients who received docetaxel in the castration-sensitive setting, four (50%) achieved a confirmed PSA50 response Median radiographic progression-free survival of 8.7 months in all 40 subjects in the efficacy analysis set Of 15 evaluable baseline tumors, 12 (80%) were positive for CD46 expression by immunohistochemistry FG-3246 responders were found to have a significantly higher frequency of effector T cells and lower frequency of immunosuppressive myeloid cells Ocular adverse events were infrequent, which may be a distinguishing feature compared with other MMAE-based ADCs Confirmed objective response rate was 20% with median duration of response of 7.5 months All objective responses observed at a starting dose of 2.7 mg/kg or higher Disease control rate was 80% with duration of treatment exceeding 24 weeks in 12 patients (48%) All objective responses observed at a starting dose of 2.7 mg/kg or higher Of eight evaluable patients who received docetaxel in the castration-sensitive setting, four (50%) achieved a confirmed PSA50 response The Company anticipates initiating the Phase 2 monotherapy dose optimization study of FG-3246 in patients with mCRPC by mid-2025. FG-3246 is also being evaluated in combination with enzalutamide in an investigator-sponsored study with topline results from the Phase 2 portion of the study anticipated in 2H 2025. About the Phase 1 Study FOR46-001 (NCT03575819) is a Phase 1, dose-escalation study sponsored by Fortis Therapeutics to evaluate multiple doses of IV-administered FG-3246 (also known as FOR46) in patients with mCRPC who have progressive disease on at least one ARSI, followed by a dose-expansion cohort, to evaluate the safety, tolerability, PK, biological activity, and preliminary evidence of anti-tumor activity of FG-3246 in this patient population. Thirty-three (33) patients were enrolled in the dose-escalation phase of the study at doses between 0.1 mg/kg and 3.0 mg/kg every three weeks (Q3W), with adjusted body weight dosing (AjBW) used at most dose levels above 2.1 mg/kg. Safety and tolerability of FG-3246 were evaluated in the dose-escalation period of the study. Twenty-three (23) patients were enrolled in the dose-expansion period of the study; 18 patients with adenocarcinoma mCRPC (Cohort 1) and five patients with neuroendocrine prostate cancer (Cohort 2). All patients in the expansion cohorts were treated at 2.7 mg/kg AjBW to a maximum of 270 mg every three weeks. The safety profile of FG-3246 was characterized, and anti-tumor activity of FG-3246 in adenocarcinoma patients dosed at ≥ 1.2 mg/kg was evaluated. About Metastatic Castration-Resistant Prostate Cancer Prostate cancer is the second most common malignancy in men, contributing significantly to male mortality rates. Approximately 13% of men will be diagnosed with prostate cancer at some point during their lifetime. There are about 65,000 drug treatable mCRPC cases in the U.S. annually and 5-year survival in mCRPC is approximately 30%1. About FG-3246 FG-3246 (also known as FOR46) is a potential first-in-class, fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by FibroGen for metastatic castration-resistant prostate cancer and other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies. FG-3246 is currently in an ongoing Phase 1/2 study being conducted at UCSF to evaluate it in combination with enzalutamide with topline data from the Phase 2 portion of the study expected in the second half of 2025, and a biomarker trial using a PET biomarker for CD46 using the same antibody backbone. We anticipate the initiation of the Phase 2 monotherapy dose optimization trial in metastatic castration-resistant prostate cancer by mid-2025. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority. About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia. Roxadustat (爱瑞卓®, EVRENZOTM) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit www.fibrogen.com. Forward-Looking Statements This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its collaboration partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential clinical or commercial success of FibroGen products and product candidates, and statements about FibroGen’s plans and objectives. These forward-looking statements are typically identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. FibroGen’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s Annual Report on Form 10-K for the most recent fiscal year, and any more recent Quarterly Reports on Form 10-Q, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law. References: 1. Seer.cancer.gov https://seer.cancer.gov/statfacts/html/prost.html For Investor Inquiries: David DeLucia, CFA Senior Vice President and Chief Financial Officer ir@fibrogen.com Source: FibroGen, Inc.

February 2025 witnessed a wave of mergers and acquisitions in the global biopharmaceutical sector. From Pacira BioSciences acquiring GQ Bio Therapeutics GmbH for $32 million to accelerate the development of gene therapy, to Novartis making a $925 million investment to acquire Anthos Therapeutics and its potentially first-in-class drug abelacimab, the industry saw significant strategic moves. Meanwhile, Shen Lian Biomedical’s entry into the human innovative drug sector and Bosai Gene’s acquisition of certain assets of Skyline Therapeutics Limited further underscore the rising presence of Asian biotech companies on the global stage. 1.Pacira BioSciences Acquires GQ Bio to Advance Innovative Gene Therapies for Chronic Musculoskeletal Diseases On February 27, 2025, Pacira BioSciences announced the acquisition of the remaining 81% equity of GQ Bio Therapeutics GmbH for a net purchase price of approximately $32 million. This acquisition not only strengthens Pacira’s leadership in non-opioid pain management but also aligns with its "5x30" strategy, aimed at becoming an innovative biopharmaceutical organization. Through this transaction, Pacira has integrated GQ Bio’s High-Capacity Adenovirus (HCAd) gene therapy vector platform, which is particularly well-suited for developing disease-modifying therapies for common musculoskeletal disorders. The HCAd platform addresses key challenges in gene therapy, such as efficiently delivering large or multi-gene constructs into cells. Unlike many gene therapies that rely on Adeno-Associated Virus (AAV) vectors, the HCAd vector enables more effective gene delivery with significantly lower doses. Additionally, the HCAd platform can carry up to 30,000 base pairs of DNA, supporting multigenic or large-gene therapies. This allows for localized administration and repeat dosing at appropriate therapeutic intervals, significantly enhancing the feasibility and commercial appeal of gene therapy. Pacira's lead candidate, PCRX-201 (enekinragene inzadenovec), originally developed by GQ Bio, leverages this innovative HCAd technology and is currently in clinical development for knee osteoarthritis. Administered via local injection into the knee joint, PCRX-201 promotes the cellular production of interleukin-1 receptor antagonist (IL-1Ra), thereby blocking the IL-1 pathway activation and reducing chronic inflammation. A key feature of PCRX-201 is its inflammation-responsive promoter, which ensures IL-1Ra is only produced when needed, mimicking the body's natural anti-inflammatory response. Preliminary clinical data suggest that PCRX-201 provides sustained relief for up to two years, improving pain, stiffness, and joint function while maintaining a favorable safety profile. This acquisition brings both short-term and long-term financial benefits for Pacira, eliminating up to $64 million in future milestone payment obligations. Pacira intends to maintain GQ Bio’s operations, invest in its HCAd gene therapy vector platform, and develop innovative products based on this technology. Leveraging Pacira’s clinical, regulatory, and commercialization expertise, the company aims to maximize the potential of GQ Bio’s platform. Additionally, the two companies have identified multiple well-validated cytokines as potential foundations for additional localized gene therapies, further expanding the HCAd platform’s applications to address unmet medical needs. Pacira remains committed to revolutionizing non-opioid pain management to enhance patient quality of life. The acquisition of GQ Bio and its HCAd platform not only solidifies Pacira’s leadership in musculoskeletal pain and related disorders but also offers new hope to millions of patients suffering from chronic pain—a condition affecting nearly one-quarter of the U.S. population. By tackling the underlying molecular causes of chronic pain, Pacira demonstrates its dedication and capability in addressing this national public health challenge. 2.Bosai Gene Acquires Certain Assets of Skyline Therapeutics Limited Bosai Gene plans to acquire certain assets of Skyline Therapeutics Limited (Jiutian Cayman) using its own funds. This transaction aims to enhance the company’s sustainable development capabilities in the biotechnology sector. The acquisition scope includes assets of Jiutian Cayman and its subsidiaries, excluding its wholly owned subsidiary, Skyline Therapeutics (US) Inc., and any assets or rights it has obtained. Through this acquisition, Bosai Gene expects to integrate resources, drive technological innovation, and establish a stronger position in the international market. The total transaction consideration consists of a base merger consideration of $15 million and an additional merger consideration of up to $43 million. The additional merger consideration is composed of development and sales milestone payments, sublicensing royalties, and sales royalties calculated as a single-digit percentage of annual net sales. All payments will be made in U.S. dollars, introducing a degree of foreign exchange risk due to fluctuations in the Renminbi to U.S. dollar exchange rate. Jiutian Cayman specializes in the biotechnology field, possessing extensive R&D experience and multiple potentially high-value drug pipelines. Although the announcement does not specify particular drug names or mechanisms of action, considering the characteristics of the biotech industry, these drugs are likely to involve innovative therapies, such as gene therapy, cell therapy, or other advanced biologics. These therapies typically target specific molecular pathways to achieve therapeutic effects, offering breakthrough potential for certain refractory diseases. Through this acquisition, Bosai Gene stands to gain access to a range of competitive R&D projects and technology platforms, further enriching its product pipeline. Upon completion of the acquisition, Jiutian Cayman will become a wholly owned subsidiary of Bosai Gene and will be consolidated into the company’s financial statements. However, differences in corporate culture and management practices between the two entities present integration challenges. To maximize synergies, Bosai Gene plans to implement a series of measures, including but not limited to internal controls, financial management, human resources management, and technical R&D support, ensuring the acquired company maintains a stable development trajectory. Furthermore, to retain key personnel, Bosai Gene has engaged in extensive discussions with critical employees of the target company and has established corresponding incentive mechanisms. The transaction is subject to approval or filing with relevant government authorities and must be ratified by Jiutian Cayman’s shareholder meeting, requiring at least two-thirds of voting rights in favor for it to become effective. As a result, there remains uncertainty regarding the successful completion of the transaction. Additionally, risks associated with exchange rate fluctuations, goodwill impairment, key personnel departures, and other potential uncertainties must be considered. In response, Bosai Gene has formulated corresponding risk mitigation strategies and may adjust transaction terms if necessary to safeguard the company’s interests. As of the announcement date, relevant preparatory work is proceeding in an orderly manner. 3.Cosette Pharmaceuticals Acquires Mayne Pharma, Strengthening Leadership in Women’s Health and Dermatology Cosette Pharmaceuticals, Inc. has announced that it has entered into a definitive agreement to acquire all issued shares of Mayne Pharma Group Limited at a price of AUD 7.40 per share, with a total transaction value of approximately $430 million. This acquisition has been approved by the boards of directors of both companies, and Mayne Pharma’s board has unanimously recommended that its shareholders vote in favor of the transaction. The deal is expected to close in Q2 2025. Through this acquisition, Cosette Pharmaceuticals aims to strengthen its business in women’s health and dermatology, while expanding its commercial, manufacturing, and geographical footprint. The acquisition will establish Cosette Pharmaceuticals as a leading U.S.-based pharmaceutical company specializing in women’s health and dermatology, while also expanding its international market presence. The combined company will leverage the strengths of both firms in these specialized areas to drive innovation and enhance the accessibility of women’s health therapies. Notably, Cosette will acquire 12 patent-protected products, including well-known brands such as VYLEESI®, INTRAROSA®, NEXTSTELLIS®, and ANNOVERA®. For example, VYLEESI® is used to treat hypoactive sexual desire disorder (HSDD), while INTRAROSA® is prescribed for postmenopausal vaginal atrophy symptoms. The combined entity will have a workforce of over 830 employees, including a highly effective and successful sales and marketing team, particularly in the specialized fields of women’s health and dermatology. Additionally, the company will own two state-of-the-art, FDA-approved manufacturing facilities—one located in Lincolnton, North Carolina, and the other in Salisbury, South Australia. These facilities will serve global patients, ensuring a consistent supply of high-quality pharmaceutical products. The acquisition will also enhance Cosette’s already robust product portfolio, reinforcing its market-leading commercial and operational capabilities. Under the terms of the agreement, the acquisition will be executed via a scheme of arrangement, involving the 100% acquisition of all issued shares of Mayne Pharma. The transaction is expected to close in Q2 2025, subject to customary closing conditions, including regulatory and shareholder approvals. Upon completion, the combined company will be privately held. Both companies’ boards of directors have approved the transaction and have recommended that Mayne Pharma’s shareholders vote in favor of the deal, provided no superior offer emerges. Further details on the transaction can be found in Mayne Pharma’s announcement to the ASX. 4. FibroGen Announces Sale of Its China Subsidiary to AstraZeneca On February 20, 2025, FibroGen, Inc. announced that it has agreed to sell its China subsidiary to AstraZeneca for approximately $160 million. The purchase price of this transaction includes an enterprise value of $85 million, along with FibroGen’s net cash holdings in China, currently estimated at approximately $75 million. This transaction not only strengthens FibroGen’s financial position but also extends its cash runway through 2027, enabling the company to continue advancing the clinical development of FG-3246 (an antibody-drug conjugate targeting CD46) and FG-3180 (a companion PET imaging agent) in metastatic castration-resistant prostate cancer (mCRPC). Under the terms of the agreement, upon completion of the transaction, AstraZeneca will acquire all rights to roxadustat in China. Roxadustat is a leading brand in the treatment of anemia associated with chronic kidney disease (CKD), holding a significant market share, and is currently awaiting regulatory decisions for chemotherapy-induced anemia. Following the completion of this transaction, FibroGen will retain the rights to roxadustat in the U.S. and all markets not licensed to Astellas. The company plans to meet with the FDA in the second quarter of 2025 to discuss potential next steps for developing roxadustat for the treatment of anemia in patients with low-risk myelodysplastic syndromes (LR-MDS) in the U.S. The transaction is expected to close in mid-2025, subject to customary closing conditions, including regulatory review in China. Upon completion, FibroGen will use a portion of the proceeds to repay a term loan provided by Morgan Stanley Tactical Value Investing Fund, further streamlining the company’s capital structure. Additionally, FibroGen reported unaudited total cash, cash equivalents, and accounts receivable of $121.1 million as of December 31, 2024. This indicates that, with this transaction, the company’s cash reserves will be sufficient to support its operations through 2027. FibroGen will continue to advance its key assets, FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate targeting CD46, and its companion PET imaging agent, FG-3180. A Phase II clinical trial evaluating FG-3246 as a monotherapy for mCRPC patients is expected to commence in the second quarter of 2025. These research and development efforts are crucial for expanding the company’s oncology pipeline and demonstrating its commitment to developing innovative therapies. 5. Gate Neurosciences Strengthens Synapse-Targeted Therapeutics Through Acquisition of Boost Neuroscience Gate Neurosciences announced that it has entered into a definitive agreement to acquire Boost Neuroscience and its leading proprietary platform, which focuses on human synaptic network analysis and the discovery and development of synapse-targeting therapeutics. This acquisition further strengthens Gate Neurosciences’ leadership in synapse science and drug development, providing cutting-edge insights into human synaptic network pharmacology. Boost Neuroscience was spun out from the laboratory of Dr. Thomas Südhof at Stanford University and was backed by Catalio Capital Management. Dr. Südhof was awarded the 2013 Nobel Prize in Physiology or Medicine for his research on synaptic transmission and biology. Boost Neuroscience has developed a proprietary platform utilizing human induced pluripotent stem cells (iPSCs) to model neuronal network circuits, offering unprecedented insights into how molecules influence neuronal network formation, synaptogenesis, synaptic function, and neuroplasticity. The company aims to discover and develop novel therapies that enhance synaptic health and function to address a range of central nervous system (CNS) disorders. Based in Menlo Park, California, Boost Neuroscience’s laboratory and office space are equipped with state-of-the-art automated microscopy and robotics technology, complementing Gate Neurosciences’ existing translational research facility in Evanston, Illinois. Through this acquisition, Gate Neurosciences will enhance its translational research capabilities in synaptic function pharmacology, further bolstering confidence in its internal clinical programs. Additionally, Boost Neuroscience’s early-stage pipeline will expand Gate Neurosciences’ portfolio by introducing new target programs. Notably, Boost’s proprietary platform is capable of identifying and validating targets and molecular scaffolds that enhance human synaptic function, offering potential treatments for a wide range of neuropsychiatric and neurodegenerative diseases driven by synaptic dysfunction. Synaptic dysfunction and loss are well-established precursors to neuropsychiatric and neurodegenerative diseases. The addition of Boost Neuroscience will accelerate Gate Neurosciences’ efforts in translating synapse-targeting drug projects into successful therapies. Dr. Jacob Vogelstein, Managing Partner at Catalio Capital Management, remarked, “The Gate Neurosciences team has made significant progress in advancing translational pharmacology for synapse-targeted therapeutics.” He further emphasized that this integration will accelerate the development of a leading pipeline to treat major neurological and neuropsychiatric disorders driven by synaptic dysfunction. 6.Novartis Acquires Anthos Therapeutics for $925 Million to Strengthen Its Late-Stage Cardiovascular Pipeline On February 11, 2025, Novartis announced an agreement to acquire Anthos Therapeutics, a Boston-based clinical-stage biopharmaceutical company developing abelacimab, a potentially first-in-class monoclonal antibody targeting the FXI inhibition pathway. This transaction aligns with Novartis’ growth strategy and therapeutic focus, leveraging the company’s expertise and leadership in the cardiovascular space. Under the terms of the agreement, Novartis will pay $925 million upfront upon transaction closing, with potential additional payments of up to $2.15 billion contingent upon achieving specific regulatory and sales milestones. The transaction is expected to close in the first half of 2025, subject to customary closing conditions. Abelacimab is a novel, highly selective, fully human monoclonal antibody designed to provide effective anticoagulation with hemostasis preservation via Factor XI inhibition. Phase 2 data have demonstrated a significant reduction in bleeding events in atrial fibrillation (AF) patients treated with abelacimab compared to standard-of-care direct oral anticoagulants (DOACs). Currently, three Phase 3 clinical trials are underway, targeting patients at risk of arterial and venous thrombosis, including AF patients (LILAC-TIMI 763) and cancer-associated thrombosis (ASTER4 and MAGNOLIA5). Additionally, in 2022, abelacimab received Fast Track designation from the FDA for the treatment of cancer-associated thrombosis and the prevention of stroke and systemic embolism in AF patients. Through this acquisition, Anthos Therapeutics will join Novartis, further strengthening its cardiovascular focus while complementing the company’s life-changing therapies, comprehensive clinical programs, and strategic collaborations. Dr. Shreeram Aradhye, President of Development and Chief Medical Officer at Novartis, stated, “We are thrilled to join forces to advance abelacimab, a potentially first-in-class therapy offering a safer approach for atrial fibrillation and cancer-associated thrombosis.” This acquisition not only enhances Novartis’ cardiovascular pipeline but also underscores its commitment to addressing the needs of cardiovascular patients worldwide. As a potential first-in-class therapy, abelacimab aims to offer a more effective and safer approach to preventing thrombosis and stroke compared to the current standard of care. The drug works by selectively targeting Factor XI, a key protein in the blood coagulation cascade. By inhibiting Factor XI, abelacimab reduces unnecessary clot formation while preserving normal hemostatic function. This unique mechanism makes abelacimab highly promising for the prevention of stroke and systemic embolism in AF patients, as well as the treatment of cancer-associated thrombosis. Under the terms of the agreement, in addition to the $925 million upfront payment, Novartis may pay up to $2.15 billion in milestone-based payments based on regulatory and commercial achievements. This acquisition reflects Novartis’ commitment to investing in innovative therapies and its long-term dedication to advancing cardiovascular disease treatments. With abelacimab now integrated into Novartis’ Cardiovascular, Renal, and Metabolism (CRM) development pipeline, the company looks forward to further clinical advancements that could unlock its full therapeutic potential. 7.Alumis and ACELYRIN Merge to Advance Transformative Therapies for Immune-Mediated Diseases On February 6, 2025, Alumis Inc. and ACELYRIN, INC. announced a definitive merger agreement to combine in an all-stock transaction, forming a late-stage clinical biopharmaceutical company dedicated to the innovation, development, and commercialization of transformative therapies for immune-mediated diseases. The merged entity will operate under the Alumis name and be led by the current Alumis executive team. Under the agreement, shareholders of Alumis and ACELYRIN will own approximately 55% and 45% of the combined company, respectively (on a fully diluted basis). This merger not only provides a value-driven opportunity for shareholders but also marks a significant step forward in advancing new treatments that can transform patients’ lives. Alumis’ lead candidate, ESK-001, is in development for the treatment of moderate-to-severe plaque psoriasis, with pivotal Phase 3 ONWARD trial data expected in the first half of 2026. Additionally, data from the Phase 2b LUMUS trial for systemic lupus erythematosus (SLE) is anticipated in 2026. Meanwhile, ACELYRIN’s development plans for lonigutamab are under evaluation to confirm its differentiation and capital-efficient advancement. Although the specific mechanism of action for lonigutamab has not been disclosed in detail, it is expected to provide a novel approach to treating immune-mediated diseases. As of December 31, 2024, Alumis and ACELYRIN held approximately $289 million and $448 million, respectively, in cash, cash equivalents, and marketable securities. The combined company is expected to have a pro forma cash balance of approximately $737 million, which is projected to sustain operations through 2027. This funding will support multiple key clinical trial readouts, operating expenses, and capital expenditures. The merger provides financial flexibility, allowing the company to advance its expanded late-stage pipeline, including lonigutamab, while also building commercial capabilities. This merger represents a powerful strategic and financial combination, enabling the combined company to advance its pipeline across multiple clinical-stage trials while bringing new treatment options to patients. By 2026, with multiple pivotal data readouts, the company expects to demonstrate its product pipeline’s potential and generate significant value for shareholders. Furthermore, the merged company will maintain financial discipline and a flexible capital allocation strategy to maximize the value of its highly differentiated portfolio. 8.Shen Lian Biomedical Ventures into the Human Innovative Drug Sector On February 6, 2025, Shen Lian Biomedical announced an investment of RMB 60 million in Shizhiyuan Biotechnology, acquiring a 20.48% equity stake in the company. This move marks Shen Lian Biomedical's official entry into the human innovative drug sector, signifying a crucial step toward its transformation into a high-tech biopharmaceutical enterprise. Shizhiyuan Biotechnology is a high-tech company specializing in the research, development, and production of innovative drugs, holding commercialization rights in mainland China for three investigational new drugs targeting allergies, HIV treatment, and herpes simplex virus. Among them, the HIV treatment monoclonal antibody UB-421 stands out. Originally developed by United Biomedical and licensed from United BioPharma, UB-421 targets the host CD4 receptor, offering a novel therapeutic approach for HIV. Research has demonstrated that UB-421 can significantly increase CD4+ T cell counts and reduce the HIV reservoir without inducing viral resistance mutations. This highlights its significant potential as a direct-acting or adjunctive therapy for patients harboring multidrug-resistant or pan-resistant virus strains. Particularly for patients exhibiting high resistance to most antiretroviral drugs and broadly neutralizing antibodies, UB-421 provides new hope. Shen Lian Biomedical was the first company globally to apply synthetic peptide technology to veterinary biologics and achieve large-scale commercialization. It has established a comprehensive and leading technological system, particularly excelling in long-chain peptide synthesis. The company has mastered solid-phase synthesis for peptides exceeding 100 amino acids and possesses the capability for stable, kilogram-scale mass production. Additionally, Shen Lian Biomedical is the world's first enterprise to apply circular mRNA technology to veterinary biologics, boasting a complete and independently developed intellectual property system. These technological advantages lay a solid foundation for the company’s expansion into the human innovative drug sector. Conclusion Reflecting on the global biopharmaceutical M&A activities in February 2025, several key trends and developments emerge. First, technological innovation remains the core driver of industry growth. Whether it is Pacira BioSciences’ acquisition of GQ Bio to gain access to the high-capacity adenoviral (HCAd) gene therapy vector platform or Gate Neurosciences’ integration of Boost Neuroscience’s expertise to strengthen its leadership in synaptic science research, these investments underscore the importance of cutting-edge technologies in advancing new therapeutic approaches. Second, with Cosette Pharmaceuticals acquiring Mayne Pharma, we observe how companies leverage mergers to consolidate their market position in specific therapeutic areas and expand geographic reach. This not only enhances drug accessibility but also provides patients with more treatment options. Additionally, FibroGen’s sale of its China subsidiary to AstraZeneca highlights the potential of cross-border collaborations in optimizing resource allocation, improving financial standing, and advancing R&D projects. Finally, the merger of Alumis and ACELYRIN signals a potential trend where more mid-sized biotechnology firms specializing in specific disease areas may join forces to achieve economies of scale and technological synergy, addressing complex medical challenges collectively. In summary, the M&A activities in February 2025 reflect dynamic shifts in the biopharmaceutical industry and lay the foundation for future trends. With technological advancements and increasing market globalization, more cross-regional and cross-disciplinary collaborations are expected to emerge, facilitating resource integration and knowledge sharing to propel global healthcare forward. These mergers are not merely financial maneuvers but strategic efforts to explore and shape the future of pharmaceutical innovation, demonstrating the industry’s relentless pursuit of improving public health worldwide. How to get the latest progress on drug deals? If you would like to access the latest transaction event information, you can click on the 'Deal' module from the homepage of the Synapse database. Within the Deal module, you can search for global pharmaceutical transaction information using labels such as Drugs, Organization, Target, Drug Type, Deal Date.  Furthermore, you can obtain the original link to the transaction coverage by clicking on the "Deal Name." In the analysis view, you can see the most active assignors, assignees, popular targets, and other dimensions of analysis, as well as the distribution of research and development statuses at the time of the transaction, to help you better understand the search results. The Synapse database also supports the ability to view current transactions from the dimension of "drugs" (by selecting "drugs" from the "Adjust Dimension" dropdown menu above). Targeting transactions involving renowned pharmaceutical companies that are of interest to the industry, such as Merck, Roche, etc., Synapse has identified a group of "leading companies" through drugs that have achieved global sales exceeding 1 billion US dollars in 2022. Transactions involving drugs from these leading companies can be filtered by clicking on the "Leading Company" tag on the left-hand side. In addition to the drug transaction module, you can also view related transaction history on the drug detail page and the institution detail page. Click on the image below to explore new pharmaceutical funding transactions!