Desvenlafaxine Fumarate

In April 2025, a series of innovative drugs targeting various disease areas received regulatory approval, ranging from rare diseases such as dystrophic epidermolysis bullosa (DEB) to more prevalent conditions like chronic urticaria, polyarticular juvenile idiopathic arthritis (pJIA), and hospital-acquired pneumonia (HAP). These therapies not only represent the forefront of scientific advancement but also reflect modern medicine’s ongoing pursuit of precision and personalized treatment. 1. Nipocalimab-aahuNipocalimab-aahu (brand name: IMAAVY), developed by Janssen Biotech, a subsidiary of Johnson & Johnson, is a humanized monoclonal antibody targeting the neonatal Fc receptor (FcRn) for the treatment of generalized myasthenia gravis (gMG). It received its first approval in the United States on April 29, 2025, for this indication. Nipocalimab is an IgG1 monoclonal antibody that selectively binds to and inhibits the interaction between FcRn and IgG, thereby accelerating the degradation of pathogenic IgG antibodies and reducing their concentration in the bloodstream. Under physiological conditions, FcRn binds to the Fc region of IgG, protecting it from lysosomal degradation and prolonging its half-life. However, in autoimmune diseases, this mechanism contributes to the persistence and accumulation of pathogenic IgG. By competitively binding to FcRn, nipocalimab prevents this interaction, leading to the lysosomal degradation of IgG. This targeted mechanism is especially well-suited for diseases driven by IgG-mediated pathogenesis, such as generalized myasthenia gravis and warm autoimmune hemolytic anemia. Compared to traditional immunosuppressants or intravenous immunoglobulin (IVIG), nipocalimab offers effective reduction of pathogenic antibody load without broad immunosuppression, thus providing better safety and tolerability. In pivotal clinical trials for gMG, nipocalimab demonstrated significant clinical improvement, particularly in muscle function scores and reduction in exacerbation frequency, outperforming placebo. The treatment showed a rapid onset and durable efficacy. Additionally, its subcutaneous route of administration enhances patient adherence. Even after its approval, Johnson & Johnson plans to continue long-term follow-up studies to assess real-world safety and effectiveness, as well as explore broader applications in other rare autoimmune conditions. Currently, there are several therapeutic options available for gMG and other IgG-mediated autoimmune diseases, including corticosteroids, immunosuppressants, IVIG, plasma exchange, and newer targeted biologics. For instance, Argenx’s efgartigimod, a recombinant FcRn-targeting fusion protein, has been approved in multiple countries for gMG. While it shares a similar mechanism with nipocalimab, it is not antibody-based. Nipocalimab, as a monoclonal antibody, may offer stronger binding affinity and longer half-life, potentially making it more suitable for long-term maintenance therapy. Other competitors include Soliris (eculizumab) from Alexion and Rituxan (rituximab), which work via complement inhibition and B cell depletion, respectively, but are costly and require frequent infusions. 2. Prademagene zamikeracelPrademagene zamikeracel (EB-101), developed by Abeona Therapeutics, is a gene therapy approved on April 29, 2025, in the United States for the treatment of dystrophic epidermolysis bullosa (DEB). Prademagene zamikeracel is designed to restore the expression of type VII collagen (COL7) by delivering a functional COL7A1 gene to the patient’s own keratinocytes. DEB is a genetic disorder caused by mutations in the COL7A1 gene, leading to insufficient COL7 production and resulting in extremely fragile skin prone to blistering and wounds. This gene therapy uses a retroviral vector to transfer the functional COL7A1 gene into autologous keratinocytes, enabling these cells to synthesize and secrete normal COL7, which is essential for anchoring fibrils that maintain dermal-epidermal cohesion. The therapy employs a modified retroviral vector that efficiently integrates the gene into the host genome, ensuring long-term and stable gene expression. Its specificity and safety are further enhanced by targeting only the affected skin cells, minimizing off-target effects on other tissues or organs. Clinical studies have shown that Prademagene zamikeracel significantly improves wound healing and reduces blister formation, thereby enhancing patients' quality of life, without evidence of serious adverse effects or drug interactions. Abeona Therapeutics has employed advanced gene-editing technologies and manufacturing processes to ensure drug stability and bioavailability. Pharmacokinetic studies suggest that its efficacy is comparable or even superior to other gene therapies in development. Post-approval, the company continues to monitor the therapy closely, collecting additional clinical data to optimize its formulation and usage guidelines. A Phase IV clinical trial is planned to explore new indications and long-term outcomes. Preliminary findings suggest potential applicability in other types of inherited skin disorders. Currently, most treatments for DEB focus on supportive care, such as wound management, infection control, and pain relief, which do not address the underlying genetic cause. In contrast, Prademagene zamikeracel offers a curative approach by directly correcting the disease-causing gene mutation. Competing therapies include beremagene geperpavec (B-VEC) by Krystal Biotech, a gene therapy based on a herpes simplex virus (HSV) vector platform. Although both therapies aim at gene correction, they differ in their vector systems and gene delivery mechanisms. 3. Penpulimab*Penpulimab, developed by Akeso Biopharma Co., Ltd. (Zhongshan, China), was approved by the U.S. FDA on April 23, 2025, under the brand name AK105. It is indicated for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC) in adult patients who have failed prior first-line therapy. As a fully humanized IgG1 PD-1 monoclonal antibody, Penpulimab features unique structural optimizations and potentially improved safety characteristics. Penpulimab is a fully human IgG1 subtype monoclonal antibody targeting programmed cell death protein 1 (PD-1). Its mechanism of action centers on modulating T-cell–mediated anti-tumor immune responses. PD-1 is an immune checkpoint molecule expressed on activated T cells; when bound to its ligands (PD-L1/PD-L2), it inhibits T-cell activity, allowing tumors to evade immune surveillance. Penpulimab binds with high affinity to PD-1, blocking its interaction with PD-L1/PD-L2 and restoring the immune system’s ability to recognize and destroy tumor cells. Unlike many other PD-1 antibodies that use the IgG4 subtype, Penpulimab adopts an IgG1 framework, which enables a stronger antibody-dependent cellular cytotoxicity (ADCC) effect, potentially enhancing immune clearance within the tumor microenvironment. Additionally, the Fc region of Penpulimab has been engineered to reduce undesired immune activation, aiming to improve efficacy while minimizing immune-related adverse events. Penpulimab’s development has focused on nasopharyngeal carcinoma, a malignancy with high prevalence in China and other parts of Asia. In pivotal Phase II clinical trials, Penpulimab demonstrated a notable objective response rate (ORR) and durable disease control in PD-L1–positive patients, with especially pronounced efficacy in Epstein-Barr virus–associated NPC. Data showed that more than 30% of patients achieved tumor reduction, with many experiencing long-lasting responses, and some even achieving complete remission. The FDA approval was granted under Priority Review, recognizing Penpulimab’s clear clinical value in treating this difficult-to-manage cancer. Akeso employed a precision medicine approach in its clinical development by focusing on PD-L1–positive and previously treated advanced NPC patients, thereby improving response rates and optimizing the risk-benefit profile—reflecting the current trend toward individualized cancer immunotherapy. Currently, several blockbuster PD-1/PD-L1 inhibitors—such as Keytruda (pembrolizumab, Merck), Opdivo (nivolumab, Bristol Myers Squibb), and Tecentriq (atezolizumab, Roche)—have been approved for various solid tumors, including melanoma, non-small cell lung cancer, and head and neck squamous cell carcinoma. Some studies have explored their use in NPC. However, Penpulimab is the first PD-1 inhibitor formally approved by the FDA specifically for nasopharyngeal carcinoma, filling a critical gap in treatment. While other PD-1 inhibitors may be used off-label in clinical practice for NPC, they have not yet received regulatory approval for this specific indication. 4. LinvoseltamabLinvoseltamab (brand name: Lynozyfic), developed by Regeneron Pharmaceuticals, is a bispecific T-cell engager approved on April 23, 2025, in the European Union, Iceland, Liechtenstein, and Norway for the treatment of relapsed or refractory multiple myeloma (RRMM). Linvoseltamab is a bispecific antibody targeting both B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T cells. It works by simultaneously binding to BCMA-expressing tumor cells and CD3-positive T cells, effectively forming a bridge between them. This interaction leads to the formation of an immunological synapse, activating T cells to release cytotoxic molecules such as perforin and granzymes, which induce direct tumor cell lysis. Beyond cell killing, this bispecific engagement enhances T-cell activation, proliferation, and persistence—amplifying the overall anti-tumor immune response. Unlike conventional monoclonal antibodies, Linvoseltamab does not rely on endogenous antigen presentation to activate T cells. Its ability to directly stimulate T cells gives it a significant therapeutic advantage in targeting BCMA-positive myeloma cells. Preclinical and clinical data have shown that Linvoseltamab not only suppresses tumor growth but also reduces the risk of relapse, offering a novel and promising treatment strategy for patients with advanced myeloma. Clinical studies have demonstrated Linvoseltamab’s efficacy in alleviating symptoms, prolonging progression-free survival (PFS) and overall survival (OS), and significantly improving quality of life, with no major adverse events or drug interactions reported. Regeneron has applied advanced bispecific antibody design and manufacturing technologies to ensure drug stability, bioavailability, and consistent pharmacokinetic profiles. Post-marketing, the company is continuing real-world monitoring, collecting further clinical data to optimize formulation and usage, and plans to initiate Phase IV trials to investigate additional indications and long-term benefits. Preliminary research suggests potential activity against other BCMA-positive hematologic malignancies as well. In the current treatment landscape for RRMM, a variety of therapeutic modalities are available, including monoclonal antibodies, CAR-T cell therapies, and targeted small molecules. For example, Darzalex (daratumumab, Johnson & Johnson) and Blenrep (belantamab mafodotin, GSK) are widely used monoclonal antibodies that target CD38 and BCMA, respectively. While effective, these agents often require combination regimens to maximize their benefit. In contrast, Linvoseltamab as a bispecific T-cell engager offers a standalone, efficient, and simplified treatment approach by directly activating T cells without the need for additional immunomodulatory agents. Other competitors include Abecma (idecabtagene vicleucel) from bluebird bio, a CAR-T therapy targeting BCMA, which has been approved for relapsed or refractory multiple myeloma. Despite their efficacy, CAR-T therapies are complex and costly, making Linvoseltamab a potentially more accessible and scalable option in this therapeutic area. 5. EbdarokimabEbdarokimab (AK-101), developed by Akeso Biopharma Co., Ltd., is a monoclonal antibody approved in China on April 15, 2025, for the treatment of plaque psoriasis. Ebdarokimab is a monoclonal antibody specifically targeting the IL-17A/F heterodimer, functioning by binding to and inhibiting this heterodimer to suppress inflammatory responses and prevent tissue damage. IL-17A and IL-17F are pro-inflammatory cytokines that can act individually or as a heterodimer, activating multiple cell types such as keratinocytes, fibroblasts, and endothelial cells. This activation triggers a cascade of inflammatory responses contributing to the pathogenesis of psoriasis and other autoimmune diseases. By binding to the IL-17A/F heterodimer and blocking its interaction with receptors, Ebdarokimab disrupts downstream signaling pathways, reduces the release of inflammatory mediators, and inhibits cell proliferation—thereby alleviating inflammation at affected sites. This targeted mechanism against the heterodimer offers more comprehensive symptom control and potentially fewer side effects. Moreover, studies suggest that the IL-17A/F heterodimer plays a critical role in ulcerative colitis, providing a theoretical foundation for the potential use of Ebdarokimab in other immune-related diseases. Clinical data show that Ebdarokimab significantly improves skin lesion scores (e.g., PASI scores), and reduces symptoms such as erythema and scaling, markedly enhancing patient quality of life, with no serious adverse reactions or drug interactions observed. Akeso has employed advanced monoclonal antibody production technologies and process optimization to ensure product stability and bioavailability, and pharmacokinetic studies have demonstrated comparable or superior efficacy to similar agents. Even after approval, the company continues post-marketing surveillance and plans Phase IV clinical trials to explore additional indications and long-term outcomes. Some research suggests Ebdarokimab may also have therapeutic potential in ulcerative colitis. Currently, the therapeutic landscape for plaque psoriasis includes several important drug classes such as TNF-α inhibitors, IL-17A inhibitors, and other biologics. Cosentyx (secukinumab, Novartis) and Taltz (ixekizumab, Eli Lilly) are widely used IL-17A inhibitors that specifically bind to and neutralize IL-17A to relieve psoriasis symptoms. Although effective, they only target the IL-17A monomer and do not block the IL-17A/F heterodimer. In contrast, Ebdarokimab offers a more comprehensive therapeutic approach by targeting the heterodimer, potentially delivering stronger inflammation control and reducing relapse rates. Other competitors include Stelara (ustekinumab, Johnson & Johnson), an IL-12/23 inhibitor approved for moderate-to-severe plaque psoriasis. 6. Desvenlafaxine BenzoateDesvenlafaxine Benzoate (brand name Desvela, 데스베라서방정), developed by Nexpharm Korea, is a small-molecule antidepressant approved in South Korea on April 9, 2025, for the treatment of major depressive disorder (MDD). Desvenlafaxine Benzoate is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It works by inhibiting the reuptake of serotonin (5-HT) and norepinephrine (NE) into presynaptic neurons, thereby increasing the concentrations of these neurotransmitters in the synaptic cleft, which helps regulate mood and relieve depressive symptoms. By binding to serotonin and norepinephrine transporters, Desvenlafaxine Benzoate prevents their reabsorption into neurons, allowing greater neurotransmitter availability to exert mood-enhancing effects. This dual mechanism of action helps restore neurotransmitter balance in the brain, improving emotional state and reducing symptoms of depression. It also has mild dopamine reuptake inhibition, which may further contribute to its antidepressant efficacy. Compared to other antidepressants, Desvenlafaxine Benzoate demonstrates a favorable dose-response and safety profile, enabling more effective symptom management with fewer side effects. Clinical studies have shown that Desvenlafaxine Benzoate significantly improves depressive symptoms and enhances patient quality of life, while reducing the frequency and severity of depressive episodes. Nexpharm Korea has applied advanced drug design and development technologies to ensure drug stability and bioavailability, and pharmacokinetic studies have confirmed comparable or superior efficacy to similar agents. Post-approval, the company continues to monitor the product, collect clinical data, and refine the formulation and usage guidelines. Plans are in place for Phase IV clinical trials to evaluate additional indications and long-term effectiveness. In the MDD treatment landscape, several major drug classes are used, including selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), and other SNRIs. Notable examples include Pristiq (desvenlafaxine, Pfizer) and Effexor XR (venlafaxine extended-release, Wyeth)—both widely used SNRIs that act through similar mechanisms. Pristiq is known for its good tolerability and relatively low incidence of side effects, while Effexor XR is valued for its broad spectrum of indications. In comparison, Desvenlafaxine Benzoate developed by Nexpharm Korea incorporates a benzoate salt structure, offering enhanced stability and bioavailability, improved efficacy, and reduced side effects. Other competitors include Cymbalta (duloxetine, Eli Lilly), a widely used SNRI for depression and chronic pain management. 7. BARYTHRAXBARYTHRAX (GC-1109), a recombinant anthrax vaccine developed by GC Biopharma, was first approved in South Korea on April 8, 2025, for the prevention of anthrax infection. This recombinant vector-based anthrax vaccine is developed through genetic engineering and is designed to express and deliver the protective antigen (PA) of Bacillus anthracis, stimulating a specific immune response. The vaccine employs recombinant technology to insert the gene encoding the anthrax protective antigen into a viral or bacterial vector. Upon administration, these vectors express and release the PA antigen in the human body, which is then recognized by the host immune system—triggering both humoral and cellular immune responses, generating specific antibodies and memory T cells against Bacillus anthracis. Once the individual is exposed to the pathogen, the primed immune system can rapidly activate, neutralize toxins, and eliminate the bacteria, thus preventing disease onset and progression. Compared to traditional inactivated or live-attenuated vaccines, this recombinant vaccine offers enhanced safety, as it contains no live pathogens and only expresses selected antigenic components, thereby minimizing the risk of adverse reactions. Clinical studies have shown that the vaccine induces high-titer antibody responses, significantly enhancing immunity in subjects without serious adverse events. GC Biopharma applied advanced vector design and manufacturing technologies to ensure the vaccine’s stability and immunogenicity and conducted detailed pharmacokinetic and immunological studies demonstrating that the product provides equal or superior performance compared to existing vaccines. The company continues post-marketing surveillance and plans Phase IV trials to further optimize the formulation, usage guidelines, and explore additional indications and long-term efficacy. Currently, several key vaccine types are available for anthrax prevention, including inactivated, live-attenuated, and recombinant protein vaccines. BioThrax (manufactured by Emergent BioSolutions) is one of the most widely used anthrax vaccines, made from a cell-free extract of Bacillus anthracis PA. Although approved in multiple countries and widely used, BioThrax requires multiple doses and may cause local injection site reactions and mild side effects. In contrast, BARYTHRAX, as a novel recombinant vector vaccine, offers a safer and more effective alternative, potentially requiring fewer doses to establish durable immunity. Competing products include NuThrax (also from Emergent BioSolutions), a next-generation vaccine combining BioThrax with the CpG 7909 adjuvant to enhance the speed and strength of immune responses. 8. Dalnacogene PonparvovecDalnacogene ponparvovec (also known as BBM-H901), developed by Belief BioMed, is an adeno-associated virus (AAV)-based gene therapy approved in China on April 8, 2025, for the treatment of Hemophilia B. Dalnacogene ponparvovec delivers a functional human coagulation factor IX (FIX) gene into liver cells to correct the coagulation deficiency caused by mutations in the FIX gene. Using an AAV vector carrying an optimized FIX gene sequence, the therapy targets hepatocytes after administration, enabling the integration and expression of the FIX gene within the patient’s cells. This leads to sustained production and secretion of functional FIX protein, restoring coagulation ability. The therapy incorporates advanced gene engineering and sequence optimization to produce FIX protein with enhanced activity and stability, significantly improving therapeutic outcomes. Unlike traditional FIX replacement therapies, which require regular infusions, Dalnacogene ponparvovec offers a one-time treatment with long-lasting effects, reducing treatment burden and improving quality of life. Clinical studies have demonstrated that Dalnacogene ponparvovec significantly increases FIX protein levels and reduces bleeding episodes, leading to marked improvements in patients' coagulation function and overall well-being. Belief BioMed has employed cutting-edge AAV vector design and manufacturing technology to ensure product stability and bioavailability, and pharmacokinetic studies confirm comparable or superior efficacy to other gene therapies. Post-approval, the company is maintaining ongoing safety monitoring, gathering additional real-world data, and planning Phase IV clinical trials to explore broader indications and long-term benefits. Preliminary studies suggest the therapy may have potential in treating other inherited disorders. In the treatment landscape for Hemophilia B, current options include recombinant FIX protein replacement therapies, non-replacement therapies, and other gene therapies. Alprolix (a recombinant FIX-Fc fusion protein by Bioverativ) and BeneFIX (recombinant FIX by Pfizer) are widely used replacements that supplement exogenous FIX to correct coagulation deficits but require frequent infusions, which can be inconvenient. By contrast, Dalnacogene ponparvovec, as a single-administration AAV-based gene therapy, offers a long-term solution with sustained FIX expression and reduced treatment frequency. Other competitors include Valoctocogene roxaparvovec (BioMarin), an AAV gene therapy for Hemophilia A. Although targeting a different clotting factor, its clinical development has provided valuable insights applicable to the advancement of Dalnacogene ponparvovec. 9. Sitagliptin Phosphate Hydrate / Empagliflozin L-ProlineSitagliptin Phosphate Hydrate / Empagliflozin L-Proline (brand name: Empamax, 엠파맥스에스정), developed by Chong Kun Dang Pharmaceutical Corp., is a small-molecule combination drug for the treatment of type 2 diabetes mellitus (T2DM). It was first approved in South Korea on April 7, 2025. Sitagliptin phosphate is a dipeptidyl peptidase-4 (DPP-4) inhibitor that works by blocking the enzymatic degradation of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), thereby prolonging the action of these incretin hormones. GLP-1 and GIP enhance insulin secretion and suppress glucagon release, leading to improved glycemic control. Sitagliptin also helps preserve β-cell function and slows the progression of T2DM. Empagliflozin, on the other hand, is a sodium-glucose co-transporter 2 (SGLT2) inhibitor that lowers blood glucose levels by inhibiting glucose reabsorption in the kidneys and increasing urinary glucose excretion. The combination of a DPP-4 inhibitor and an SGLT2 inhibitor offers a dual mechanism of action that not only improves glycemic control but also provides additional cardiovascular and weight management benefits. Empagliflozin promotes weight loss through glucosuria, while sitagliptin preserves β-cell function—making this fixed-dose combination particularly effective for comprehensive T2DM management. Clinical results demonstrate that Sitagliptin Phosphate Hydrate / Empagliflozin L-Proline significantly reduces HbA1c, improves glycemic control, and lowers the incidence of hypoglycemia, while also supporting weight loss. Chong Kun Dang utilized advanced formulation and drug development technologies to ensure the drug’s stability and bioavailability, supported by detailed pharmacokinetic studies showing equal or superior efficacy compared to individual agents. The company continues post-marketing surveillance and plans Phase IV clinical trials to further optimize dosing, explore long-term outcomes, and evaluate additional indications—such as cardiovascular protection, which has been suggested by emerging data. Currently, the T2DM treatment landscape includes various key drug classes such as DPP-4 inhibitors, SGLT2 inhibitors, and other oral hypoglycemic agents. Januvia (Merck) and Jardiance (Boehringer Ingelheim) are two widely used monotherapies that lower blood glucose via different mechanisms. Januvia is known for its tolerability and low risk of hypoglycemia, while Jardiance is favored for its cardiovascular benefits. Compared with these monotherapies, Chong Kun Dang’s fixed-dose combination offers a more comprehensive therapeutic option, especially for patients requiring simultaneous glycemic control and weight management. Competing products include Farxiga (AstraZeneca, an SGLT2 inhibitor) and Trulicity (Eli Lilly, a GLP-1 receptor agonist), both of which use different mechanisms to support glycemic control. 10. AtrasentanAtrasentan, marketed under the brand name Vanrafia, is an innovative small-molecule drug developed by Novartis Pharmaceuticals for the treatment of various kidney diseases. It received its first approval in the United States on April 2, 2025, for the treatment of IgA nephropathy (IgAN). As a selective endothelin receptor antagonist, Atrasentan offers patients a more effective and targeted therapeutic option, with the potential for global adoption to further improve treatment outcomes and quality of life. Atrasentan is a selective endothelin A (ETA) receptor antagonist that functions primarily by blocking the binding of endothelin-1 (ET-1) to the ETA receptor, thereby reducing vasoconstriction and inflammatory responses. ET-1 is a potent vasoconstrictor involved in regulating blood pressure and fluid-electrolyte balance. Under pathological conditions such as kidney disease, ET-1 contributes to excessive vasoconstriction and tissue damage. By selectively antagonizing ETA receptors, Atrasentan significantly lowers intraglomerular hypertension, reduces proteinuria, and helps preserve renal function. Additionally, Atrasentan suppresses the release of inflammatory mediators and mitigates renal fibrosis, thereby slowing disease progression. This dual mechanism of action allows Atrasentan to effectively slow the decline in kidney function and improve long-term outcomes in patients with IgA nephropathy and other glomerular diseases. Clinical studies have demonstrated that Atrasentan excels in reducing proteinuria and preserving renal function, significantly lowering the risk of kidney function deterioration. Novartis applied advanced drug design and development technologies to ensure drug stability and bioavailability, and conducted detailed pharmacokinetic studies, confirming that Atrasentan offers comparable or superior efficacy relative to similar therapies. Even after market launch, the company continues post-marketing surveillance to collect real-world clinical data, with plans to initiate Phase IV clinical trials to explore additional indications and long-term benefits. Notably, current research suggests that Atrasentan may also be effective in treating other glomerular diseases, such as focal segmental glomerulosclerosis (FSGS) and Alport syndrome. Currently, several important drug classes are available for the treatment of IgA nephropathy and other kidney diseases, including but not limited to angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), glucocorticoids, and immunosuppressants. For example, ACE inhibitors and ARBs are widely used to control hypertension and reduce proteinuria, but their mechanisms primarily focus on modulating the renin-angiotensin system, without directly targeting ET-1-mediated pathways. In contrast, Atrasentan, as a selective ETA receptor antagonist, provides a novel therapeutic approach by more effectively addressing glomerular hypertension and inflammatory responses. Other competing therapies include immunosuppressants such as cyclophosphamide and mycophenolate mofetil, which are commonly used to treat severe glomerular diseases but are often associated with significant adverse effects. Conclusion The wave of new drug approvals in April 2025 not only reflects the current advancements in pharmaceutical science and technology but also serves as a critical indicator of the future direction of medical innovation. Increasingly, targeted therapies and biologics are being developed to treat complex and difficult-to-cure diseases. This trend marks the gradual mainstream adoption of personalized medicine, which aims to deliver more effective and less toxic treatments by precisely targeting the key mechanisms of disease pathogenesis. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!

TORONTO, ON / ACCESSWIRE / October 16, 2023 / Intellipharmaceutics International Inc. (OTCQB:IPCIF)(TSX:IPCI) ("Intellipharmaceutics" or the "Company"), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today reported the results of operations for the three and nine months ended August 31, 2023. All dollar amounts referenced herein are in United States dollars unless otherwise noted. We reported that the five nominees, each of whom was an incumbent director of the Company, identified in the Management Information Circular dated August 1, 2023 (the "Circular") were elected as directors of the Company at the annual meeting of shareholders of the Company held September 14, 2023. Other resolutions tabled for consideration at the Meeting, as set out in the Circular, were also approved by shareholders of the Company. On June 5, 2023 the Company filed its annual audited financial statements for the year ended November 30, 2022 as well as the interim (Q1 2023) financial statements, MD&A and the required certifications. The Ontario Securities Commission (the "OSC") was satisfied that the Company had filed the continuous disclosure documents required within the time specified in the failure to trade order (CTO), then in effect, and revoked the CTO June 7, 2023. On March 7, 2023 the Company had announced that the "OSC" had issued a general "failure to file" cease trade order (CTO) pursuant to National Policy 11-103 - Failure to File Cease Trade Orders in Multiple Jurisdictions dated March 6, 2023 in respect of the securities of the Company as a result of the Company's inability to annual audited financial statements and other required filings for the fiscal year ended November 30, 2022 by the filing deadline of February 28, 2023. The CTO prohibited the trading, whether direct or indirect, by any person of any securities of the Company in each jurisdiction in Canada in which the Company is a reporting issuer for as long as the CTO remains in effect; however, the CTO provides an exception for beneficial security holders of the Company who are not (and who were not as of March 6, 2023) insiders or control persons of the Company and who sell securities of the Company acquired before March 6, 2023 if both of the following criteria are met: (i) the sale is made through a "foreign organized regulated market", as defined in section 1.1 of the Universal Market Integrity Rules of the Investment Industry Regulatory Organization of Canada and (ii) the sale is made through an investment dealer registered in a jurisdiction of Canada in accordance with applicable securities legislation. If the default is remedied within 90 days of the date of the CTO (March 6, 2023), including any annual or interim financial statements, MD&A and certifications that subsequently became due, the filing of the documents constitutes the application to revoke the CTO and no application fee would be required. On February 3, 2023 the Company had announced that its annual audited financial statements for the fiscal year ended November 30, 2022, related management's discussion and analysis and accompanying Chief Executive Officer and Chief Financial Officer certificates and annual information form for the fiscal year ended November 30, 2022 due February 28, 2023 will not be filed by the filing deadline. In August 2022 the Company announced that it has entered into a license and supply agreement with Taro Pharmaceuticals Inc. ("Taro"), by which the Company has granted Taro an exclusive license to market, sell and distribute in Canada, Desvenlafaxine Extended-release Tablets in the 50 mg and 100 mg strengths (the "licensed product") approved for sale in the Canadian market by the Pharmaceutical Drugs Directory (PDD) of Health Canada. In February 2022 the Company received marketing approval for the Canadian market from Health Canada (notice of compliance) for generic Pristiq (desvenlafaxine succinate extended-release tablets) in the 50 and 100 mg strengths. Results of Operations The Company recorded net loss for the three months ended August 31, 2023 of $1,889,227 or $0.06 per common share, compared with a net loss of $296,043 or $0.01 per common share for the three months ended August 31, 2022. For the three months ended August 31, 2023, the net loss is attributed to expenditures related to ongoing selling, general and administrative expenses related to professional and legal fees, as well as ongoing R&D expenses, as well as recording of $873,713 as a provision for potential clawback of royalty revenue from future sales of our generic Focalin XR® under the Par agreement; it is connected with licensing revenue of the product during the three-months ended August 31, 2023. In the three months ended August 31, 2022, the net loss was attributed to the gain on sale of equipment, decreased administrative expense related to professional and legal fees and R&D expenses. In the three months ended August 31, 2021, the net loss is attributed to the increase in interest expenses related the accounting for convertible debenture as well as, expenditures related to ongoing selling, general and administrative expenses related to professional and legal fees, as well as ongoing R&D expenses. The Company recorded revenues of $68,718 for the three months ended August 31, 2023 versus $19,068 for the three months ended August 31, 2022. Such revenues consisted primarily of licensing revenues from commercial sales of our generic Focalin XR® under the Par agreement, as well as a milestone payment from the Taro agreement during the three months ended August 31, 2023. Cost of revenue were $873,718 for the three months ended August 31, 2023 in comparison to $Nil the three months ended August 31, 2022. The cost of revenue relates to recording of $873,713 as a provision for potential clawback of royalty revenue from future sales of our generic Focalin XR® under the Par agreement; it is in connection with licensing revenue of the product during the three-months ended August 31, 2023. Expenditures for R&D were $748,216 for the three months ended August 31, 2023 in comparison to $621,591 the three months ended August 31, 2022. The increase in the R&D expenses during the three months ended August 31, 2023 are attributed to the increase in on going R&D expenses. Selling, general and administrative expenses were $193,528 for the three months ended August 31, 2023 in comparison to $(292,296) for the three months ended August 31, 2022, resulting in an increase of $485,824. The increase is due to an increase in administrative costs, and occupancy cost, offset by a decrease in wages. As of August 31, 2023, our cash balance was $400,102. We currently expect to meet our short-term cash requirements from potential revenues for approved generic products or other collaborations, other available financing and by cost savings resulting from reduced R&D activities and staffing levels. Termination of the exclusive licensing agreements for the Company's FDA approved Desvenlafaxine ER, Venlafaxine ER and Quetiapine ER products may provide opportunity for the Company to explore options of supplying the products to multiple sources on non-exclusive bases. However, there can be no assurance that the products previously licensed and terminated will be successfully commercialized and produce significant revenues for us. We will need to obtain additional funding to, among other things, further product commercialization activities and development of our product candidates. The Company recently entered into a license and supply agreement with Taro Pharmaceuticals Inc. by which the Company has granted Taro an exclusive license to market, sell and distribute a product in Canada. There can be no assurance that the product will be successfully commercialized and produce significant revenues for us. Potential sources of capital may include, if conditions permit, equity and/or debt financing, payments from licensing and/or development agreements and/or new strategic partnership agreements. The Company has funded its business activities principally through the issuance of securities, loans from related parties (see "Related Party Transactions" for more information related to the terms of such loans and applicable maturities) and funds from development agreements. There is no certainty that such funding will be available going forward or, if it is, whether it will be sufficient to meet our needs. Our future operations are highly dependent upon our ability to source additional funding to support advancing our product candidate pipeline through continued R&D activities and to expand our operations. Our ultimate success will depend on whether our product candidates are approved by the FDA, Health Canada, or the regulatory authorities of other countries in which our products are proposed to be sold and whether we are able to successfully market our approved products. We cannot be certain that we will receive such regulatory approval for any of our current or future product candidates, that we will reach the level of revenues necessary to achieve and sustain profitability, or that we will secure other capital sources on terms or in amounts sufficient to meet our needs, or at all. There can be no assurance that we will not be required to conduct further studies for our Aximris XR™ product candidate, that the FDA will approve any of our requested abuse-deterrence label claims, that the FDA will meet its deadline for review, or that the FDA will ultimately approve the NDA for the sale of the product candidate in the U.S. market, or that the product will ever be successfully commercialized and produce significant revenue for us. If the Aximris XR™ NDA is approved, there can be no assurance that the Company and Purdue will resolve any potential asserted patent infringement claims relating to the NDA within a thirty (30) day period following the final approval as provided in the stipulated dismissal agreement of the Purdue litigations. There can be no assurance that the Purdue parties will not pursue an infringement claim against the Company again. There can be no assurance that any of our products or product candidates can be successfully commercialized and produce significant revenues for the company. About Intellipharmaceutics Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that can be applied to a wide range of existing and new pharmaceuticals. Intellipharmaceutics has developed several drug delivery systems based on this technology platform, with a pipeline of products (some of which have received FDA approval) in various stages of development. The Company has ANDA and NDA 505(b)(2) drug product candidates in its development pipeline. These include the Company's Oxycodone ER based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System (for which an NDA has been filed with the FDA), and Regabatin™ XR (pregabalin extended-release capsules). Cautionary Statement Regarding Forward-Looking Information Certain statements in this document constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995 and/or "forward-looking information" under the Securities Act (Ontario). These statements include, without limitation, statements expressed or implied regarding our expectations , plans, goals and milestones, status of developments or expenditures relating to our business, plans to fund our current activities, and statements concerning our partnering activities, health regulatory submissions, strategy, future operations, future financial position, future sales, revenues and profitability, projected costs and market penetration and risks or uncertainties arising from the delisting of our shares from Nasdaq and our ability to comply with OTCQB and TSX requirements. In some cases, you can identify forward-looking statements by terminology such as "appear", "unlikely", "target", "may", "will", "should", "expects", "plans", "plans to", "anticipates", "believes", "estimates", "predicts", "confident", "prospects", "potential", "continue", "intends", "look forward", "could", "would", "projected", "goals" ,"set to", "seeking" or the negative of such terms or other comparable terminology. We made a number of assumptions in the preparation of our forward-looking statements. You should not place undue reliance on our forward-looking statements, which are subject to a multitude of known and unknown risks and uncertainties that could cause actual results, future circumstances or events to differ materially from those stated in or implied by the forward-looking statements. Risks, uncertainties and other factors that could affect our actual results include, but are not limited to, , the effects of general economic conditions, securing and maintaining corporate alliances, our estimates regarding our capital requirements, and the effect of capital market conditions and other factors, including the current status of our product development programs, capital availability, the estimated proceeds (and the expected use of any proceeds) we may receive from any offering of our securities, the potential dilutive effects of any future financing, potential liability from and costs of defending pending or future litigation, risks associated with the novel coronavirus (COVID-19) including its impact on our business and operations , our programs regarding research, development and commercialization of our product candidates, the timing of such programs, the timing, costs and uncertainties regarding obtaining regulatory approvals to market our product candidates and the difficulty in predicting the timing and results of any product launches, the timing and amount of profit-share payments from our commercial partners, and the timing and amount of any available investment tax credits, the actual or perceived benefits to users of our drug delivery technologies, products and product candidates as compared to others, our ability to establish and maintain valid and enforceable intellectual property rights in our drug delivery technologies, products and product candidates, the scope of protection provided by intellectual property rights for our drug delivery technologies, products and product candidates, recent and future legal developments in the United States and elsewhere that could make it more difficult and costly for us to obtain regulatory approvals for our product candidates and negatively affect the prices we may charge, increased public awareness and government scrutiny of the problems associated with the potential for abuse of opioid based medications, pursuing growth through international operations could strain our resources, our limited manufacturing, sales, marketing and distribution capability and our reliance on third parties for such, the actual size of the potential markets for any of our products and product candidates compared to our market estimates, our selection and licensing of products and product candidates, our ability to attract distributors and/or commercial partners with the ability to fund patent litigation and with acceptable product development, regulatory and commercialization expertise and the benefits to be derived from such collaborative efforts, sources of revenues and anticipated revenues, including contributions from distributors and commercial partners, product sales, license agreements and other collaborative efforts for the development and commercialization of product candidates, our ability to create an effective direct sales and marketing infrastructure for products we elect to market and sell directly, the rate and degree of market acceptance of our products, delays in product approvals that may be caused by changing regulatory requirements, the difficulty in predicting the timing of regulatory approval and launch of competitive products, the difficulty in predicting the impact of competitive products on sales volume, pricing, rebates and other allowances, the number of competitive product entries, and the nature and extent of any aggressive pricing and rebate activities that may follow, the inability to forecast wholesaler demand and/or wholesaler buying patterns, seasonal fluctuations in the number of prescriptions written for our generic Focalin XR® capsules which may produce substantial fluctuations in revenue, the timing and amount of insurance reimbursement regarding our products, changes in laws and regulations affecting the conditions required by the FDA for approval, testing and labeling of drugs including abuse or overdose deterrent properties, and changes affecting how opioids are regulated and prescribed by physicians, changes in laws and regulations, including Medicare and Medicaid, affecting among other things, pricing and reimbursement of pharmaceutical products, the effect of recent changes in U.S. federal income tax laws, including but not limited to, limitations on the deductibility of business interest, limitations on the use of net operating losses and application of the base erosion minimum tax, on our U.S. corporate income tax burden, the success and pricing of other competing therapies that may become available, our ability to retain and hire qualified employees, the availability and pricing of third-party sourced products and materials, challenges related to the development, commercialization, technology transfer, scale-up, and/or process validation of manufacturing processes for our products or product candidates, the manufacturing capacity of third-party manufacturers that we may use for our products, potential product liability risks, the recoverability of the cost of any pre-launch inventory, should a planned product launch encounter a denial or delay of approval by regulatory bodies, a delay in commercialization, or other potential issues, the successful compliance with FDA, Health Canada and other governmental regulations applicable to us and our third party manufacturers' facilities, products and/or businesses, our reliance on commercial partners, and any future commercial partners, to market and commercialize our products and, if approved, our product candidates, difficulties, delays or changes in the FDA approval process or test criteria for ANDAs and NDAs, challenges in securing final FDA approval for our product candidates, including our oxycodone hydrochloride extended release tablets product candidate, in particular, if a patent infringement suit is filed against us with respect to any particular product candidates (such as in the case of Oxycodone ER), which could delay the FDA's final approval of such product candidates, healthcare reform measures that could hinder or prevent the commercial success of our products and product candidates, the risk that the FDA may not approve requested product labeling for our product candidate(s) having abuse-deterrent properties and targeting common forms of abuse (oral, intra-nasal and intravenous), risks associated with cyber-security and the potential for vulnerability of our digital information or the digital information of a current and/or future drug development or commercialization partner of ours, and risks arising from the ability and willingness of our third-party commercialization partners to provide documentation that may be required to support information on revenues earned by us from those commercialization partners. Additional risks and uncertainties relating to us and our business can be found in the "Risk Factors" section of our latest annual information form, our latest Form 20-F, and our latest Form F-1 and F-3 registration statements (including any documents forming a part thereof or incorporated by reference therein), as amended, as well as in our reports, public disclosure documents and other filings with the securities commissions and other regulatory bodies in Canada and the U.S., which are available on and The forward-looking statements reflect our current views with respect to future events and are based on what we believe are reasonable assumptions as of the date of this document and we disclaim any intention and have no obligation or responsibility, except as required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Trademarks used herein are the property of their respective holders. Unless the context otherwise requires, all references (i) to "we," "us," "our," "Intellipharmaceutics," and the "Company" refer to Intellipharmaceutics International Inc. and its subsidiaries and (ii) in this document to share amounts, per share data, share prices, exercise prices and conversion rates have been adjusted to reflect the effect of the 1-for-10 reverse split which became effective on each of Nasdaq and TSX at the open of market on September 14, 2018. The common shares of the Company are currently traded on the OTCQB and the TSX. Nothing contained in this document should be construed to imply that the results discussed herein will necessarily continue into the future or that any conclusion reached herein will necessarily be indicative of our actual operating results. The consolidated financial statements, accompanying notes to the consolidated financial statements, and Management Discussion and Analysis for the three and nine months ended August 31, 2023 will be accessible on Intellipharmaceutics' website at and will be available on SEDAR. Summary financial tables are provided below. Intellipharmaceutics International Inc. Condensed unaudited interim consolidated balance sheets As at (Stated in U.S. dollars) August 31, November 30, 2023 2022 $ $ Assets Current Cash 400,102 83,722 Trade and other receivables, net - 602 Investment tax credits 268,179 268,179 Prepaid expenses and other assets 193,616 140,008 861,897 492,511 Property and equipment, net 666,132 788,050 Right-of-use asset 37,801 151,471 1,565,830 1,432,032 Liabilities Current Accounts payable 3,859,164 3,764,692 Accrued liabilities 3,517,922 2,821,506 Employee costs payable 3,729,776 3,067,578 Operating lease liability 43,058 165,441 Income tax payable 29,036 29,036 Promissory notes payable 375,252 360,514 Convertible debentures 1,800,000 1,800,000 Deferred revenue 213,730 - Other Liabilities 873,713 - 14,441,651 12,008,767 Shareholders' deficiency Capital stock Authorized Unlimited common shares without par value Unlimited preference shares Issued and outstanding 33,092,665 common shares 49,175,630 49,175,630 (November 30, 2020 - 23,678,105) Additional paid-in capital 45,097,313 45,097,313 Accumulated other comprehensive income 284,421 284,421 Accumulated deficit (107,433,185) (105,134,099) (12,875,821) (10,576,735) Contingencies 1,565,830 1,432,032 Intellipharmaceutics International Inc. Condensed unaudited interim consolidated statements of operations and comprehensive income (loss) For the three and nine months ended August 31, 2023 and 2022 (Stated in U.S. dollars) Three months ended Nine months ended August 31, 2023 August 31, 2022 August 31, 2023 August 31, 2022 $ $ $ $ Revenue Licensing 49,745 - 856,291 16,978 Up-front fees 18,973 19,068 18,973 19,068 Cost of revenue (873,718 ) - (873,718 ) (397,831 ) (805,000 ) 19,068 1,546 (361,785 ) Expenses Research and development 748,216 626,069 1,573,889 1,662,646 Selling, general and administrative 193,528 (292,296 ) 425,867 212,063 Depreciation 40,628 51,478 121,917 154,435 982,372 385,251 2,121,673 2,029,144 Loss from operations (1,787,372 ) (366,183 ) (2,120,127 ) (2,390,929 ) Net foreign exchange gain (loss) (34,965 ) 123,171 (9,421 ) 100,320 Interest income - - - - Interest expense (66,890 ) (53,031 ) (169,538 ) (227,060 ) Financing cost - - - - Other income - - - - Loss on disposal of asset - - - 500,000 Net (loss) income and comprehensive (loss) income (1,889,227 ) (296,043 ) (2,299,086 ) (2,017,669 ) Net (loss) income per common share, basic and diluted (0.06 ) (0.01 ) (0.07 ) (0.07 ) Weighted average number of common shares outstanding basic and diluted 33,092,665 33,092,665 33,092,665 28,213,586 Intellipharmaceutics International Inc. Condensed unaudited interim consolidated statements of cash flows For the three and nine months ended August 31, 2023 and 2022 (Stated in U.S. dollars) Three months ended Nine months ended August 31, 2023 August 31, 2022 August 31, 2023 August 31, 2022 $ $ $ $ Net income (loss) (1,889,227 ) (291,565 ) (2,299,086 ) (2,013,191 ) Items not affecting cash Depreciation 40,628 51,478 121,917 154,435 Accreted interest on convertible debenture - - - 69,351 Gain on disposal of asset - - - (500,000 ) Non-cash lease expense 4,005 (167 ) 8,713 875 Unrealized foreign exchange (gain) loss 7,790 (5,690 ) (2,687 ) (3,878 ) Change in non-cash operating assets & liabilities Trade and other receivables 333,582 - 602 - Prepaid expenses, sundry and other assets (1,205 ) 60,316 (53,608 ) (144,805 ) Accounts payable, accrued liabilities and employee costs payable 1,531,525 (107,518 ) 2,326,799 1,244,917 Deferred Revenue 213,730 - 213,730 - Cash flows provided from (used in) operating activities 240,828 (293,146 ) 316,380 (1,192,296 ) Investing activity Purchase of property and equipment - - - - Sale of property and equipment - - - 500,000 Cash flows provided from investing activities - - - 500,000 Increase (decrease) in cash 240,828 (293,146 ) 316,380 (692,296 ) Cash, beginning of period 159,274 372,795 83,722 771,945 Cash, end of period 400,102 79,649 400,102 79,649 Supplemental cash flow information Interest paid - - - - Taxes paid - - - - CONTACT INFORMATION Company Contact: Intellipharmaceutics International Inc. Isa Odidi Chief Executive Officer 416.798.3001 ext. 102 investors@intellipharmaceutics.com SOURCE: Intellipharmaceutics International Inc. View source version on accesswire.com: