SEONGNAM, South Korea, May 15, 2026 /PRNewswire/ -- SN BioScience Inc., a clinical-stage biotechnology company based in South Korea, announced today that it has initiated the first patient dosing in its global Phase 1b/2 clinical trial evaluating SNB-101 (API: SN-38), a nanoparticle anticancer agent, in patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC).

This multi-center trial, conducted across sites globally including the United States and Europe, will enroll up to 135 patients. The study is designed in three sequential stages: a Phase 1b dose-escalation phase using a 3+3 design to determine the Maximum Tolerated Dose (MTD) at dose levels of 50–70 mg/m², followed by a two-part Phase 2 consisting of Phase 2a and Phase 2b. Phase 2a will conduct dose optimization to identify the optimal therapeutic dose, after which Phase 2b will proceed with dose expansion at the optimized dose to further evaluate clinical activity across a broader patient population. Across Phase 2, key efficacy endpoints including objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) will be assessed to generate the clinical evidence necessary to support regulatory review process.

The advancement into Phase 2 is supported by encouraging prior Phase 1 results conducted in Korea, in which SNB-101 demonstrated a favorable safety profile with no Grade 3 or higher diarrhea events, a disease control rate (DCR) of 83.3% in high-dose cohorts, and a mean progression-free survival (PFS) of 6.3 months in SCLC patients. These findings compare favorably with outcomes historically reported for currently available later-line treatment options, including Zepzelca® and Topotecan.

Based on its Phase 1 results, SNB-101 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for SCLC. Together with Orphan Drug Designation from the FDA and EMA, these designations reflect that SNB-101 has fully established the regulatory framework necessary to pursue accelerated approval.

As a monotherapy, SNB-101 has demonstrated encouraging clinical activity together with a favorable tolerability profile in previously treated SCLC patients. The company believes these findings support the continued clinical development of SNB-101 as a potential treatment option for patients with relapsed SCLC, particularly in later-line settings where tolerability and efficacy remain an important unmet need.

In parallel with the ongoing monotherapy program, SN BioScience is actively expanding the development of SNB-101 into combination strategies with immunotherapy agents (including anti-PD-1, anti-PD-L1, and DLL3-targeted BiTE® T-cell engager therapies) currently used in standard SCLC treatment. The company has already obtained EMA approval for a clinical study evaluating SNB-101 in combination with one immunotherapy agent and is planning to submit an additional CTA within this year for a separate study involving another immunotherapy combination.

In addition, SN BioScience is pursuing the expansion of SNB-101 into additional solid tumor indications, including gastric and pancreatic cancers, through ongoing collaborations and strategic discussions with global pharmaceutical companies.

SNB-101 is the world's first nanoparticle anticancer drug that has formulated extremely insoluble SN-38 into polymer nanoparticles, which is expected to significantly improve therapeutic efficacy and reduce side effects. It is currently undergoing active clinical development for various solid tumor indications in Korea, Europe, and the U.S.A.

Gastric cancer is classified as an extremely rare disease (with a prevalence <200,000) in the U.S. with a 5-year relative survival rate of only about 36% across all stages. Currently, the standard of care for advanced gastric cancer includes cytotoxic chemotherapy (such as irinotecan and paclitaxel) and targeted therapies like trastuzumab for HER2-positive patients. However, the prognosis for patients with advanced stages remains poor. Many patients eventually develop resistance to these first-line treatments or experience disease progression, leaving them with limited effective therapeutic options. According to SN Bioscience, SNB-101 showed excellent efficacy compared to existing standard of care treatments such as paclitaxel, irinotecan and trastuzumab in gastric cancer animal models.

Orphan drug designation is a program where the US FDA facilitates the development and approval of treatments for rare/incurable or life-threatening diseases. This designation provides the qualified drug developers with various benefits such as exclusive rights for 7 years from the date of marketing approval, tax credits for R&D costs, assistance for clinical trial design for clinical development, exemption from review application fees, and priority review support.

SNB-101 previously received ODDs from the US FDA for small cell lung cancer in July 2023 and pancreatic cancer in February 2024. By receiving an ODD for gastric cancer this time, SN Bioscience expects to gain momentum in indication expansion and clinical development.

About SN BioScience Inc.

SN BioScience is a biotech company established in May 2017. It is a drug delivery system R&D company specialized in anti-cancer drugs and is located in South Korea. SN BioScience was founded by pharmaceutical R&D experts, world-class bio-polymer research professors, and clinical professors. From the beginning of its establishment, it has focused on "commercialization" and has been developing nanoliposomes and nanoparticle drug carriers based on pharmacometrics and pharmacokinetics.

SNB-101

SNB-101 is an anticancer agent that is the world's first nanoparticle formulation of the anticancer drug SN-38. It uses a delivery system sophisticatedly designed via dual nano-micelle technology which is a core platform technology of SN Bioscience. SN-38 is an active metabolite of irinotecan which is gaining attention for its use in antibody-drug conjugates (ADCs) such as Enhertu® and Trodelvy®. Compared to existing irinotecan products, drug resistance and safety have been significantly improved, and based on the animal studies, it is expected to be effective for lung cancer, pancreatic cancer, and stomach cancer, which were not the indications previously.

SNB-101 successfully completed Phase 1 clinical trials in patients with solid tumors (NCT04640480) and received IND approval for Phase 1b/2 from the US FDA in December 2024 for the treatment of small cell lung cancer. Subsequently, a regulatory protocol review is currently underway in Europe for phase 2 trials, which will evaluate both monotherapy and combination therapy in patients with small cell lung cancer.

The Korea Drug Development Fund (KDDF) is a government agency funded by three ministries. It aims to actively fund and provide necessary support for drug development in academia and the pharmaceutical industry.

As Korea's most authoritative national drug development platform, the KDDF is dedicated to advancing innovative drug development projects, spanning the entire process from early discovery to clinical stages.

SNB-101 is a polymeric nanoparticle-based nanoformulation of SN-38, the potent active metabolite of irinotecan, a topoisomerase I inhibitor in the Camptothecin class. Utilizing its proprietary dual nanomicelle platform, the drug is designed to maximize tumor-specific targeting by leveraging the Enhanced Permeability and Retention (EPR) effect, thereby enhancing therapeutic efficacy while minimizing toxicity to healthy tissues.

SNB-101 has already garnered international recognition through multiple regulatory designations as a next-generation anticancer therapy. The U.S. FDA has granted SNB-101 Orphan Drug Designation for both small cell lung cancer (SCLC) and pancreatic cancer, and has also granted Fast Track Designation for SCLC — a regulatory green light to accelerate its development timeline.

SN BioScience is set to launch a multinational Phase 1b/2 clinical trial for patients with extensive-stage small cell lung cancer (ES-SCLC), spanning key sites across South Korea, the United States, and Europe. The study will focus on dose optimization, safety, and efficacy, with particular emphasis on enrolling a racially and ethnically diverse patient population to support early commercialization efforts.

Given the aggressive nature and poor prognosis of this rare cancer, SNB-101 is gaining attention as a potential second- or third-line treatment for patients who have failed existing therapies. Furthermore, the company is exploring combination strategies with immunotherapies to position SNB-101 as a potential first- or second-line standard of care in the future.

"SNB-101 represents our commitment to overcoming the limitations of conventional cancer therapies," said Young-Hwan Park, CEO of SN BioScience. "This national grant will accelerate our global clinical development and solidify SNB-101's position as a next-generation anticancer therapy."

SEOUL, South Korea, Jan. 10, 2025 /PRNewswire/ -- SN BioScience today announced that its lead asset SNB-101 has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) for a Phase 1b/2 clinical trial. This achievement follows the designation of SNB-101 as an orphan drug for small cell lung cancer in 2023 and its Fast Track designation in 2024. With this latest clearance, SNB-101 is rapidly advancing toward early commercialization in the U.S. market. SN BioScience expects to initiate the clinical trials in Q2, 2025.

Validated for ES-SCLC, SNB-101 Eyes 2028 U.S. Market Launch
SN BioScience has revealed details of its Phase 1b/2 clinical trial for SNB-101, targeting patients diagnosed with Extensive Stage Small Cell Lung Cancer (ES-SCLC). The trial will concentrate on dose escalation and optimization to improve both efficacy and safety. Approximately 55 patients will be enrolled, with a focus on reflecting the racial diversity of the U.S. population. Furthermore, the study, aimed at supporting Phase 2 clearance in Europe, will be conducted across South Korea, the U.S., and Europe. Efficacy, safety, and pharmacokinetics will serve as the primary endpoints. Following the dose optimization phase, the company plans to assess SNB-101's efficacy and safety in approximately 100 patients through a single-arm, single-dose, open-label monotherapy study. If the results are positive, SN BioScience targets early U.S. commercialization, with market entry expected as early as 2028.

Small cell lung cancer (SCLC), representing 12-15% of all lung cancer cases, is an aggressive disease with a poor prognosis. Around 70% of patients are diagnosed at an extensive stage, where the cancer has already spread, resulting in a five-year survival rate of less than 7%. Despite these challenging statistics, the SCLC treatment market is expected to grow at a compound annual growth rate (CAGR) of 7-10% from 2023 to 2030, according to Evaluate Pharma, highlighting the urgent need for more effective therapies. In this context, SNB-101 emerges as a highly promising treatment option, offering the potential to significantly improve patient outcomes.

SN BioScience aims to establish its treatment as a second- or third-line option for patients resistant to existing therapies. Ultimately, the company seeks to position the therapy as a first- or second-line standard treatment, potentially in combination with immuno-oncology agents.

About SN BioScience Inc.

Founded in May 2017, SN BioScience is a biotech company specializing in drug delivery systems for cancer therapies. Based in the 2nd Pangyo Techno Valley in Seongnam-si, Gyeonggi-do, Korea, the company was established by experts in pharmaceutical R&D, world-class bio-polymer researchers, and clinical professionals. Since its inception, SN BioScience has focused on the commercialization of innovative technologies, particularly in the development of nanoliposomes and nanoparticle drug carriers, supported by advanced pharmacometrics and pharmacokinetics.

SNB-101

SNB-101 is an innovative anticancer drug, marking the world's first nanoparticle formulation of SN-38, the active metabolite of irinotecan. Utilizing SN BioScience's dual nano-micelle delivery system, SNB-101 overcomes the drug resistance and safety issues seen with traditional treatments. The drug has already been highlighted for its use in drug-antibody conjugates (ADCs) such as Enhertu® and Trodelvy®. Preclinical studies suggest that SNB-101 may also be effective against lung, pancreatic, and stomach cancers, expanding its potential applications in oncology.

SEOUL, South Korea, May 9, 2024 /PRNewswire/ -- SN Bioscience Co. Ltd. (CEO Park Young-hwan) announced on May 7 that the FDA has granted Fast Track Designation for small cell lung cancer (SCLC) for SNB-101 (API: SN-38), a new drug for polymer nanoparticle anticancer under clinical trial. SNB-101 was designated as an orphan drug for small cell lung cancer and pancreatic cancer in July of last year and February of this year, respectively. By receiving fast-track designation this time, it is evaluated that it has laid the groundwork that can be commercialized immediately after completion of phase 2 clinical trials.

Despite a long period of research and development, SCLC still remains a field with high medical unmet needs. Currently, the first-line standard treatment is a combination therapy of cisplatin and etoposide, a classic cytotoxic anticancer drug, and 'clinical trials' are included as second-line treatments in the NCCN guidelines.

Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The Fast Track designation facilitates the interactions with the FDA and allows a rolling review for the submission package so it can be reviewed in each section, rather than waiting until every section of the NDA is completed. Additionally, it may be possible to apply for accelerated approval after the completion of phase 2 clinical trials and priority review immediately after the completion of phase 3 clinical trials when qualified.

SNB-101 is the world's first nanoparticle anticancer drug that has been developed extremely insoluble SN-38 into polymer nanoparticles. The nano micelle technology, a core platform technology of SN Bioscience, has been applied. Preclinical and phase 1 clinical results showed that it significantly reduced digestive system adverse events (nausea, vomiting, diarrhea, etc.) compared to existing anticancer drugs, and especially showed excellent efficacy in patients related to lung cancer through lung targeting. The phase 1 clinical trial has been completed, IND for phase 2 has been approved in Korea, and global clinical trials are scheduled to begin after IND approval for phase 2 in the US and Europe in the second half of this year. Following small cell lung cancer and pancreatic cancer, attempts are being made to expand its indications to other solid cancers such as colon cancer, gastric cancer, and biliary tract cancer, and will be verified through phase 2 clinical trials.

About SN BioScience Inc.

SN BioScience is a biotech company established in May 2017. It is a drug delivery system R&D company specialized in anti-cancer drugs and is located in the 2nd Pangyo Techno Valley in Seongnam-si, Gyeonggi-do, Korea. SN BioScience was founded by pharmaceutical R&D experts, world-class bio-polymer research professors, and clinical professors. From the beginning of its establishment, it has focused on "commercialization" and has been developing nanoliposomes and nanoparticle drug carriers based on pharmacometrics and pharmacokinetics.

[SNB-101]

The development name, SNB-101, is the world's first anticancer drug developed from SN-38 as nanoparticles. SN-38 is an active metabolite of Irinotecan which is gaining attention for its use in drug-antibody conjugates (ADCs) such as Enhertu^® and Trodelvy^®. Tolerability and safety have been dramatically improved compared to existing products, and it is expected to be effective in lung cancer, pancreatic cancer, and gastric cancer, were not the indications before. Scale-up production, the biggest barrier that prevented existing nano-cancer drugs from entering the clinical stage, was successful, and clinical trial products are produced at a facility dedicated to anticancer drugs with EU GMP.

According to SN Bioscience, SNB-101 showed excellent efficacy compared to existing first-line treatments Abraxane® and Onivyde® in pancreatic cancer animal models. Based on this, it has been designated as an orphan drug by the US FDA after application in November last year. Pancreatic cancer is a typical incurable tumor with an extremely low 5-year survival rate, and cytotoxic anticancer drugs such as Abraxane® and Onivyde® are currently used as first-line treatments. This is an area of high medical unmet need with limited second-line treatment option.

Orphan drug designation is a program where the US FDA facilitates the development and approval of treatments for rare/incurable or life-threatening diseases. SNB-101 received an ODD from the US FDA for small cell lung cancer in July last year. By receiving an ODD for pancreatic cancer this time, SN Bioscience expects to gain momentum in indication expansion and clinical development.

Orphan drug designation provides the qualified drug developers with various benefits such as exclusive rights for 7 years from the date of marketing approval, tax credits for R&D costs, assistance for clinical trial design for clinical development, exemption from review application fees, and priority review support.

Meanwhile, SN Bioscience received phase 2 approval in Korea for SNB-101 in November last year, and is preparing for phase 2 in the US and Europe in the second half of this year.

About SN BioScience Inc.

SN BioScience is a biotech company established in May 2017. It is a drug delivery system R&D company specialized in anti-cancer drugs and is located in the 2nd Pangyo Techno Valley in Seongnam-si, Gyeonggi-do, Korea. SN BioScience was founded by pharmaceutical R&D experts, world-class bio-polymer research professors, and clinical professors. From the beginning of its establishment, it has focused on "commercialization" and has been developing nanoliposomes and nanoparticle drug carriers based on pharmacometrics and pharmacokinetics.

SNB-101

SNB-101 is an anticancer agent that is the world's first nanoparticle formulation of the anticancer drug SN-38. It uses a delivery system sophisticatedly designed via dual nano-micelle technology which is a core platform technology of SN Bioscience. SN-38 is an active metabolite of Irinotecan which is gaining attention for its use in drug-antibody conjugates(ADCs) such as  Enhertu® and Trodelvy®. Compared to existing irinotecan products, drug resistance and safety have been significantly improved, and based on the animal studies, it is expected to be effective for lung cancer, pancreatic cancer, and stomach cancer, which were not the indications previously. Scale-up production, the biggest barrier that prevented existing nano-cancer drugs from entering the clinical stage, was successful, and clinical trial products were produced at a facility dedicated to anticancer drugs with EU GMP certification.

- Impressive safety and efficacy for solid cancer patients followed by global clinical study plan

SEOUL, South Korea, Oct. 27, 2023 /PRNewswire/ -- SN Bioscience Co., Ltd. (CEO Younghwan Park) announced the results of the phase 1 clinical study of SNB-101, a nanoparticle anti-cancer new drug pipeline, at ESMO Congress 2023 held in Madrid, Spain from October 20 to 24. This phase 1 clinical study was conducted to evaluate the safety and tolerability of SNB-101 administered to 21 patients with solid tumors in Korea and to determine the recommended dose for phase 2. CHA Bundang Medical Center (Professor Joo-Hang Kim), Catholic University of Korea Seoul ST. Mary's Hospital (Professor Myung A Lee), and Severance Hospital of the Yonsei University (Professor Sun Young Rha) participated in this study.

In this phase 1 clinical study, patients with various solid cancers, such as small cell lung cancer, non-small cell lung cancer, gastric cancer, esophageal cancer, head and neck cancer, and rectal cancer, who failed existing standard therapy were enrolled, and they had previously experienced 1^st to 9^th lines of treatment.

The results of the phase 1 study showed excellent safety in the dosage range (5 to 50 mg/m² as of SN-38) and did not reach the maximum tolerable dose (MTD) even when all the cohorts were consumed. The most common adverse drug reactions were hematological, such as neutropenia, and were well manageable. In particular, diarrhea of grade 3 or higher, a major adverse drug reaction that frequently occurs with irinotecan, a drug with same active moiety, was not observed. Accordingly, it was evaluated to have excellent safety and tolerability compared to the competitive drugs.

In terms of the efficacy evaluation results, out of a total of 21 patients, partial response (PR) was 14.3% (3 patients, small cell lung cancer, non-small cell lung cancer, rectal cancer), and stable disease (SD) was 28.6% (6 patients, small cell lung cancer, non-small cell lung cancer, rectal cancer, head and neck cancer, gastric cancer), and progressive disease (PD) was 57.1% (12 patients). The disease control rate (DCR) of all patients was 42.9%, well demonstrating the characteristics of general cytotoxic anti-cancer drugs. In particular, in the high dose group (40~50mg/m²), the DCR was 83.3%, well indicating dose dependency.

SNB-101 is a polymeric nanoparticle with an average particle size of approximately 100 nm, and in the preclinical studies, its distribution to the lungs was significantly higher than that of the anti-cancer drugs in conventional delivery. That aligns well with the efficacy results in lung-related tumors such as small cell lung cancer and non-small cell lung cancer from preclinical and phase 1 clinical studies. Based on the results, SN Bioscience plans to conduct multinational phase 2 clinical study targeting the small cell lung cancer in 2024.

For small cell lung cancer, which is one of the areas with very high unmet medical needs, cisplatin + etoposide combination is currently used as the first line standard therapy. Second line therapies include lurbinectedin (product name: Zebzelca), which was recently approved as an orphan drug, and topotecan and paclitaxel, which are traditional chemotherapeutic regimen. According to the NCCN (National Comprehensive Cancer Network) guidelines, treatments are so limited that clinical studies are listed as second line treatment options. In preclinical studies, SNB-101 showed superior efficacy over the first line therapies as well as the second line therapies that are approved for small cell lung cancer. The goal of phase 2 clinical study is to show the superiority over competitive drugs as monotherapy and/or combination with immunotherapy, based on which, SN BioScience plans to enter the global market through expedited approval process after completing phase 2 clinical study.

[SNB-101]

SNB-101 is the world's first nano-anti-cancer drug in which the active metabolite (SN-38) of Irinotecan, a commercially available anti-cancer drug, is active ingredient, and is applied with double nanomicelle technology, a core platform technology of SN Bioscience. SNB-101 is expected to secure new indications as it does not require a metabolic step for activation as well as the advantage of directly administering SN-38, an active metabolite. SNB-101 is a polymeric nanoparticle of approximately 100 nm characterized by a high accumulation rate, especially in the lung and tumor tissue, when administered intravenously, and has shown a wide range of efficacy in solid cancers such as small cell lung cancer, gastric cancer, colon cancer, and pancreatic cancer in preclinical studies. In addition, since it shows a synergistic effect even when used in combination with commercially available immune-anti-cancer drugs, targeted anti-cancer drugs, and chemical anti-cancer drugs, the possibility of its development as a combination therapy in the future is also very high. SNB-101 has secured mass production technology, which is one of the barriers to the development of nanomedicines and is being produced as a sterile product by a contract manufacturing organization (CMO) specializing in anti-cancer drugs that has received EU GMP certification. Furthermore, the US FDA has designated SNB-101 for orphan drug on SCLC based on the medical needs and its preclinical outcome.

[SN BioScience Inc.]

SN BioScience was established in May 2017 as a drug delivery system R&D biotech company specialized in anti-cancer drugs and is located in the 2nd Pangyo Techno Valley in Seongnam-si, Gyeonggi-do, Korea. SN BioScience was founded by pharmaceutical R&D experts, world-class bio-polymer research professors, and clinical professors. From the beginning of its establishment, it has been conducting research and development with a focus on "commercialization." Polymer nano-drug delivery technology and albumin nano-drug delivery technology are their key platforms, and it is currently in the stage of expanding its technology to sustained-release liposomes and albumin nanoparticles.

SEONGNAM, South Korea, July 21, 2023 /PRNewswire/ -- SN Bioscience Co. Ltd. (CEO Park Young-hwan) announced on July 19 that the US FDA had granted an orphan drug designation for small cell lung cancer for SNB-101 (API: SN-38), a new polymer nanoparticle drug under development. SNB-101 is the world's first nanoparticle anticancer drug that has been developed extremely insoluble SN-38 into polymer nanoparticles. It has been approved for phase 1 clinical trials in the US (NCT04640480) and Korea, and the IND for phase 2 has been filed after phase 1 clinical trial in Korea.

SNB-101 showed excellent efficacy in animal small cell lung cancer models, and based on this, it has been designated as an orphan drug by the US FDA after application in April and review. Small cell lung cancer accounts for 15-20% of all lung cancers with a very poor prognosis. The current standard treatment (first-line treatment) is classic drugs, Cisplatin + Etoposide. However, as there are very limited options for second-line treatment and others, it is an area with very high medical unmet needs.

Orphan drug designation is a program where the FDA facilitates the development and approval of treatments for rare/incurable or life-threatening diseases. SN Bioscience expects the designation as an orphan drug to accelerate the development of SNB-101, which is being developed as a treatment for orphan drugs including small cell lung cancer.

Orphan drug designation provides the qualified drug developers with various benefits such as exclusive rights for 7 years from the date of marketing approval, tax credits for R&D costs, assistance on clinical trial design for clinical development, exemption from review application fees, and priority review support.

About SN BioScience Inc.

SN BioScience is a biotech company established in May 2017. It is a drug delivery system R&D company specialized in anti-cancer drugs and is located in the 2nd Pangyo Techno Valley in Seongnam-si, Gyeonggi-do, Korea. SN BioScience was founded by pharmaceutical R&D experts, world-class bio-polymer research professors, and clinical professors. From the beginning of its establishment, it has focused on "commercialization" and has been developing nanoliposomes and nanoparticle drug carriers based on pharmacometrics and pharmacokinetics.

SNB-101

SNB-101 is the world's first product to use the active metabolite (SN-38) of Irinotecan as an API, and dual nano-micelle technology which is a core platform technology of SN Bioscience is applied. Compared to existing irinotecan products, drug resistance and safety have been significantly improved, and based on the animal studies, it is expected to be effective for lung cancer, pancreatic cancer, and stomach cancer, which were not previously included as indications. Scale-up production, the biggest barrier that prevented existing nano-cancer drugs from entering the clinical stage, was successful, and clinical trial products were produced at a facility dedicated to anticancer drugs with EU GMP certification.

• First Generic of Abraxane in Korea, World 4th Commercial Scale-Up
• Global tech-transfer expected to US, Japan, and Europe

SEONGNAM, South Korea, Jan. 26, 2023 /PRNewswire/ -- SN BioScience (CEO Park Young-hwan) and Boryeong (CEO Jang Doo-hyun) signed a domestic manufacturing technology transfer and co-development contract for the albumin nanoparticle anticancer drug (code name: SNA-001) developed by SN BioScience for the first time in Korea and the fourth time in the world. Through this contract, Boryeong will have exclusive manufacturing and distribution rights in Korea for "SNA-001." SN BioScience will receive milestones and double-digit royalties according to the development stage. SN BioScience also signed a domestic distribution agreement with Boryeong in February 2021 for SNB-101, a polymer nanoparticle new drug, and expects a variety of cooperations in the field of anticancer drugs in the future.

"SNA-001" is a product that electrostatically binds cytotoxic anticancer drugs to albumin using albumin present in human blood as a drug carrier. Abraxane is a global blockbuster first developed by Abraxis BioScience Inc (acquired by Celgene who became a subsidiary of BMS), with sales of $1.5 billion worldwide in 2020.

Albumin has been studied as a carrier that delivers various drugs into cells through electrostatic or chemical bonds with excellent biocompatibility as about 66,000 Dalton of drug transport protein in the blood. Despite the advantages, there has been challenges in commercial scale-up. Even BMS, the original manufacturer, has gone through global shortages from 2019 to 2021 due to manufacturing/quality issues. Only a few companies around the world, such as Teva, have succeeded in scale-up production to date. Based on the commercial scale-up technology for nanoparticle drugs accumulated through SNB-101 (API: SN-38, firtecan), a nanoparticle anticancer drug that has already entered phase 1, SN BioScience has completed the development of a commercial-scale manufacture process for the Abraxane's generic for the fourth time in the world. SN BioScience developed a superior manufacturing process with a yield of more than 90% and a particle size deviation of less than 7%, which is evaluated as having excellent quality and reproducibility compared to products of competitors with a yield of about 70 to 80%.

SNA-001 showed excellent efficacy in solid cancer animal models in non-clinical studies. In the characterization of the in vivo behavior of nanoparticles, it was suitable for key evaluation indicators such as free and encapsulated drug concentrations and drug accumulation in major organs.

Based on the above, SN BioScience is discussing the technology transfer with global leading pharmaceutical companies in the United States, Japan, and Europe, while on the other hand, it is discovering new indications by applying albumin-based nanoparticle platforms to various anticancer drugs. The company is also planning to file phase 1 IND for two to three new nanoparticle anticancer drugs in the second half of this year.

About SN BioScience Inc

SN BioScience is a biotech company established in May 2017, a drug delivery system R&D company specialized in anti-cancer drugs, and is located in the 2nd Pangyo Techno Valley in Seongnam-si, Gyeonggi-do, Korea. SN BioScience was founded by pharmaceutical R&D experts, world-class bio-polymer research professors, and clinical professors. From the beginning of its establishment, it has been developing nanoliposomes and nanoparticle drug carriers based on drug metrology and pharmacokinetics. The main pipelines include polymeric nanoparticle anticancer drugs (on-going phase I in Korea) and albumin nanoparticle anticancer drugs (phase I IND filed).

About Boryung Co., Ltd

Founded in 1957, Boryeong Co., Ltd. is a top-tier pharmaceutical company in Korea that manufactures and sells drugs for chronic diseases such as hypertension, diabetes, brain disease, and anticancer, with sales of about USD 550 million in 2022. In addition, the company has produced various and successful research results, including Kanarb Tab., a new drug for high blood pressure, and has the highest market share in Korea, especially in the field of anticancer drugs.

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