-Supplying 'WINUF Central 736·1085ml' through Mongolian pharmaceutical company AsiaPharma LLC-First WINUF export in the Asia region, with expectations of expanding exports to other countries November 2023 JW Holdings has announced that it will officially start exporting the Total Parenteral Nutrition 'WINUF Central 736·1085ml' (hereafter, WINUF) to AsiaPharma LLC in Mongolia. JW Holdings, responsible for JW Group's global business, signed an exclusive supply agreement for WINUF in the Mongolian market with AsiaPharma LLC in December 2021. AsiaPharma LLC is a top local pharmaceutical company in Mongolia established in 2001 with extensive experience for 21 years and specialized in distributing parenteral nutrient solutions. AsiaPharma LLC received product approval for WINUF from the Mongolian Ministry of Health in December last year and officially entered local sales starting this month. WINUF is a total parenteral nutrition developed by JW Life Science. It separates one container into three chambers to easily mix essential nutrients, including four types of lipids, amino acids, glucose, and fish oil. It is characterized by its high content of Omega-3 and Omega-6, which promote immune system enhancement and recovery more effectively than single nutrient solutions. In the domestic market, JW Pharmaceutical is responsible for its sales. Since its release in 2013, it has maintained the top position in the total parenteral nutrient solution market. This is the first time that JW Holdings is exporting WINUF to the Asian market. With the export of WINUF to Mongolia, the company expects to gain momentum for exports to other Asian countries. A representative of JW Holdings stated, "JW's product development and production competitiveness for high-value total parenteral nutrient solutions have been recognized in the global market." They added, "Now that WINUF has taken its first step into Asian countries, we will further strengthen our position as a global nutrition company by expanding to more countries." Meanwhile, JW Life Science, an affiliate of JW Holdings, completed the expansion of the automated production facility 'TPN 3 Chamber' for domestic exclusive-volume total parenteral nutrient solutions in its production facility located in Dangjin, Chungcheongnam-do in October last year. With the full operation of 'TPN 3 Line,' the annual maximum production capacity of JW Life Science's total parenteral nutrient solutions has increased by 37% from the previous 10.2 million units to 14 million units. The annual maximum production capacity for all intravenous solutions, including total parenteral nutrient solutions, has become the largest in South Korea, totaling 180 million units.

-Wnt pathway activation via GFRA1 receptor binding is a key action mechanism of hair regeneration…First reported case of synthetic small molecule-The excellent efficacy to growth in hair shaft and hair follicles was confirmed…Verification of equivalent or higher effects compared to the standard of care drug 2022. 11 JW Pharmaceutical announced on the 21st that JW researchers unveiled action mechanism of the newly identified Wnt-modulating small molecule, "JW0061" and demonstrated preclinical efficacy for hair regeneration at the "Wnt 2022" conference. The WNT signaling is playing a critical role in the differentiation of skin stem cells into hair follicles. In particular, Dermal Papilla (DP) cells as a dermal organizing center are well known for providing inductive signals to promote growth and differentiation of surrounding cells during hair growth, which mainly relies on an intracellular WNT signaling. JW0061 is a first-in-class drug candidate that promotes hair regeneration by activating the Wnt pathway in skin and hair follicle stem cells. According to the preclinical data, JW0061 activates the Wnt signaling pathway by directly binding to the GFRA1 protein in the dermal papilla cells. JW researchers further demonstrated that JW0061 induces anagen phase in hair growth cycle and hair regeneration that are highly correlated with WNT activation in various efficacy models. In detail, the hair growth cycle is made up of three phases: anagen, catagen and telogen. The anagen is also referred to as the active phase of hair growth whose defects mostly cause hair loss. JW0061 was shown to make the entry of anagen earlier by more than 15 days, which takes 50 days on average in mice, and be efficacious to growth in hair shaft and new hair follicles in 34 days after application, which are comparable to or higher than that of the standard of care (SoC) drug. Moreover, the combination therapy of JW0061 with the SoC drug synergized the maximum hair growth effect.  JW Pharmaceutical plans to develop JW0061 as a new topical drug supplementing and replacing existing hair loss treatments in the future. Currently, GLP toxicological evaluation is being conducted, aiming at a clinical trial of JW0061 in the first half of 2024, and collaboration research is also underway with a key opinion leader in dermatology field in the USA. Chan-hee Park, chief technology officer (CTO) of JW Group, said, “Among standard treatments on the market and various clinical trials for androgenic alopecia, there is no drug that clearly identifies the action mechanism of hair growth and its binding target protein.” He also said, “The JW0061 data will draw attention as an innovative drug candidate targeting GFRA1 for hair loss treatments.” Meanwhile, the Wnt international conference has an important objective to bring together various researchers for exchanging cutting-edge information, leading to advance of the Wnt research area. The year of “2022” marks the 40th anniversary of the discovery of the Wnt protein, and the in-person conference was held in Awaji, Japan for the first time in three years after last meeting. Researchers gathered from academia, pharmaceutical and bio companies in Asia, Oceania, the US as well as Europe.◎ Wnt Signaling PathwayVarious studies have shown over the past 40 years that the Wnt signaling pathway exists across all species, from nematodes to mammals, and plays an essential role in cell proliferation and differentiation, organ generation, and morphogenesis. Impeding the Wnt pathway inhibits the formation, proliferation, and metastasis of cancer cells in various tissues. Conversely, the Wnt pathway activation is involved in tissue regeneration through stem cell promotion and cell proliferation. Likewise, the Wnt pathway affects many human diseases, but so far, no new drug is available to control this pathway. ◎JW Pharmaceutical Wnt Targeted First-In-Class R&DJW Pharmaceutical has been focusing on development of new drugs controlling Wnt signaling pathway since the early 2000s. "JWELRY," a data science platform specialized in the Wnt signaling pathway, is being used as a core technology where we screen drug candidates from tens of thousands of compound libraries and conduct mechanism studies associated with Wnt signaling pathway. Currently, various new drug candidates were nominated in the fields of anticancer, regenerative medicine, and immune diseases. In addition, joint research is being conducted by harmonizing domestic and foreign Biotech's AI (Artificial Intelligence) platforms in order to explore new indications of own drug candidates in JW pharmaceutical. ◎ Hair Loss and Treatment MarketHair loss is caused by various causes such as genetic factors, autoimmune diseases, and mental stress, and the number of patients is rapidly increasing. Currently, primary hair loss treatments include Finasteride, Dutasteride, and Minoxidil. Finasteride and Dutasteride are prescribed to male patients, and there is a possibility of on-target side effects. Minoxidil can be prescribed to both male and female patients, and its disadvantages are that the mechanism is unclear and hair loss recurs soon after stopping medication. Altogether, there is a great demand for hair loss treatments which have a clear mechanism of hair growth and can be safely used by both genders. The global market is worth 8 trillion won as of 2020, and the related market is growing by 8% every year. According to Global View Research, a global market research company, it is expected to be worth of 15 trillion won by 2028.

- ‘First in Korea', it has formed a partnership with Venture Capital firm ARCH Venture Partners of U.S. to establish relationships with biotechnology companies and research institutions overseas.- Targeting global open innovation and expanding from medical centers and research institutes to bio companies- Searching for joint research partners and technology concepts in six fields, including pharmaceuticals and biopharmaceuticals, through the ATS program 2022. 7 JW Group announced on the 6th that it has signed a agreement with ARCH Venture Partners, a U.S. venture capitalist (VC), to strengthen the promotion of open innovation strategies with global buyer companies. Under the agreement, JW Group will receive ATS (ARCH Technical Service) programs from ARCH Venture Partners. ATS provides promising technology concepts and biotech information to strategic investors interested in business cooperation with venture companies around the world. ARCH Venture Partners invests in advanced technology companies and is one of the largest early-stage technology venture firms in the United States. The firm is a recognized leader in commercializing technologies developed at academic institutions, corporate research groups and national laboratories. ARCH invests primarily in companies it co-founds with leading scientists and entrepreneurs, bringing innovations in life sciences and physical sciences to market. ARCH recently announced the closing of ARCH Venture Fund XII, with $2.975 billion to invest in the creation, development and funding of early stage biotechnology companies. This is the first time ever that a domestic pharmaceutical company has joined hands for open innovation in the field of basic research (discovery stage) with a VC specializing in bio and healthcare in the U.S. JW Group is planning to expand its open innovation partners to global bio companies by utilizing ATS programs. Until now, overseas open innovation targets have been centered on hospitals, medical schools, and research institutes. JW Group plans to search for joint research partners regarding △Synthetic molecules (Small Molecule) △Biologics △New modality △ Data science (AI/ML) △ Medical devices △ Nutrition in consideration of each company's R&D areas such as, JW Pharmaceuticals, C&C Research Laboratories, JW Life Sciences, JW Bioscience, JW CreaGene, etc. Keith L. Crandell, co-founder of ARCH Venture Partners, said “ARCH Technical Services (ATS) is an ARCH Venture Partners, program for Strategic Investors that enables the strategic groups to successfully build their venture and business development practice around the world, By working with JW as part of this program we hope to enable the success of such efforts with JW and build a strong relationship” Chan-Hee Park, CTO (Chief Technology Officer) of JW Group said, "JW aims to build a sustainable cooperation model that creates synergy by combining it with its own platform and to create R&D results." He also said, "We will achieve successful open innovation results by cooperating with ARCH Venture Partners and discovering leading biotech technologies overseas.” Meanwhile, JW Group is focusing on generating profits, establishing research organizations, and securing differentiated technology based on the specialized business structure of each affiliate. It is focusing on developing new global innovative drugs, developing IV fluids technologies and improving services, and developing advanced precision in vitro diagnostic devices. In particular, JW Pharmaceutical is promoting an open innovation strategy in order to expand a new modality for new drug candidates under development. This is to secure the next-generation new innovative drug pipeline by combining JW's own R&D platform (JWELRY, CLOVER) and promising bio companies' R&D platform.

- LEO Pharma enrolls the first patient for JW1601 phase 2b clinical trial in Europe∙North America∙Japan∙Australia- Oral type histamine H4 receptor antagonist that suppresses itching and inflammation 2021. 12. 15 The potential new atopic dermatitis drug that was licensed out by JW Pharmaceutical to Denmark-based LEO Pharma, a leader in medical dermatology, is entering global phase 2b dose-ranging clinical trial. According to JW Pharmaceutical, LEO Pharma has announced on the 15th that they have enrolled the first patient in a phase 2b clinical trial of JW1601 for the potential treatment of moderate-to-severe atopic dermatitis (LEO Pharma project name : LEO 152020). JW1601 is a new drug candidate for moderate-to-severe atopic dermatitis that was licensed out at a value of 402 million dollars at the preclinical stage by JW Pharmaceutical to LEO Pharma in 2018. JW1601, which is being developed as an oral dosage form, is believed to have a dual-action mechanism that selectively acts on the histamine H4 receptors to suppress inflammation and itching. Histamine is a major mediator for allergic inflammation. The H4 receptor, unlike the H1-H3 receptors, induces itching when combined with histamine, and controls the activation and movement of immunocytes that cause atopic dermatitis. This clinical trial is targeted at adults suffering from moderate-to-severe atopic dermatitis, and after 16 weeks of treatment, the JW1601 group will be compared with placebo group to evaluate efficacy and safety. The primary endpoint of this trial is the change in (Eczema Area and Severity Index (EASI) from baseline to Week 16. The EASI is a validated scale used globally to assess severity of atopic dermatitis in clinical trials. LEO Pharma has completed the trial for evaluating food effects based on the data from the phase 1 clinical trial performed by JW Pharmaceutical and is initiating the phase 2b clinical trial. The clinical trial will be conducted in in Europe, North America, Japan, and Australia. Dr. Jörg Möller, Executive Vice President of Global Research and Development at LEO Pharma, has said that “We have been encouraged by results on itch in pre-clinical studies with this investigational medicine for patients who prefer oral treatment options,” and that “We are committed to developing innovative therapies that may help improve the lives of patients who need a wider range of treatment options and routes of administration for skin diseases.” JW Pharmaceutical’s CEO Seongyeol Lee said that “there is confidence in the fact that LEO Pharma, a global leader in medical dermatology, is leading the global clinical development of JW1601”, and that “we will strengthen cooperation with LEO Pharma to ensure the development process stays on the path to success.” 

 On 13th September, JW Bioscience, a subsidiary of JW Life Science, announced that a non-exclusive license agreement for “multi biomarker (CFB and CA19-9)” patent was executed with the Swedish diagnostic company Immunovia AB (Nasdaq Stockholm: IMMNOV). This licensed IP can be used to detect pancreatic cancer at an early stage and JW Bioscience holds a patent for the IP in Korea, US, 21 European countries, China, and Japan. The license agreement grants Immunovia a non-exclusive right to use the patent, and it is expected to strengthen JW Bioscience’s position in the global in-vitro diagnostic market. Through this license agreement Immunovia obtained global commercial rights for CFB and CA19-9. The details and deal size of the license agreement is not disclosed as agreed by both companies. JW Bioscience is pursuing its own development of a complement factor b (CFB) and CA19-9-based early diagnosis kit for pancreatic cancer and expects that it will be an innovative solution to unmet needs as it provides a chance for early detection of pancreatic cancer and increased survival rates through a simple blood test. Eun-Kyung Hahm, CEO of JW Bioscience, said, “This contract is an important milestone for JW’s unique IP position and a recognition of the excellence of JW technology in the global market.” She also added that, “JW will be able to further strengthen its commercial and technological competitiveness through the collaboration with Immunovia.” Immunovia has recently introduced the world’s first laboratory developed test for the early diagnosis of pancreatic cancer in the United States, exclusively available from Immunovia, Inc.  Patrik Dahlen, CEO of Immunovia, said, “We are delighted to enter into this agreement with JW Bioscience that further secures relevant IP for Immunovia. That the licensed biomarkers were discovered by Immunovia and JW Bioscience independently confirms their respective biomarker discovery approach.” He added that, “By entering into this agreement, Immunovia and JW BioScience will also evaluate possibilities for commercial and development collaboration to enable early detection of pancreatic cancer.” The holding company JW Holdings obtained patents in Japan (2018), China and Europe (2019), and US (2020) for early diagnosis of pancreatic cancer. The patent was transferred to JW Bioscience in 2021. About ImmunoviaImmunovia AB is a diagnostic company that is developing and commercializing highly accurate blood tests for the early detection of cancer and autoimmune diseases based on Immunovia’s proprietary test platform called IMMray™. The company was founded in 2007, based on cancer studies and ground-breaking research in the Department of Immuntechnology at Lund University and CREATE Health Cancer Center, Sweden. In 2017, Immunovia, Inc. was established in Marlborough, Massachusetts, USA. The IMMray™ PanCan-d test, the first blood-based test dedicated to the early detection of pancreatic cancer on the market, is offered as a laboratory developed test (LDT) exclusively through Immunovia, Inc.The first product, IMMray™ PanCan-d, is undergoing clinical evaluation in some of the world’s largest clinical studies for high risk groups in pancreatic cancer, PanFAM-1, PanSYM-1 and PanDIA-1.Immunovia’s shares (IMMNOV) are listed on Nasdaq Stockholm. About JW BioscienceJW Bioscience is a company that focuses on R&D of diagnostic reagents and medical devices. The commercialization of high value-added in-vitro diagnostic kits is ongoing based on the original technology in diagnostic fields such as sepsis and pancreatic cancer. In addition, they are developing a ‘Point-of-Care Testing (POCT)’ product that enables simple and quick diagnosis. The company is also a forerunner in the localization of essential medical devices through products developed with its own technology, such as LED surgical lamp and infant incubator.In December 2020, it was incorporated as a subsidiary of JW Life Science within the JW group, a company specialized in the production of infusions. With the stable financial power, JW Life Sciences plans to secure the future growth engines by increasing the R&D investment in diagnostic reagents as well as the high value-added nutritional solutions. JW Life Sciences is listed on the KOSPI as ‘034080’. About Pancreatic cancerEvery day, a thousand people die from pancreatic cancer in the world, and about 7,600 cases occur annually within Korea. In addition, the 5-year relative survival rate is about 12%, which is the lowest among all cancer types, so early diagnosis is the most important in this incurable disease. However, due to the fact that pancreas is surrounded by other organs and the early symptoms of pancreatic cancer hardly appear, early diagnosis is quite challenging. According to a paper on the prediction of cancer deaths in the US reported in the 2021 JAMA Network, pancreatic cancer is expected to become the second leading cause of death among cancer patients by 2040.

 -Fostamatinib is a first-in-class oral spleen tyrosine kinase (SYK) inhibitor, to treat chronic immune thrombocytopenic purpura (ITP), which has a mechanism of action that inhibits platelet destruction.-A new treatment option which is differentiated from existing treatments and expected to improve patient platelet counts. June, 2021 JWP announced on June 28th, 2021 that a licensing agreement had been signed with Kissei Pharmaceutical Co., Ltd. (“Kissei”) to develop and commercialize fostamatinib for the treatment of ITP in Korea. This licensing agreement will enable JW Pharmaceutical Corporation (“JWP”) to develop and commercialize fostamatinib in Korea and to strengthen its hemato-oncology product portfolio. Chronic ITP refers to a condition in which the immune system attacks platelets, which leads to a lower than normal platelet count. Chronic ITP is a rare blood disorder with a high medical need, as it causes easy bruising or bleeding, makes it difficult to stop such bleeding and, in severe cases, cerebral hemorrhage and hematemesis may occur. Fostamatinib is an oral SYK inhibitor that targets the underlying autoimmune cause of ITP in adult patients. Unlike existing treatments which promote platelet production, it is a first-in-class drug with a mechanism of action that inhibits antibody-mediated platelet destruction. Fostamatinib, approved by the US Food and Drug Administration in 2018, is indicated for adult patients with chronic ITP who have had an insufficient response to previous treatment. Fostamatinib is marketed in the United States under the brand name TAVALISSE®.The results of a post-hoc data analysis from the Phase 3 clinical program, presented at the American Society of Hematology (ASH) 2019 Annual Meeting, revealed that a high therapeutic response rate is seen in patients with early-stage disease who received fostamatinib within 1 year of the onset of ITP as second-line therapy after treatment with corticosteroids. In comparison with other oral formulations, fostamatinib exhibits lower drug-drug interactions (DDIs) and food-drug interactions, which suggests that it can be taken with or without food and regardless of the use of most other drugs. In 2018, Kissei gained rights to develop and commercialize fostamatinib in Korea, Japan, China, and Taiwan from Rigel Pharmaceuticals, Inc., located in the United States, who originally developed this drug. Starting with this licensing agreement between JWP and Kissei, JWP will proceed with the development, regulatory approval process, and marketing of fostamatinib in Korea. JWP will seek orphan-drug designation for fostamatinib in Korea in order to provide more treatment opportunities to adult patients with ITP. JWP official commented that, “We secure a novel new drug for an orphan disease area through this licensing agreement” and “We will make every effort to prepare for a smooth marketing approval process to ensure that patients suffering from chronic ITP can receive sufficient treatment.”GlobalData Plc, an UK-based data analytics and consulting company, anticipates that the global ITP market will reach about US$ 1 billion (about KRW 1 trillion) in 2025.  About Kissei Pharmaceutical Co., LtdKissei Pharmaceutical Co., Ltd is a Japanese pharmaceutical company with approximately 70 years of history. It provides unique innovative pharmaceutical products as a drug discovery and R&D-oriented company for patients in the world with a special focus on urology, renal diseases, dialysis, and other therapeutics areas with high unmet medical needs. For more details, please visit https://www.kissei.co.jp/ About Rigel Pharmaceuticals, Inc.,Rigel Pharmaceuticals, Inc., is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic disorders, cancer and rare immune diseases. Rigel's pioneering research focuses on signaling pathways that are critical to disease mechanisms. Rigel is headquartered in South San Francisco, California, U.S.A. For more details, please visit https://www.rigel.com 

-JW Sihwa Plant certified by the U.S. Food and Drug Administration for cGMP-The first U.S. DMF approved of Active Pharmaceutical Ingredient (API) for Penem antibiotics in Korea-Finished Drug manufactured by Gland Pharma in India; and marketing and distribution in the U.S. by Dr. Reddy’s Laboratories-Plans to expand market including Canada and expects API business extend to USD 10 millionSuccessfully completed the entering of ‘Ertapenem injection’, the latest carbabenem antibiotics, by suppling of API which has developed and manufactured by JW Pharmaceuticals for the first time in Korea. JW Pharmaceutical announced on 9th June that ‘Ertapenem for Injection’ using API made with its own technology had been launched in the U.S.This is the first time that the finished drug produced from domestic Carbapenem antibiotics is marketed and sold in the U.S., the largest market in the world. JW Holdings made a supply agreement on Ertapenem API in 2017 with Gland Pharma, India, and JW Pharmaceuticals received cGMP certification on the dedicated facility of Penem antibiotics in Sihwa Plant as well as DMF(Drug Master File) certification on Ertapenem API, accordingly. Gland Pharma developed the finished drug made with Ertapenem API manufactured by Sihwa plant of JW Pharmaceutical and get an approval from the U.S. FDA in March.  Dr. Reddy’s has launched the product in the U.S. market. Ertapenem, which is drawing attention as the next-generation antibiotic of the Carbapenem following penicillin and cephalosporin, is used for intractable infections such as skin tissue infections, pneumonia, urinary tract infections, and acute pelvic infections based on its extensive antibacterial effect and excellent efficacy on resistant bacteria. ‘Ertapenem for Injection’ is a therapeutic equivalent generic version of INVANZ for injection of Merck & Co. JW Holdings, which is in charge of the global business of JW Group, has secured a stable export market by supplying Ertapenem API to Gland Pharma from now on. In addition, it is currently preparing to enter the other overseas markets including Canada along with Gland Pharma and is expected to export more than $10 million of Ertapenem API annually. As entering the biggest and most advanced market, the US, JW Holdings is planning to accelerate its penetration into the global Carbapenem antibiotic market. While JW gets into its stride on advance to the global market for Doripenem which is the latest Carbapenem that succeeded in developing with its own technology independently for the first time in Korea, it is planning to expand the sales of both API and finished drug of Imipeneme and Meropenem, exporting to more than 40 countries including China and Japan. “The first entry in the US market with domestic API in the field of Carbapenem antibiotics which requires high-level of synthetic technology has raised the status of domestic pharmaceutical company and proved JW’s excellent technology” and “we will continue to strengthen cooperation with global partners in order to accelerate our entry into next-generation Carbapenem markets such as Ertapenem and Doripenem” says Sung-Kwon Han, President and CEO of JW Holdings. JW Pharmaceutical has secured global competitiveness by accumulating know-how in the field of Carbapenem antibiotics since early 1990. After succeeding in developing the world’s first generic of Imipeneme in 2004, JW has succeeded in synthesizing its own API of Meropenem, Ertapenem and Doripenem, and became the only company having and manufacturing the full portfolio in Korea. JW Pharmaceutical has an overseas export base with an exclusive plant for API synthesis in Sihwa and a dedicated facility for the finished drug in Dangjin complex. Meanwhile, according to global IQVIA data, the global Carbapenem antibiotic market is approximately over $2 billion in 2020, of which Ertapenem has the market size of $401 million. In the US market, the total sales of Carbapenem antibiotics are $344 million and the ‘Ertapenem for Injection’ is approximately $213 million.  About Gland Pharma Limited(BSE: 543245, NSE: GLAND) : Gland Pharma was established in 1978 in Hyderabad, has grown over the years from a contract manufacturer of small volume liquid parenteral products, to become one of the largest and fastest growing injectable-focused companies, with a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India and other markets. It operates primarily under a business to business (B2B) model and have an excellent track record in the development, manufacturing and marketing of complex injectable. It has a wide range of injectable, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology and ophthalmic solutions and also enjoys the distinction of having pioneered Heparin technology in India. For more information, log on to: www.glandpharma.comAbout Dr. Reddy’s(BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) :Dr. Reddy’s Laboratories Ltd. is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Its major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com.

-JW-2286 is a new first-in-class drug candidate that targets STAT3 involved in cancer cell growth, proliferation and metastasis, and drug tolerance. -A potent anticancer effect of JW-2286 in solid tumor with high unmet medical needs, such as triple-negative breast cancer is anticipated. The results of nonclinical studies will be published for the first time at the AACR Annual Meeting. 2021.3 The results from nonclinical studies of JW-2286 under development as an innovative targeted anticancer drug will be published at the world’s most authoritative conference on cancer research. JW Pharmaceutical announced on March 29, 2021 that the results from nonclinical studies of JW-2286 targeting signal transducer and activator of transcription 3 (STAT3) were selected as a topic for a presentation at the AACR Annual Meeting 2021, which will be hosted by the American Association for Cancer Research (AACR) and held online between April 9 and 14, 2021 (local time). The AACR is a nonprofit organization that focuses on cancer research and has more than 40,000 members (e.g., researchers, health care professionals, and experts in the pharmaceutical and biotechnology industries) from all over the world. Since last year, the AACR Annual Meeting has been held online because of COVID-19.  JW-2286 (Previous Development Code: ST-2286) is a new first-in-class drug candidate with a novel mechanism of action that inhibits STAT3, and it is indicated for the treatment of solid tumors, such as triple-negative breast cancer, gastric cancer, colorectal cancer, etc.  The STAT3 protein is a transcription factor that promotes expression of multiple genes involved in tumor cell growth, proliferation, and metastasis and drug tolerance. Several studies have revealed that the inhibition of STAT3 leads to potent anticancer effects. However, there are no successful cases of the development of anticancer drugs targeting STAT3 in the world up to now. JW Pharmaceutical will release the data obtained from nonclinical studies of JW-2286 at the AACR Annual Meeting for the first time. It was found that JW-2286 exhibits high efficacy and safety against normal cells in different solid carcinomas, where the activity of STAT3 is used as a biomarker based on superior selectivity to STAT3, compared to existing standard therapies. Especially, potent effectiveness of JW-2286 in triple-negative breast cancer will be introduced at the conference.  Triple-negative breast cancer is a kind of breast cancer that is not affected by the receptors of the female sex hormone estrogen and progesterone as well as human epidermal growth factor 2 (HER2). This cancer is an area with high unmet medical needs. The person concerned of JW Pharmaceutical said that STAT3 may be a potential target for cancer treatment because it is overexpressed in diverse cancers, leading to the promotion of cancer growth and metastasis and the inhibition of anticancer immune responses. In addition, the person concerned remarked that the presentation at the AACR Annual Meeting would be a good opportunity to receive a verification of the competitiveness of JW-2286 targeting STAT3. JW Pharmaceutical acquired the rights for all drug candidates targeting STAT3 from JW C&C Research Laboratories, a subsidiary company, in June 2020 and started the commercialization of drug candidates. In December 2020, JW Pharmaceutical concluded a joint research agreement on a STAT3 protein degrader to develop a global anticancer drug with VORONOI, a bio-venture company. This project is aimed at developing the next-generation, first-in-class drug that employed a proteolysis-targeting chimera (PROTAC) protein degrader, a protein degradation technology owned by VORONOI. ※ The additional information about STAT3 is presented in the following website.Source: JW Group Media Channel Content http://www.jw-pharma.co.kr/pharma/ko/board/healthtech_view.jsp?contentsCd=2011031111515534OHXT

-JW Pharmaceutical concluded the final report of a late Phase 2 clinical trial of URC102.-In the Phase 2b clinical trial, URC102 met the primary and secondary endpoints and showed high safety profiles. -JW Pharmaceutical plans to conduct Phase 3 clinical trials and explores global out-licensing opportunities upon completion of Phase 2b clinical trial.  The phase 2b clinical trial of the anti-gout drug URC102 has been successfully completed.    On March 18, 2021, JW Pharmaceutical announced the successful completion of the phase 2b clinical trial of URC102 in Korea, which is expected to be a promising novel drug for the treatment of gout in the global market.  URC102 is a new drug candidate effective in treating gout disease due to hyperuricemia which is characterized by an abnormally high level of uric acid in the blood, and it has a mechanism of action that promotes the excretion of uric acid. In 2019, JW Pharmaceutical licensed the right to develop and commercialize URC102 in China to Nanjing Simcere Dongyuan Pharmaceutical Co., Ltd.    The phase 2b clinical trial of URC102 in Korea was initiated in April 2019 and conducted to evaluate the efficacy and safety and find the optimal dose for 171 Korean patients with gout from 18 major hospitals. In this clinical trial, three URC102-treated groups (3mg, 6mg, and 9mg), placebo group, and reference group treated with Febuxostat 80 mg were included. These drugs were orally administered once daily for 12 weeks.   According to the results of the phase 2b clinical trial, URC102 met all of the primary and secondary endpoints and had high safety and tolerability profiles.     The primary endpoint was the percentage of patients who achieved the serum uric acid level ≤ 6 mg/dL at 4 weeks after treatment, which was 88.89% in the URC102 9 mg group, 71.79% in the URC102 6 mg group, 54.05% in the URC102 3 mg, and 0% in the placebo group, respectively. All of the primary endpoint results in three URC102 groups were statistically significant, compared to those from the placebo group in a dose-dependent manner. In the reference group treated with Febuxostat 80 mg, the percentage of patients who achieved the serum uric acid level ≤ 6 mg/dL at 4 weeks after treatment was 84.21%. The percentage of patients who achieved the serum uric acid level ≤ 5 mg/dL was also similar to the above result in a dose-dependent manner. In primary endpoint, the higher response rate is achieved at high dose of URC102. In all dose groups (URC102 3mg, 6mg, and 9mg), the results at 8 weeks and 12 weeks after treatment also demonstrated a consistent tendency with those at 4 weeks.   In addition, since serious adverse drug reactions (sADR) or risks after treatment were not identified in the URC102 group, URC102 was considered to have the same level of safety and tolerability as placebo.  Henceforward, JW Pharmaceutical will plan phase 3 clinical trials, based on the results from the phase 2b clinical trial and is actively seeking partner for global development and commercialization.  Seoung-Yeol Lee, the CEO of JW Pharmaceutical said, “The number of gout patients is largely increasing, and the unmet needs still remain for safer and more effective treatment.” and “As we ascertained positive results from the phase 2b clinical trial of URC102, we aim to develop URC102 as a promising novel drug for the treatment of gout in the global market”.  ※The additional information, including the number of patients with gout, the Korea and global gout therapeutics market size, and the present status of the existing anti-gout drugs, is presented in the following website. Source: JW Group Media Channel Content http://www.jw-pharma.co.kr/pharma/ko/board/healthtech_view.jsp?contentsCd=201223154834606780N0

 - The first virtual symposium held due to the COVID-19- Will discover partnerships for major new drug candidates such as URC102 and CW291 January of 2021 JW Pharmaceutical will discover strategic partnership such as licensing out at world’s largest pharmaceutical and bio investment symposium. It was announced on the 4th that JJW Pharmaceutical will participate in the ‘2021 JP Morgan Healthcare Conference’ held virtually for four days from the 11th (local time) to introduce research projects through video meetings, and to hold one-to-one partnership consultation and discussion meetings for joint researches with global investment companies including multinational companies. JW Pharmaceutical plans to actively engage in open innovation of candidates for major innovative new drugs developed in-house at this conference. In particular, additional global technology alliance projects will be discussed for the gout treatment ‘URC102’, which was successfully licensed out last year and recognized in the global market. URC102, which was licensed out to China in September of last year, an area attracting attention as a blue ocean in the gout treatment market, entered the development stage for the first time overseas by recently obtaining approval for a clinical trial protocol (phase 1) from the National Medical Products Administration (NMPA) of China. Previously, JW Pharmaceutical successfully completed phase 2a clinical trial in 140 Korean gout patients in Korea, providing high safety and the effect of reducing uric acid levels in the blood. The next phase 2b clinical trial completed the administration of subjects last month and is currently collecting clinical data. JW Pharmaceutical is planning to promote strategic alliance for CWP291, which is being developed not only as a Wnt target anticancer drugs, but also as a treatment for COVID-19 through the strategy of re-creating new drugs. JW Pharmaceutical recently secured the right to own and use the research results of CWP291 in COVID-19 infected animal models from the Korea Research Institute of Bioscience and Biotechnology (KRIBB) and entered the subsequent development stage. As a result of the efficacy evaluation of CWP291 in the ‘Syrian Hamster (golden hamster)’, it showed a high improvement rate in lung lesion and an excellent reduction effect in the amount of virus remaining in the lung tissues (PCR). This can be considered as the result obtained by the GRP78 binding mechanism that CWP291 was identified in the existing phase 1 clinical trial of the target anticancer drug. GRP78 has been reported as a host factor for several single-stranded RNA (ribonucleic acid) viruses, including COVID-19, MERS, Dengue, Zika, and Japanese encephalitis in many academic data. In addition, the latest research status and clinical development strategies for the following drugs will also be explained;  ST-2286, the next-generation target anticancer drug which was introduced from C&C Research Laboratories in June of this year; JW1601, which began researches on eye diseases such as age-related macular degeneration (AMD) and allergic conjunctivitis following atopic dermatitis through a strategy to expand indications last year; CWL080061, a Wnt targeted alopecia treatment.  Sung-Yeol Lee, CEO of JW Pharmaceutical said, “We will discuss open innovation with global partners based on the company’s original technology and various nonclinical and clinical results accumulated in Korea and abroad.” He also added, “High interest in the R&D capabilities of JW, which has been proven through licensing out of JW1601 and URC102, is expected.” Sung-Yeol Lee, CEO of JW Pharmaceutical said, “We will discuss open innovation with global partners based on the company’s original technology and various nonclinical and clinical results accumulated in Korea and abroad.” He also added, “High interest in the R&D capabilities of JW, which has been proven through licensing out of JW1601 and URC102, is expected.”