Kalbe International Pte Ltd.

SEOUL, South Korea I October 23, 2023 I Genexine (KQ 095700, CEO Sungjune Hong), a publicly-listed clinical-staged Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, together with PT Kalbe Genexine Biologics (KGbio), a joint venture clinical-stage biotechnology company between Genexine and PT Kalbe Farma that focused on bringing biologics medical innovation to international markets, announced the approval of its long-acting erythropoietin, Efepoetin alfa (GX-E4), by the Indonesian Ministry of Food and Drug Safety (BPOM) for the treatment of chronic kidney disease induced anemia in non-dialysis patients. This milestone marks the first market approval for a drug originating from Genexine's research and development with KGbio. Genexine, in collaboration with KGbio, has been co-developing Efepoetin alfa for CKD patients in both non-dialysis and dialysis settings. While this BPOM approval specifically pertains to the treatment of CKD-induced anemia in non-dialysis patients, it is anticipated that further approvals for dialysis patients with CKD-induced anemia will be secured in due course. Furthermore, a multinational Phase 3 clinical trial targeting dialysis patients is set to commence in the Q4 of 2023, spearheaded by Genexine and KGbio. This study will be conducted across 11 countries in Europe and Asia to facilitate a label expansion including both dialysis and non-dialysis patient populations. “ We are thrilled to have our first-ever product approval ,” said Sungjune Hong, CEO of Genexine. “ This is a landmark result for everyone at Genexine and our partner KGbio and represents our first market approval of therapeutic drugs that have been discovered, developed, and commercialized by a Korean BioPharma company. Our efforts to focus on commercialization over the past year have been successful and we now look to roll out this product in several other Asian countries and expand the indication to include dialysis patients. Efepoetin alfa was one of the products developed using our proprietary hyFc® fusion platform and demonstrates our ability to deliver a novel long-acting EPO drug to patients suffering from CKD-induced anemia .” And President Director of PT Kalbe Genexine Biologics, Sie Djohan said “Kalbe believes by receiving market approval for anemia treatment Efepoetin alfa, It is easier for patients to get access to medicines for their recovery." In 2020, Genexine and KGbio initiated phase 3 clinical trials for non-dialysis patients in a multinational setting, spanning seven countries across Asia and Oceania. These countries included Korea, Australia, Taiwan, as well as Southeast Asian nations such as Indonesia, Malaysia, Thailand, and the Philippines. As of the latest results in April 2023, Efepoetin alfa has demonstrated non-inferiority when compared to Roche's Mircera®, exhibiting a good safety and tolerability profile. It successfully met the primary endpoint, achieving a response rate 69.6% in patients whose hemoglobin levels increased by more than 1g/dL, surpassing the 63.2% for Mircera®. About Efepoetin alfa (GX-E4) Efepoetin alfa (GX-E4) is a bio-better drug for CKD-induced anemia, developed based on hyFc ® , Genexine's proprietary long-acting platform technology. As kidney function declines patients with CKD suffer anemia due to a lack of EPO(Erythropoietin), a hormone that stimulates red blood cell production, approximately 90% of EPO is produced by the kidney. GX-E4 is a long-acting drug that extends the half-life of EPO in the body, that is developed for once every two weeks or once every four weeks injection, compared to the first-generation short-acting EPO product that needs to be injected once every 2 to 3 days. About Genexine Genexine, Inc. is a publicly traded, clinical-stage biotechnology company focused on developing and commercializing immunotherapeutic and next-generation long-acting biologics. Its primary technology platforms are Therapeutic DNA vaccine technology and hyFc® fusion technology. The Company has multiple products in clinical development including several undergoing Phase 3 registration trials. The Company's proprietary pipeline includes GX-188 (tirvalimogene teraplasmid) for cervical cancer, GX-I7 (efineptakin alfa) for multiple cancers, GX-H9 (eftansomatropin alfa) for Pediatric Growth Hormone Deficiency and GX-E4 for CKD-induced anemia, among others. Genexine has established multiple partnerships with global companies in order to expedite product development and commercialization and create significant value. Genexine is listed on the Korean exchange (KOSDAQ: 095700) and is headquartered in Seoul, Korea. Genexine is committed to the well-being and care of patients worldwide. About KGbio KGbio is a clinical-stage biotechnology company established in 2016, focused on bringing biologics medical innovation to markets outside the US/Canada, Western Europe, and China. The business model revolves around in-licensing novel biologics and select biosimilars in oncology and high-specialty therapeutic areas (typically pre-IND or early clinical stage), with the objective to out-license them in target geographies after finishing clinical development as well as regulatory and reimbursement approvals. Platforms of interest include Fc-fusion proteins, antibodies, bi-specifics, ADCs, cell therapies and therapeutic vaccines. The company is backed by Asian pharma companies Kalbe, Genexine and US private equity giant General Atlantic. For more information, kindly visit: https://www.kg-biologics.com/ About Kalbe PT Kalbe Farma Tbk. (“Kalbe”) was established in 1966 and is one of the largest publicly-listed pharmaceutical companies in Southeast Asia. Kalbe has four main divisions managing a broad and strong portfolio of brands; Prescription Pharmaceuticals Division, Consumer Health Division comprising over-the-counter drugs, as well as supplement drink and ready to drink products, Nutritional Division, and Distribution & Logistics Division. Kalbe currently has more than 40 subsidiaries and 14 production facilities with international standards, employed around 16,000 employees and have 72 branches of distribution & logistics across Indonesia. Since 1991, Kalbe’s shares have been listed on the Indonesia Stock Exchange (IDX: KLBF). As of 31 December 2022, Kalbe has IDR 28.9 trillion total consolidated revenue and IDR 98.0 trillion market capitalization. SOURCE: Genexine

HANSIZHUANG's coverage footprint includes 22 emerging market countries across Southeast Asia and MENA KGbio to develop and commercialise HANSIZHUANG in 12 MENA countries; Henlius to receive US$7 million upfront payment plus royalties and up to US$8 million in regulatory milestone payments Henlius is eligible to receive up to US$650 million upon the achievement of sales milestones in the Southeast Asia and MENA SHANGHAI, Sept. 12, 2023 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK) has entered into an exclusive license agreement with PT Kalbe Genexine Biologics ("KGbio"), an Indonesian pharmaceutical company and a holding subsidiary to PT Kalbe Farma, Tbk ("Kalbe"), for the development and commercialisation of HANSIZHUANG (serplulimab injection) as a treatment for two indications including ES-SCLC, Henlius' novel anti-PD-1 mAb, in 12 Middle East and North African (MENA) countries including Saudi Arabia, the United Arab Emirates, Egypt, Qatar, Jordan, Morocco, etc. In 2019, Henlius reached a collaboration agreement with KGbio, upon which KGbio is granted exclusive rights to develop and commercialize HANSIZHUANG in certain therapies in 10 ASEAN member countries. Under the terms of the agreement, Henlius will be responsible for manufacturing and supply and will receive a US$7 million upfront payment, up to US$8 million in regulatory milestones, and royalties from KGbio ranging from 15% to 20% of net sales of HANSIZHUANG in the licensed MENA territory. Henlius will also be eligible to receive up to US$650 million upon the achievement of sales milestones in the licensed 22 countries in Southeast Asia and MENA. "HANSIZHUANG is the first and only anti-PD-1 therapy approved for first-line treatment of small cell lung cancer. More than 30,000 Chinese patients have benefited from its excellent efficacy. We are excited to join forces with KGbio in MENA after the license granted in Southeast Asia," said Jason Zhu, Chief Executive Officer, President, and Chief Financial Officer of Henlius. "Our aim is to continue supporting and improving the treatment outcomes and quality of life for local patients. Through KGbio's commercial network and operational capabilities in MENA, we firmly believe that HANSIZHUANG will bring new hope and health to patients in Southeast Asia and MENA." Ms. Ping Cao, Chief Business Officer, and VP of Business Development of Henlius, said, "The collaboration between Henlius and KGbio since 2019 was driven by a shared vision and mission and has opened a vast potential market for HANSIZHUANG in Southeast Asia. In the past 4 years, both parties have demonstrated a high level of synergistic effect driven by shared objectives. It has laid a strong foundation for our continued collaboration and I'm confident that together, we will continue to achieve more success in MENA." "We welcome the collaboration between KGbio and Henlius. With KGbio's network and operational capabilities in the Middle East and North Africa, this collaboration is an effort for the two companies to develop the products, especially for innovative biological products," said Sie Djohan, President Director of KGbio, who is also the Director of Kalbe, KGbio's holding company. The company's first innovative product, HANSIZHUANG (serplulimab), was approved in China in March 2022. At present, HANSIZHUANG has been approved for 3 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC) and extensive stage small cell lung cancer (ES-SCLC). With its breakthrough efficacy and differentiation advantages in the relevant treatment fields, HANSIZHUANG has earned wide recognitions and its pivotal clinical research results have been published in leading medical journals such as the Journal of the American Medical Association (JAMA). Its synergy with in-house products of the company and innovative therapies are being actively promoted and over 10 clinical trials on immuno-oncology combination therapies are in progress in a wide variety of indications, such as lung cancer, esophageal carcinoma, gastric cancer, etc., covering full range of first-line treatments of lung cancers. As of now, the company has enrolled more than 3,600 subjects globally, and the proportion of White is over 30% in two multi-regional clinical trials (MRCTs). Its global clinical trial data will further support marketing applications in global markets and lay a foundation for clinical application all over the world in the future. In the future, the two companies will fully leverage their respective resources and advantages to promote the commercialisation of HANSIZHUANG in Southeast Asia and MENA. It is anticipated that this will enhance HANSIZHUANG's accessibility in emerging markets and bring high-quality, affordable, and innovative medicines to more patients. About HANSIZHUANG HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC. Up to date, 3 indications are approved for marketing in China, 2 marketing applications are under review in China and the EU, and more than 10 clinical trials are ongoing across the world. HANSIZHUANG was launched in March 2022 and has been approved by the National Medicinal Products Administration (NMPA) for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC). The marketing applications of the first-line treatment for esophageal squamous cell carcinoma (ESCC) and ES-SCLC are under review by the NMPA and the European Medicines Agency (EMA), respectively. Focus on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications. As of now, the company has enrolled more than 3,600 subjects in China, the U.S., Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The results of 3 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA), Nature Medicine, and the British Journal of Cancer, respectively. Furthermore, HANSIZHUANG was recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines Esophageal Cancer, the CSCO Guidelines for Colorectal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours. On the other hand, Serplulimab was granted orphan drug designations by the FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to comparing HANSIZHUANG to standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way. About KGbio KGbio is a clinical-stage biotechnology company established in 2016, focused on bringing biologics medical innovation to markets outside the US/Canada, Western Europe, and China. The business model revolves around in-licensing novel biologics and select biosimilars in oncology and high-specialty therapeutic areas (typically pre-IND or early clinical stage), with the objective to out-license them in target geographies after finishing clinical development as well as regulatory and reimbursement approvals. Platforms of interest include Fc-fusion proteins, antibodies, bispecifics, ADCs, cell therapies and therapeutic vaccines. The company is backed by Asian pharma companies Kalbe Farma, Genexine, and US private equity giant General Atlantic. About Kalbe PT Kalbe Farma Tbk. ("Kalbe") was established in 1966 and is one of the largest publicly-listed pharmaceutical companies in Southeast Asia. Kalbe has four main divisions managing a broad and strong portfolio of brands; Prescription Pharmaceuticals Division, Consumer Health Division comprising over-the-counter drugs, as well as supplement drink and ready to drink products, Nutritionals Division, and Distribution & Logistics Division. Kalbe currently has more than 40 subsidiaries and 14 production facilities with international standards, employed around 16,000 employees and have 72 branches of distribution & logistics across Indonesia. Since 1991, Kalbe's shares have been listed on the Indonesia Stock Exchange (IDX: KLBF). As of 31 December 2022, Kalbe has IDR 28.9 trillion total consolidated revenue and IDR 98.0 trillion market capitalization. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 has been approved for marketing in overseas markets, 18 indications are approved worldwide, and 3 marketing applications have been accepted for review in China, the U.S., and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®, the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. Its NDA for the treatment of esophageal squamous cell carcinoma (ESCC) is under review. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. ​ View original content: SOURCE Henlius Company Codes: HongKong:2696

DUBLIN, June 29, 2022 /PRNewswire/ -- The "South African Cough, Cold and Flu Remedies Industry Landscape Report 2022" report has been added to ResearchAndMarkets.com's offering. Within the local and global Cough, Cold and Flu Remedies markets, the preference for over-the-counter (OTC) medication is spreading amongst consumers, due to the rising costs of healthcare, and the fact that OTC medication is accessible and more cost-effective. Further contributing to this preference is the fact that consumers are increasingly stocking up on OTC Cough, Cold and Flu Remedies in preparation for when they may need it, as well as a boom in e-commerce and home delivery services, which is further supporting the preference for at-home treatment. In terms of the South African market, the local Cough, Cold and Flu Remedies market, which includes Antihistamines/Allergy Remedies, achieved growth of 9.8% year-on-year in retail value terms, between 2020 and 2021. Moreover, the market is predicted to experience robust grow, achieving an estimated 10.4% CAGR until 2026. The report provides a holistic perspective of the Cough, Cold and Flu Remedies market, including the impact of the global COVID-19 pandemic, as well as the potential future impact it will continue to have on the market. In particular, it provides detailed insights into the entire value chain - from manufacturing to retailing, as well as a pricing analysis. Furthermore, the report provides an overview and insights into the latest global and South African market trends, innovation and technology, drivers and challenges, to present an objective insight into the South African Cough, Cold and Flu Remedies market environment and its future. The South African Cough, Cold and Flu Remedies Industry Landscape Report provides a holistic overview of the global and South African market and will help answer the following questions: For the Global Cough, Cold and Flu Remedies Industry Section What are the current market dynamics of the Global Cough, Cold and Flu Remedies industry? Which are the key markets within the Global Cough, Cold and Flu Remedies industry? What are the latest Global Cough, Cold and Flu Remedies industry trends, innovation and technology, drivers, and challenges? For the South African Cough, Cold and Flu Remedies Industry Section What are the current market dynamics (market size, market value, market volumes): 2016-2021 Actual, 2022-2026 Forecasts (including the impact of COVID-19), and distribution channels? What are the latest South African Cough, Cold and Flu Remedies industry trends, innovation and technology, drivers and challenges? For the South African Cough, Cold and Flu Remedies Manufacturer & Distributor Section Which are the key manufacturing and distributor players in the South African Cough, Cold and Flu Remedies industry? For each key player, what is the latest company news in terms of products, services, new launches, and marketing initiatives? Which popular Cough, Cold and Flu Remedies brands and products do the respective companies manufacture/distribute? For the South African Cough, Cold and Flu Remedies Retail and Pricing Analysis Section Which are the key retail players (retail house brands) in the South African Cough, Cold and Flu Remedies industry? What are the prices of popular OTC Cough, Cold and Flu Remedies brands/products across South African retail pharmacies? Key Topics Covered: EXECUTIVE SUMMARY Global Industry Snapshot South African Industry Snapshot South African Industry Drivers and Challenges 1. GLOBAL COUGH, COLD AND FLU REMEDIES INDUSTRY 2. SOUTH AFRICAN COUGH, COLD AND FLU REMEDIES INDUSTRY 3. SOUTH AFRICAN COUGH, COLD AND FLU REMEDIES MANUFACTURER & DISTRIBUTOR OVERVIEW 3.1 Adcock Ingram: Overview 3.2 Adcock Ingram: Cough, Cold and Flu Remedy Brands/Products 3.3 Aspen Pharmacare: Overview 3.4 Aspen Pharmacare: Cough, Cold and Flu Remedy Brands/Products 3.5 Bayer AG: Overview 3.6 Bayer AG: Cough, Cold and Flu Remedy Brands/Products 3.7 Cipla Medpro: Overview 3.8 Cipla Medpro: Cough, Cold and Flu Remedy Brands/Products 3.9 GlaxoSmithKline Plc: Overview 3.10 GlaxoSmithKline Plc: Cough, Cold and Flu Remedy Brands/Products 3.11 iNova Pharmaceuticals: Overview 3.12 iNova Pharmaceuticals: Cough, Cold and Flu Remedy Brands/Products 3.13 Johnson & Johnson: Overview 3.14 Johnson & Johnson: Cough, Cold and Flu Remedy Brands/Products 3.15 Nativa: Overview 3.16 Nativa: Cough, Cold and Flu Remedy Brands/Products 3.17 Novartis: Overview & Cough, Cold and Flu Remedy Brand/Products 3.18 Procter & Gamble: Overview 3.19 Procter & Gamble: Cough, Cold and Flu Remedy Brands/Products 3.20 Reckitt Benckiser: Overview 3.21 Reckitt Benckiser: Cough, Cold and Flu Remedy Brands/Products 3.22 South African Cough, Cold and Flu Remedies Manufacturers & Distributors: Other 4. SOUTH AFRICAN COUGH, COLD AND FLU REMEDIES RETAIL & PRICING ANALYSIS 4.1 South African Cough, Cold and Flu Remedies Retail Overview 4.2 South African Cough, Cold and Flu Remedies Pricing Analysis Companies Mentioned Adcock Ingram Aspen Pharmacare Bayer AG Cipla Medpro GlaxoSmithKline (GSK) Plc iNova Pharmaceuticals Johnson & Johnson Nativa Novartis Procter & Gamble (P&G) Reckitt ACDOCO SA Ascendis Health Austell Brunel Laboratoria Clippa Sales DB Pharmaceuticals Kalbe International Mondelez International Pharma Dynamics SA Natural Products For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. 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