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SHANGHAI, March 27, 2021 /PRNewswire/ — Henlius (2696.HK) announced the financial results for the year ended 31 December 2020. 2020 marked a meaningful year for Henlius as the Company gathered the pace in commercialization and continued the momentum for innovation. The Company delivered a total revenue of approximately RMB 587.6 million, representing an increase of approximately 546% compared with the year ended 31 December 2019. The overall increase was mainly driven by the sales revenue from the launched products, R&D services provided to customers and license revenue. Up to date, 3 products have been successfully marketed in China, 1 product in the EU, 2 products’ New Drug Applications (NDA) have been accepted in China, underscoring the Company’s mission of bringing affordable and high-quality biologic medicines to patients worldwide. Fully leveraging the experience of biosimilar development and harnessing the power of innovation, 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, laying the solid foundation for a diversified and robust innovation pipeline.

Gathering Pace in Commercialization, Making the Most out of Integrated Value Chain

By the end of 2020, Henlius has launched three products including 汉利康® (HLX01), the first biosimilar approved in China, 汉曲优®/Zercepac® (HLX02), the first self-developed Chinese monoclonal antibody (mAb) approved in both China and Europe and 汉达远® (HLX03), the Company’s first product for the treatment of auto-immune diseases, among which the launch of HLX02 in the EU market brought Henlius one step closer to its globalization.

• HLX01, the first Chinese biosimilar, was approved by the National Medical Products Administration (NMPA) in February 2019 and indicated for non-Hodgkin lymphoma and chronic lymphocytic leukemia. It has benefited more than 30,000 patients ever since its launch. The domestic commercial sales of HLX01 were handled by Jiangsu Fosun, a subsidiary of Fosun Pharma. By the end of 2020, provincial medical insurance access work has been finished in 30 provinces and municipalities. Tendering process has been completed in 28 provinces and municipalities. Nearly 70% of the core hospitals have admitted it. With the approval for new indications and new dosage form of 500mg/50ml/vial, as well as the addition of 2,000L production scale in 2020, it is expected to reach more patients in the future.
• HLX02, indicated for HER2 positive breast cancer and gastric cancer, was successively approved by the European Commission (EC) and the NMPA in July and August 2020. Henlius had made full efforts to penetrate the Chinese market by completing all the provincial medical insurance access work and tendering process in 28 provinces and municipalities, laying a strong foundation for the sales growth. In global market, Henlius joined force with its business partner Accord to actively promote the commercialization of HLX02 in the EU. By the end of 2020, HLX02 had successfully entered a number of top hospitals in the United Kingdom as well as nearly 20 EU countries and regions including Germany, Spain, France, Italy, Ireland, Hungary, etc.
• HLX03 was approved by the NMPA for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis as the first product indicated for auto-immune diseases of the Company. Its successful launch marks the expansion of Henlius’ commercial pipeline into the field of autoimmune diseases as well as the broadening of the target patient scope. Jiangsu Wanbang, a subsidiary of Fosun Pharma, is responsible for the domestic commercial sales of HLX03. Tendering process has been finished in 22 provinces and municipalities.

In addition to the three launched products, Henlius pressed forward with the products to be commercialized in the near future. HLX01 (rituximab injection) indicated for rheumatoid arthritis and HLX04 (bevacizumab injection) were both accepted for NDA review by the NMPA, with the commercial launch expected respectively in Q4 2021 and 2021/the first half of 2022 in China. Looking forward, the Company will further build up a commercialization team of market-leading presence and highly-efficient business model to make biosimilar more affordable and accessible, making the most out of its commercialized products.

Continuing the Momentum for Diversified Innovation

Apart from the above-mentioned biosimilars, Henlius continued its momentum for a diversified innovation. Building upon the accumulated resources and technologies in the field of biologic medicines, Henlius has been unlocking the potential of the candidate targets including HER2、EGFR、PD-L1、c-MET、DR4、S1 Protein of SARS-CoV-2、LAG-3, TROP2 ,etc. Meanwhile, Henlius has built a forward-looking presence in innovative targets, bispecific antibodies as well as the antibody-drug conjugates (ADC). Up to date, 21 products and 2 mAb combination therapies have been approved for more than 30 clinical trials worldwide. More than 20 clinical trials for 10 products and 8 combination therapies have been carried out in various countries and regions, including China, the EU, Australia, Ukraine, the Philippines, Turkey, etc.

Particularly, Henlius built an all-inclusive presence in tumor indications with regards to its core innovative mAb product anti-PD-1 mAb HLX10. Steady progress has been made in the clinical studies of 2 monotherapies and 8 combination therapies with HLX10 (PD-1) as the core for the treatment of MSI-H solid tumors, lung, hepatocellular, esophageal, head and neck, gastric cancers, etc. About 2,000 patients have been enrolled in China, Turkey, Poland, Ukraine, Russia, etc., making HLX10 one of the PD-1 products boasting a large global clinical data pool. Henlius is expected to file the NDA of HLX10 (PD-1) in China at the end of March or in the beginning of April 2021. The NDA filing of HLX10 (PD-1) in combination with chemotherapy for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) indication in China will also be expected in the second half of 2021.

In 2020, Henlius entered into an exclusive license agreement with Chiome from Japan. Chiome agreed to grant Henlius an exclusive right and license to antibodies targeting human TROP2 and related intellectual property rights to research, develop, manufacture and commercialize the licensed product in China (including Hong Kong, Macau and Taiwan China). Its potential is being uncovered with regards to ADC, bispecific antibodies and combination therapies. Henlius was also on a solid growth trajectory to develop COVID-19 candidate drugs in 2020. The Investigational New Drug (IND) applications of HLX71 (ACE2-Fc fusion protein) was approved by the U.S. Food and Drug Administration (FDA). The Company will initiate the clinical studies of HLX71 in the United States in the future.

Breakthroughs in Capacity and Quality Making Affordable Innovation Possible

Breakthroughs in capacity and quality were made by scaling up the production capacity in the three manufacturing facilities and benchmarking against the international quality standards. Xuhui facility has passed the multiple on-site inspections conducted by the NMPA, European Medicines Agency (EMA), EU QP (Qualified Person) and was certificated by China and the EU GMP, laying the solid foundation for the product launch in global market. In terms of capacity, Henlius scaled up its production capacity to 20,000L in Xuhui Facility in 2020. A prefilled needle production line is also planned to be added in 2021 to address the short-term market demand. To further ramp up the capacity, Henlius has also promoted the construction of Songjiang First Plant and Songjiang Second Plant. In 2020, the production capacity of Songjiang First Plant has been increased to 24,000L. For the Phase I project of Songjiang Second Plant, the pile foundation works and structure of the main production buildings have been completed. It is to be completed and put into trial production and subject to relevant verifications in 2021.

Henlius continued to explore the power of advanced production technology such as continuous manufacturing technology. The construction, commission and verification of the pilot workshop had been completed by the end of 2020.

Expanding Global Footprint with Strategic Partners

In 2020, Henlius successively secured partnership with Mabxience and Accord to build market presence of HLX02 in the global major markets. Meanwhile, Henlius joint force with Essex to co-develop its HLX04-O (recombinant humanized anti-VEGF mAb injection) indicated for ophthalmic diseases such as wet age-related macular degeneration (wAMD) and to grant an exclusive license to Essex to develop, manufacture and commercialize HLX04-O in the field of human ophthalmic therapies globally. Henlius and Essex will speed up the global multi-centre clinical trials of HLX04-O and apply marketing authorization in different countries and regions around the globe based on the research results. So far, the filing of clinical trial for HLX04-O has been approved by the Therapeutic Goods Administration, Australia and FDA, the United Stated. The multi-centre Phase 3 clinical study of the project is intended to be initiated in the near future. Looking forward, Henlius will continue to expand its global footprint, explore further license-in/out cooperation and ensure a global market coverage.

In the future, Henlius will continue to put commercialization on top priority, make the most out of the launched products and capitalize on first-entrant advantages in the field of biosimilar. Underpinned by the patient-centric strategy, Henlius looks forward to addressing the unmet needs by accelerating innovation and exploring pipeline opportunities through strategic collaboration and in-house innovation, highlighting its commitments to bringing more affordable and high-quality innovative products to more patients.

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, 3 products have been launched in China, 1 in the European Union (EU), the New Drug Applications (NDA) of 2 products accepted for review in China. 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 commercialisation. It has established global R&D centers and a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice (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 HLX10 (anti-PD-1 mAb) as backbone. Apart from the launched products 汉利康® (rituximab), the first China-developed biosimilar, 汉曲优® (trastuzumab, Zercepac® in the EU), the first China-developed mAb biosimilar approved both in China and in the EU and 汉达远® (adalimumab), the Company’s first product indicated for autoimmune diseases, the NDA of HLX04 (bevacizumab) and HLX01 (rituximab) for the treatment of rheumatoid arthritis are under review. What’s more, Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide, expanding its presence in major market as well as emerging market.

 

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SOURCE Henlius

TAIPEIMarch 27, 2021 /PRNewswire/ — Foresee Pharmaceuticals Co., Ltd. (6576.TWO) (“Foresee”), today announced the initiation of patient dosing in the Phase 2/3 clinical trial of FP-025, its highly selective oral MMP-12 inhibitor, in adult patients with severe to critical COVID-19 with associated Acute Respiratory Distress Syndrome (ARDS).

Dr. Ben Chien, founder and Chairman of Foresee, said, “We are pleased to begin this Phase 2/3 study of FP-025. FP-025 showed significant therapeutic efficacy in preclinical inflammation and fibrosis models of the lung, suggesting that FP-025 may potentially avert the lung injury and fibrosis caused by COVID–19 infections. We look forward to evaluating the potential of FP-025 in the fight against the pandemic.”

The Phase 2/3 trial is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of FP-025. The Phase 2 part will be conducted in the United States. Approximately 99 patients (18-65 years) with a diagnosis of severe to critical COVID 19 with associated ARDS will be randomized in a 1:1:1 ratio to receive FP-025 100 mg, FP-025 300 mg, or placebo twice daily for 28 days. The primary outcome measures of the trial include the proportion of patients alive and not requiring non-invasive or invasive ventilation at Day 28. An interim analysis is planned at the end of Phase 2 trial, of which the efficacy results are expected in the fourth quarter of 2021.

Based on the primary analysis results from Phase 2, an optimal dose will be selected to carry into Phase 3 of the study. Approximately 300 patients will be randomized in a 1:1 ratio to receive FP–025 or placebo for 28 days. For more information about the clinical trial, see www.clinicaltrials.gov, identifier NCT04750278.

About FP-025

FP 025 is a selective small molecule inhibitor of MMP-12. Key functions of MMP-12 include the modulation of numerous components of the extracellular matrix, namely elastin and collagen. MMP-12 also modulates effector proteins and cells, such as the influx of monocytes and macrophages involved in inflammation and fibrosis. MMP-12 is mainly produced and secreted by activated macrophages, as well as by pulmonary epithelial cells and chondrocytes. As such, MMP-12 is implicated in many inflammatory and fibrotic diseases of the lung, and a potential mediator of both inflammatory responses and structural remodeling that can occur in patients with COVID-19 associated respiratory disease.

FP–025 was shown to have effects in preclinical inflammation and fibrosis models, and is safe and efficacious in preclinical and clinical studies. FP-025 is currently being given at 400 mg BID for 12 days in a clinical study of patients with asthma; the study is ongoing and remains blinded. 

About
Foresee Pharmaceuticals Co. Ltd.

Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange. Foresee’s R&D efforts are focused in two key areas, namely its unique stabilized injectable formulation (SIF) depot delivery technology with derived drug products targeting specialty markets, and secondly its transformative preclinical and clinical first-in-class NCE programs targeting disease areas with high unmet needs.

Foresee’s product portfolio includes late stage and early stage programs. FP-001 – stable, ready-to-use versions of leuprolide mesylate for injection, for which regulatory approval reviews are currently underway in US and EU for the 6-month product and regulatory submissions for 3-month product are in preparation. FP-025 – a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, currently in Phase 2/3 studies, including a Phase 2/3 study for COVID-19 virus-induced acute respiratory distress syndrome (ARDS). FP-045 – a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 1b/2 study is currently planned for Fanconi Anemia. FP-004 – a novel, subcutaneously injectable product in development for the treatment of opioid use disorder and pain. www.foreseepharma.com

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SOURCE Foresee Pharmaceuticals Co., Ltd.

NEW YORK, March 27, 2021 /PRNewswire/ —

WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Ontrak, Inc. (NASDAQ: OTRK) between November 5, 2020 and February 26, 2021, inclusive (the “Class Period”), of the importantMay 3, 2021 lead plaintiff deadline.

SO WHAT: If you purchased Ontrak securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

WHAT TO DO NEXT: To join the Ontrak class action, go to http://www.rosenlegal.com/cases-register-2052.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] or [email protected] for information on the class action. A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than May 3, 2021. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.

WHY ROSEN LAW: We encourage investors to select qualified counsel with a track record of success in leadership roles. Often, firms issuing notices do not have comparable experience or resources. The Rosen Law Firm represents investors throughout the globe, concentrating its practice in securities class actions and shareholder derivative litigation. Rosen Law Firm has achieved the largest ever securities class action settlement against a Chinese Company. Rosen Law Firm was Ranked No. 1 by ISS Securities Class Action Services for number of securities class action settlements in 2017. The firm has been ranked in the top 4 each year since 2013 and has recovered hundreds of millions of dollars for investors. In 2019 alone the firm secured over $438 million for investors. In 2020 founding partner Laurence Rosen was named by law360 as a Titan of Plaintiffs’ Bar. Many of the firm’s attorneys have been recognized by Lawdragon and Super Lawyers.

DETAILS OF THE CASE: According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (1) Ontrak’s largest customer evaluated the Company on a provider basis, valuing Ontrak’s performance based on achieving the lowest cost per medical visit rather than clinical outcomes or medical cost savings; (2) as a result, Ontrak’s largest customer did not find the Company’s program to be effective and was reasonably likely to terminate its contract with Ontrak; (3) because this customer accounted for a significant portion of the Company’s revenue, the loss of the customer would have an outsized impact on Ontrak’s financial results; and (4) as a result of the foregoing, defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis. When the true details entered the market, the lawsuit claims that investors suffered damages.

To join the Ontrak class action, go to http://www.rosenlegal.com/cases-register-2052.html or call Phillip Kim, Esq. toll-free at 866-767-3653 or email [email protected] or [email protected] for information on the class action.

No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.

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Contact Information:

Laurence Rosen, Esq.

Phillip Kim, Esq.

The Rosen Law Firm, P.A.
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New York, NY 10016
Tel: (212) 686-1060
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SOURCE Rosen Law Firm, P.A.