Announcement • May 29
Sunshine Lake Pharma Co., Ltd., Annual General Meeting, Jun 18, 2026 Sunshine Lake Pharma Co., Ltd., Annual General Meeting, Jun 18, 2026, at 10:00 China Standard Time. Location: conference room, 3/f, sales building, dongyangguang scientific park, no. 368 zhen an zhong road, changan county, dongguan, guangdong province, China Announcement • May 06
Lanexa Biologics LLC Announces FDA Approval of LANGLARA an Interchangeable Biosimilar of Lantus Lannett Company, Inc., Lanexa Biologics, a wholly owned subsidiary of Lannett, and Sunshine Lake Pharma announced that the U.S. Food and Drug Administration (FDA) has approved LANGLARA (insulin glargine-aldy), as a biosimilar to Lantus (insulin glargine), for the treatment of adults and pediatric patients with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. The FDA has determined that LANGLARA is interchangeable with the reference drug, enabling pharmacists to substitute LANGLARA for Lantus without prescriber intervention in states that permit such substitution. The approval for LANGLARA was based on a comprehensive analytical, preclinical and clinical program which confirmed the PK/PD, efficacy, safety profile and immunogenicity of LANGLARA as compared to Lantus in patients with type 1 and type 2 diabetes. LANGLARA is manufactured by Sunshine Lake Pharma Co., Ltd., which is the pharmaceutical business arm of HEC Group and commercialized in the United States exclusively through Lanexa Biologics LLC, a newly formed wholly owned subsidiary of Lannett Company. FDA Biosimilar Interchangeability Designation: An interchangeable biosimilar is a biosimilar that may be substituted for the reference product without the intervention of the prescribing health care provider, depending on state pharmacy laws. Not all biosimilars are interchangeable biosimilars. A manufacturer must specifically seek FDA approval for an interchangeable product. The approval process for interchangeable biosimilars has additional requirements related to the potential for substitution. Patients receiving their medications through their pharmacies may be able to switch between a brand-name biological product and an interchangeable biosimilar. LANGLARA is manufactured by Sunshine Lake Pharma, a biopharmaceutical company with biologics manufacturing capabilities and a track record of regulatory compliance across international markets. The collaboration between Lannett and Sunshine Lake Pharma reflects a commitment to delivering high-quality, affordable biologic medicines to patients who need them. Sunshine Lake Pharma’s manufacturing facility has been designed and operated to meet the standards of both the FDA and international regulatory authorities, providing a robust and scalable supply chain for LANGLARA and future pipeline products. Lannett and Sunshine Lake Pharma also continue to collaborate on a short acting insulin aspart which is in development. Lanexa Biologics LLC is a wholly owned subsidiary of Lannett Company, Inc., established to serve as the commercial platform for Lannett’s biosimilar portfolio in the United States. Lanexa combines the distribution infrastructure, payer relationships, and regulatory expertise of its parent company with a dedicated focus on the unique commercial demands of the biologics market. The formation of Lanexa reflects Lannett’s commitment to biosimilars as a core growth driver and its belief that purpose-built commercial capabilities are essential to competing effectively in this space. LANGLARA is Lanexa’s inaugural insulin product. A short acting insulin aspart is also under development. Live News • May 05
Sunshine Lake Pharma Linked to FDA Approved Interchangeable Insulin Biosimilar for US Market Lannett Company, Lanexa Biologics and Sunshine Lake Pharma received FDA approval for LANGLARA, a biosimilar to Lantus for type 1 and type 2 diabetes.
LANGLARA has been designated by the FDA as interchangeable with Lantus, allowing pharmacist substitution where local regulations permit.
Sunshine Lake Pharma will manufacture LANGLARA, while commercialization in the U.S. will be handled by Lanexa Biologics, a new Lannett subsidiary.
For you as an investor, the key point is that Sunshine Lake Pharma is now directly linked to an FDA-approved insulin glargine biosimilar that can be substituted at the pharmacy level for Lantus in the U.S. Interchangeability status is significant because it can lower barriers to adoption in markets where substitution rules apply, although actual uptake will still depend on pricing, payer decisions and competitive responses.
Sunshine Lake’s role is on the manufacturing side, with Lannett and Lanexa Biologics responsible for U.S. commercialization. When assessing this development, you may want to focus on how the manufacturing relationship is structured, what volumes could look like over time, and how this product fits alongside Sunshine Lake’s existing portfolio and geographic mix. Competitive dynamics in insulin biosimilars and any future regulatory milestones or label expansions may also be relevant for your ongoing tracking. New Risk • Apr 19
New major risk - Financial position The company's interest payments are not well covered by earnings. Net interest cover: 2.9x This is considered a major risk. If the company is unable to fund interest repayments on its debt through profits, it may be forced into reducing its debt burden through selling assets, undertaking a potentially costly capital raising or even into bankruptcy in the worst case scenario. Currently, the following risks have been identified for the company: Major Risk Interest payments are not well covered by earnings (2.9x net interest cover). Minor Risk Profit margins are more than 30% lower than last year (5.7% net profit margin). Announcement • Mar 23
Sunshine Lake Pharma Co., Ltd. to Report Fiscal Year 2025 Results on Mar 31, 2026 Sunshine Lake Pharma Co., Ltd. announced that they will report fiscal year 2025 results on Mar 31, 2026 Announcement • Jan 16
Sunshine Lake Pharma Co., Ltd. Obtains Marketing Approval from China National Medical Products Administration The board of directors of Sunshine Lake Pharma Co., Ltd. announced that a sodium glucose transporter 2 inhibitor (SGLT-2 inhibitor) and Class 1 innovative drug Olorigliflozin Capsules (Product Name: Dong Ze'an (Dong Ze An); Strength: 20mg, 50mg) (the 'Product'), independently researched and developed by the Group, has recently obtained marketing approval from China National Medical Products Administration (the 'NMPA' for use as monotherapy or in combination with metformin to improve glycemic control in adults with type 2 diabetes. The registration approval of the Product is based on two Phase III clinical studies, which are multi-centered, randomized, double-blind and placebo-controlled. After 24 weeks of treatment, Olorigliflozin capsules demonstrated a significant reduction in glycated hemoglobin (HbA1c) level compared to baseline statistically. The fasting blood glucose of the patients, in particularly, their 2-hour postprandial glucose, showed significant improvement. Meanwhile, metabolic benefits, including body weight loss and systolic blood pressure reduction were also observed. The Product demonstrated remarkable efficacy in improving energy metabolism, in line with the contemporary trends in integrated diabetes management focusing on blood glucose-body weight-blood pressure''. During clinical trials, the Product exhibited overall good tolerability, with no significant difference in the incidence of adverse events compared to the placebo groups. Announcement • Jan 06
Sunshine Lake Pharma Co., Ltd. Announces on Phase I Clinical Trial of HECN30227 (Sirna Therapeutic T Targeting Hepatis B Virus) and Progress in the Development of Small Nucleic Acid Therapeutics Sun Lake Pharma Co., Ltd. announced that it is a Class 1 new drug independently developed by the Group, for which the company hold global intellectual property rights. It simultaneously eliminates hepatitis B surface antigen (HBsAg) originating from both cccDNA and intDNA. Preclinical data indicate that HECN30227 exhibits pan-genotypic activity, which is able to effectively reduce HBsAg levels while maintaining outstanding efficacy against strains that resist nucleoside analogue, with its in vitro and in vivo efficacy surpassing that of clinical competitors. The employment of HEC-GalNova (N-acetylgalactosamine), a liver-targeting delivery system uniquely designed by the Group, enables HECN30227 to achieve precise and efficient hepatic delivery while substantially reducing off-target risks. Currently, HECN30227 has completed enrolment of the first domestic subject. The significant findings from the preclinical study of HECN30227 in combination with proprietary immunomodulator HEC191834 have been selected for the 'Poster of Distinction' at the 2025 Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). This distinction is reserved for the top 10% of submissions, signifying the high recognition by a world-renowned academic institution of the clinical development potential of the HECN30227 combination therapy. Since 2022, the Group has ventured into the small nucleic acid field, establishing an end-to-end research and development (''R&D'') platform encompassing'target discovery - sequence design and synthesis - chemical modification - delivery technology - biological evaluation', with its R&D capabilities ascending to the forefront of the domestic industry. Leveraging this comprehensive technology platform, the Company has filed over 50 patent applications and established more than 10 small nucleic acid pipelines spanning four major therapeutic areas: anti-infectives, cardiovascular-renal-metabolic disorders, respiratory diseases, and oncology. Moving forward, the Company plans to advance multiple small nucleic acid therapeutics into clinical development annually, thereby continuously consolidating its technological leadership in the small nucleic acid therapeutics field. The key preclinical products include: HBV ASO: In addition to HECN30227, the Company is simultaneously developing a ''siRNA + ASO + immunomodulator' combination therapy, which comprehensively suppresses HBV and HBsAg through multi-target synergistic effects. HEC ASO has demonstrated superior preclinical in vitro and in vivo efficacy compared to competitive products. Dual-target series: Through the 'one drug, two targets' design, this approach simultaneously silences two pathogenic genes or multiple regions of the same gene, providing an efficient solution for combined interventions in complex diseases. The dual-target pipeline for hyperlipidemia and hyperlipidemia-hypertension is currently showing potent and lasting activity in large animal models. In addition, the dual-target pipeline for indications such as MASH is steadily progressing, and will gradually advance into clinical stages in clinical stages. Fat-targeting, lung-targeting, and antibody-oligonucleotide conjugate (AOC): For the ALK7 target, which is highly expressed in adipose tissue, the Company's proprietary delivery vector has shown significantly superior ALK7 knockdown activity in mouse adipose tissue compared to positive controls, with multiple ALK7 in vitro sequence activities outperforming the positive control. Moreover, the dual-target pipeline of the treatment of pulmonary fibrosis (lung-targeting) and the AOC pipeline for cancer treatment are steadily advancing and will gradually progress into clinical stages in clinical stages in stages in clinical stages. For the ALK7 targets, which is highly expressed in fatose tissue, the Company's patented delivery vector has shown significantly superiorALK7 knockdown activity in mice adipose tissue compared to positive control. Moreover, the Dual-target pipeline for the treatment of pulmonary fibrosis ("lung-targeting") and the Aoc pipeline for cancer treatment are steadily progressing and will gradually progress into clinical stage in clinical stages in clinical stages in patients. New Risk • Dec 31
New major risk - Revenue and earnings growth Revenue has declined by 41% over the past year. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If revenues are declining, then it is difficult for the company to prevent its earnings from declining as well. A trend of falling revenue can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Revenue has declined by 41% over the past year. Minor Risks Latest financial reports are more than 6 months old (reported December 2024 fiscal period end). Profit margins are more than 30% lower than last year (13% net profit margin). New Risk • Nov 14
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2024. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Minor Risks Latest financial reports are more than 6 months old (reported December 2024 fiscal period end). Profit margins are more than 30% lower than last year (13% net profit margin). Board Change • Aug 11
Less than half of directors are independent There is 1 new director who has joined the board in the last 3 years. The new board member was not an independent director. The company's board is composed of: 1 new director. 4 experienced directors. 6 highly experienced directors. 3 independent directors (5 non-independent directors). Independent Non-Executive Director Xuechen Li was the last independent director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Insufficient board refreshment. 
