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. 6887
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. 
