Major Pharma Announcements on February 17, 2025: NDA Submissions and Corporate Updates

　　【Pharmaceutical Network Industry DynamicsOn February 17, 2025, announcements from several major pharmaceutical companies created ripples across the industry, drawing significant attention.
 

First, let's look at the announcement from Onlly. From January 15 to February 13, 2025, Shanghai Shijie Decoration Design Engineering Co., Ltd. initiated a tender offer to acquire Onlly. This tender offer plans to acquire 38.75 million shares of Onlly, representing 5% of the company’s total share capital, at an offer price of 4.5 yuan per share. However, the acquisition results showed that the total number of shareholder accounts that preliminarily accepted the offer was only 23, with a total of 530,000 shares preliminarily tendered, accounting for 0.0687% of the company’s current total shares. In the end, Shanghai Shijie will hold 53.25 million shares of the company, representing 6.8715% of the total share capital. Notably, Shanghai Shijie and its acting-in-concert parties collectively hold 233 million shares of the company, accounting for 30.0620% of the total share capital. Despite this, after the completion of this tender offer, the equity distribution of Onlly still meets the listing requirements, and its listed status remains unaffected. The company's stock also officially resumed trading on February 17. For Onlly, although Shanghai Shijie’s acquisition did not reach the expected scale, the slight change in the equity structure may bring new opportunities and challenges for the company’s future development. Investors will also take this opportunity to reassess Onlly's position and development potential in the market.
 

IASO Bio's Announcement Similarly Draws Attention. IASO Bio announced that its CAR-T cell product, Idecabtagene Vicleucel Injection (FUCASO), has been formally accepted by the Hong Kong Department of Health for a New Drug Application (NDA). It is intended for treating adult patients with relapsed/refractory multiple myeloma (R/RMM) who have progressed after at least three prior lines of therapy. This news is significant because Idecabtagene Vicleucel Injection has already been supplied cross-border to patients in the Hong Kong region. Once approved in Hong Kong, patients there will be able to directly access the product manufactured at IASO Bio’s Nanjing production base. As early as June 2023, Idecabtagene Vicleucel Injection received approval from China’s National Medical Products Administration (NMPA) for marketing, for treating adult patients with relapsed or refractory multiple myeloma who have progressed after at least three prior lines of therapy. Since its establishment, IASO Bio has focused on developing hematological tumor cell-based drugs as the cornerstone of innovation and has continuously expanded into autoimmune diseases and antibody-based drugs. The submission of this marketing application to the Hong Kong Department of Health represents an important step in its international strategy, offering innovative treatment options to Hong Kong patients while also marking a solid step forward for China’s cell therapy technology in global competition.
 

Hengrui Pharma Reports Good News: The Company Recently Received the "Acceptance Notice" Issued by the National Medical Products Administration (NMPA). The Marketing Authorization Application for the Drug Ermacytinib Ointment Submitted by the Company Has Been Accepted by the NMPA. Ermacytinib Ointment (SHR0302 Alkaline Ointment) Is Proposed for the Topical Treatment of Mild to Moderate Atopic Dermatitis in Adults. Atopic dermatitis is a chronic inflammatory skin disease with complex lesions and diverse clinical manifestations and symptoms. Typical presentations include skin pigmentation, dryness, cracking or scaly plaques, and pruritus, which seriously affect patients' quality of life. There is a lack of long-term effective treatment methods to control the disease clinically. Currently, new products targeting immune response regulation are being actively researched globally, and there is an urgent need to develop safer and more effective therapeutic drugs. Ermacytinib Ointment is a topically applied, highly selective JAK1 inhibitor that can better inhibit JAK1 signaling through high local exposure, exerting anti-inflammatory and immunosuppressive biological effects. For the indication of atopic dermatitis, there are currently two similar topical medications approved and marketed worldwide. Relevant data show that the combined global sales of similar products in 2023 were approximately $392 million.
 

The industry believes that the changes in Onlly's equity structure will test the company’s strategic adjustment and market response capabilities; IASO Bio’s breakthroughs in its internationalization process have set an example for China’s cell therapy industry and brought more treatment options to patients worldwide; Hengrui Pharma's submission of the marketing authorization application for Imasitinib Ointment has been accepted by the National Medical Products Administration, which may provide new treatment options for patients with atopic dermatitis in the future.
 

Disclaimer: Under no circumstances shall the information or opinions expressed in this article constitute investment advice to any person.