New Stock News | Hemei Pharmaceutical Passes HKEX Hearing, Cumulative Loss of 253 Million Over Two Years, Core Product Just Beginning Commercialization

According to the disclosure by the Hong Kong Stock Exchange on October 20, Ganzhou Hemei Pharmaceutical Co., Ltd. (referred to as: Hemei Pharmaceutical) has passed the listing hearing of the Main Board of the Hong Kong Stock Exchange, with Guotou Securities International as the sole sponsor. The prospectus shows that Hemei Pharmaceutical is a biopharmaceutical company dedicated to the discovery and development of independently discovered and independently developed small molecule drugs targeting autoimmune diseases and tumors. Currently, the company has a core product Mufemilast and five small molecule drug candidates. In September 2025, Mufemilast received NDA approval in China for the treatment of moderate-to-severe plaque psoriasis. Mufemilast is an independently discovered and independently developed small molecule PDE4/PDE4B inhibitor, and is also under review in pivotal Phase III trials for Behet's disease ("BD") and ulcerative colitis ("UC"). Phase II trials for atopic dermatitis ("AD"), psoriatic arthritis ("PsA"), Crohn's disease ("CD"), and chronic obstructive pulmonary disease ("COPD") are ongoing or planned in China. The product has been granted orphan drug designation by the FDA for BD. In addition, the company's clinical-stage drug candidates also include: Hemay022, Hemay007, Hemay808, Hemay181, and Hemay5087. In terms of R&D strategy, the company centers on a rigorous portfolio management approach, prioritizing the core product Mufemilast and key oncology assets Hemay022 and Hemay181. Hemay022 is a Class 1 small molecule inhibitor targeting both EGFR and HER2, intended for use as second-line and later therapy for advanced ER+/HER2+ breast cancer, and the company holds global rights to the drug. Currently, Hemay022 is undergoing Phase III clinical trials in China in combination with aromatase inhibitors (exemestane or letrozole) for the treatment of advanced ER+/HER2+ breast cancer. The company plans to submit an NDA application in China in December 2028. According to market data, the market size of HER2-positive breast cancer drugs in China is estimated to grow from RMB 11.4 billion in 2021 to RMB 16.5 billion in 2025, with a compound annual growth rate of 9.7%. In the future, the market size of HER2-positive breast cancer drugs in China will further grow to RMB 23.3 billion in 2028 and RMB 37.7 billion in 2032, with a compound annual growth rate of 12.2% from 2025 to 2028 and 12.8% from 2028 to 2032. Another R&D product, Hemay181, is a -GU-targeted glycosyl drug conjugate, or SDC drug, and is the first clinical-stage SDC drug in China that is activated by -GU in the tumor microenvironment, with anti-tumor potential. After administration, Hemay181 shows metabolic stability during systemic circulation. Upon reaching the tumor site, -GU cleaves Hemay181, releasing the cytotoxic drug SN38 (a topoisomerase I inhibitor that interferes with DNA replication and transcription in tumor cells), which is subsequently internalized by cancer cells and exerts toxic effects. The Phase I clinical trial of Hemay181 is being conducted in China to evaluate its safety, tolerability, pharmacokinetic characteristics, and preliminary anti-tumor efficacy. Currently, the company is conducting a Phase Ib clinical trial to evaluate the anti-tumor efficacy and safety of Hemay181 in patients with advanced solid tumors. In terms of financials, for the year 2024, the year 2025, and the four months ended April 30, 2026, the company's other income was approximately RMB 5.298 million, RMB 579.9, and RMB 591,000, respectively; during the same periods, the loss for the year/period was approximately RMB 123 million, RMB 130 million, and RMB 32.36 million, respectively.