New Stock News | Tongyuan Health Medicine refiles with the Hong Kong Stock Exchange. As of the end of March, the company is still in a continuous state of loss.

According to the disclosure by the Hong Kong Stock Exchange on July 29th, Zhejiang Tongyuan Kang Medicine Co., Ltd.-B (referred to as Tongyuan Kang Medicine) has submitted an application for listing on the main board of the Hong Kong Stock Exchange, with CITIC SEC as its exclusive sponsor. It is reported that the company had previously submitted a listing application to the Hong Kong Stock Exchange on January 26th. The prospectus reveals that Tongyuan Kang Medicine is a clinical-stage biopharmaceutical company dedicated to discovering, acquiring, developing, and commercializing differentiated targeted therapies to meet the urgent medical needs in cancer treatment. Since its establishment in 2017, the company has built a pipeline consisting of 11 candidate drugs, including the core product TY-9591, six clinical-stage products, and four pre-clinical stage products. Currently, the company is conducting a key Phase II clinical trial in China for TY-9591 monotherapy, using it as a first-line treatment for brain metastases in non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations, and conducting a registrational Phase III clinical trial in China for TY-9591 monotherapy, using it as a first-line treatment for locally advanced (stage IIIb or IV) or metastatic NSCLC with EGFRL858R mutations. It is reported that NSCLC accounts for 85% of all epithelial lung cancers other than small cell lung cancer (SCLC). According to Frost & Sullivan data, EGFR mutations account for 50.2% of all NSCLC patients in China by 2023. According to Frost & Sullivan data, TY-9591 is the only global EGFR-TKI undergoing head-to-head registrational clinical trials to directly compare its efficacy with that of osimertinib. To fully explore the potential of TY-9591, Tongyuan Kang Medicine has also applied for Phase II and III clinical trials for TY-9591 in combination with pemigatinib and platinum-based chemotherapies as first-line treatments for late-stage or metastatic NSCLC with EGFR mutations for a predicted start in the second half of 2024. In terms of finances, Tongyuan Kang Medicine had research and development costs of approximately 230 million yuan, 249 million yuan, and 64.699 million yuan in 2022, 2023, and the three months ended March 31, 2024, respectively. The company achieved revenue of 44.242 million yuan in 2022, and recorded losses of 312 million yuan, 383 million yuan, and 108 million yuan in 2022, 2023, and the three months ended March 31, 2024, respectively. Tongyuan Kang Medicine stated that the increase in losses from 312 million yuan in 2022 to 383 million yuan in 2023 was mainly due to the recognition of income related to TY-2136b from LIVZON PHARMA in 2022, while no milestone triggering LIVZON PHARMA's payment obligation was reached by December 31, 2023. It should be noted that Tongyuan Kang Medicine may be affected by interruptions or suspensions in its manufacturing activities if it fails to obtain and maintain regulatory approvals for its production facilities. As of the last practicable date, Tongyuan Kang Medicine had no operational internal production facilities. For future commercialization, the company is constructing cGMP-compliant internal production facilities in Huzhou, Zhejiang Province, expected to commence operations in 2025. Failure to obtain and maintain regulatory approvals for production facilities may limit the company's development, commercialization activities, and growth opportunities. Cost overruns related to maintaining the company's production facilities may require additional funding from other sources. Furthermore, Tongyuan Kang Medicine noted in its prospectus that FDA has granted orphan drug designation to TY-2136b for the treatment of NSCLC, but the company may not be able to maintain or obtain benefits related to orphan drug status, including market exclusivity. Regulatory agencies in certain jurisdictions (including the United States) may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, if a drug is intended for the treatment of rare diseases or conditions, FDA may designate it as an orphan drug, with such diseases or conditions typically defined in the United States as affecting fewer than 200,000 patients. The company's candidate product TY-2136b has been granted orphan drug designation by FDA for the treatment of ROS1-positive, NTRK fusion-positive, ALK-positive, or LTK-positive NSCLC. Generally, if a product is granted orphan drug designation and subsequently receives initial market approval for its designated indication, the product is entitled to a period of market exclusivity, during which FDA will not approve applications for similar drugs in the same indication. In the United States, the exclusivity period is 7 years. Tongyuan Kang Medicine cannot guarantee that other drugs will not receive market approval before TY-2136b. If FDA determines that the designation request has significant deficiencies, or if the manufacturer cannot ensure an adequate supply of the drug to meet the needs of patients with rare diseases or conditions, the company may lose its orphan drug exclusivity.