HSK21542 注射液“腹部手术术后镇痛”适应症已于2023 年10 月申报NDA，目前处于上市审评阶段。另一适应症——“慢性肾脏疾病相关性瘙痒”的已完成PNDA 沟通交流会议，并于2024 年6 月纳入优先审评，新增“术后恶心呕吐”适应症已于7 月申报IND，目前正在审评中。HSK21542 的口服制剂（HSK21542 片）正在开展“慢性瘙痒”适应症的临床Ⅱ期研究。Incident: The company released its 2024 semi-annual report. In the first half of the year, it achieved operating income of 1.69 billion yuan (+23.1%), net profit to mother of 0.16 billion yuan (+119.4%), after deducting non-return net profit of 0.08 billion yuan (+2.5%).
Sales of cyclopofol are growing rapidly and are expected to file an NDA in the US. All indications for injections are covered by national health insurance, and the market share in the field of intravenous anesthesia has reached the top 1 of similar products. Two US phase III clinical trials with “total anesthesia-induced” indications have all been completed and will be declared for NDA in the US.
The two indications of cligabarin benzenesulfonate capsules were approved for marketing in May and June 2024, respectively. It is the first treatment for “adult diabetic peripheral neuropathic pain and post-herpes zoster neuralgia” to be marketed domestically. “Assisted analgesia” submitted an EOP2 communication application in June 2024, awaiting feedback from the CDE; the two new INDs for “pathological pain of the central nervous system” and “fibromyalgia” have been approved. Among them, “pathological pain of the central nervous system” has already started Phase III clinical investigation. Within 40 days of launch, Simining achieved sales of about 4 million yuan, reflecting huge unmet clinical demand and Hysco's ability to quickly commercialize.
The indication for “pain relief after abdominal surgery” for HSK21542 injections was declared for NDA in October 2023 and is currently under marketing review. Another indication — “chronic kidney disease-related pruritus,” completed the PNDA communication meeting and was included in the priority review in June 2024. The additional “postoperative nausea and vomiting” indication was declared IND in July and is currently under review. Oral formulations of HSK21542 (HSK21542 tablets) are undergoing phase II clinical studies for “chronic pruritus” indications.
The world's first ultra-long-lasting two-week oral hypoglycemic drug has been approved for marketing, and the innovation pipeline is progressing rapidly. Coglitin tablets obtained a drug registration certificate for “improving blood sugar control in adults with type 2 diabetes” in June 2024. It is the world's first ultra-long-lasting two-week oral hypoglycemic drug. The HSK31858 tablets “non-cystic fibrosis bronchiectasis” have completed phase II clinical trials in China, and INDs for two new indications, “bronchial asthma” and “chronic obstructive pulmonary disease,” were approved in early April. HSK39004 inhalation suspension for COPD and IND for HSK44459 tablets to treat interstitial lung disease have both been approved. HSK31679 tablets “Adult Essential Hypercholesterolemia” have completed phase II clinical trials, and phase II clinical trials of “NASH” are progressing smoothly.
Profit forecast and investment advice: The company's innovative drugs have entered the harvest period and are expected to contribute to greater performance flexibility. At the same time, the company has rich reserves of innovative varieties and sufficient momentum for long-term performance growth. The company's net profit for 2024-2026 is estimated to be 0.4 billion yuan, 0.57 billion yuan, and 760 million yuan, corresponding to PE of 81 times, 57 times, and 42 times, respectively, maintaining a “buy” rating.
Risk warning: market competition risk, drug price decline risk, new drug development risk.