Apeloa Pharmaceutical Co Ltd

Apeloa Pharmaceutical Co., Ltd. announced that its wholly owned subsidiary Zhejiang Apeloa Jutai Pharmaceutical Co., Ltd. has received notification from the US FDA that its abbreviated new drug application for Brivaracetam Tablets has been approved. The ANDA number is 220136, with approved strengths of 25 mg, 50 mg, and 100 mg, primarily indicated for the treatment of partial-onset seizures. The manufacturer is Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. Brivaracetam Tablets are a novel antiepileptic drug and a derivative of the second-generation antiepileptic drug levetiracetam. According to relevant data, sales of Brivaracetam Tablets in the US market in 2025 were approximately 823 million US dollars. The company stated that this approval marks its qualification to sell the product in the US market, will further enhance the product's global market competitiveness, and actively expand into the US and other overseas markets. It also noted that production and sales of the product may be affected by uncertainties such as policy and market conditions.

Apeloa Pharmaceutical Co., Ltd. announced that its wholly owned subsidiary Zhejiang Apeloa Debang Pharmaceutical Co., Ltd. has received the Chemical Active Pharmaceutical Ingredient Marketing Application Approval Notice for cefditoren pivoxil issued by the National Medical Products Administration, with registration number Y20250000349 and packaging specifications of 5 kg per drum, 10 kg per drum, and 25 kg per drum. Cefditoren pivoxil is a third-generation cephalosporin antibiotic indicated for infections of the respiratory tract, urinary system, biliary tract, skin and soft tissue, as well as infections in obstetrics and gynecology, ophthalmology, and stomatology caused by susceptible bacteria. The company stated that this approval signifies that the API is qualified for domestic sales, which will broaden the company's product pipeline and advance the development of its API business, while also noting that pharmaceutical production and sales are subject to uncertainties arising from policies, regulations, and the market environment.

Zhejiang Apeloa Kangyu Pharmaceutical, a controlled subsidiary of Apeloa Pharmaceutical, has received a Drug Registration Certificate from the National Medical Products Administration for pentoxifylline extended-release tablets at 0.4 grams. The drug is registered as a Category 3 chemical drug and is deemed to have passed the generic drug consistency evaluation. It is indicated for peripheral vascular diseases. In 2025, the domestic market size was approximately 52.27 million tablets, with sales of around 262 million yuan. The company stated that the approval will further enrich its product line and enhance market competitiveness.

The A-share CRO sector surged on the morning of August 7, with the sector index climbing 7.37% to top all sector gainers. Among the 41 constituent stocks, 15 rose more than 10%, including Bide Pharmaceutical, Yaokang Bio, Baihua Pharmaceutical, Apeloa Pharmaceutical, and Asymchem hitting their daily limit up, while another 17 stocks such as BioMap, Joinn Laboratories, Tigermed, and WuXi AppTec gained over 5%. Earnings were the main driver, after BioMap released a profit forecast the previous evening, projecting attributable net profit of 236 million to 246 million yuan for the first half of 2026, a year-on-year increase of 3.92 to 4.13 times. So far, eight CRO companies have reported half-year results or profit forecasts, with six expecting double-digit or higher growth. Joinn Laboratories and Medicilon had previously forecast first-half profit to double. Sector leader WuXi AppTec reported in its half-year results this week that attributable net profit reached 11.08 billion yuan in the first half, up 29.43% year-on-year, surpassing 10 billion yuan for the first time in a first half. It also raised its full-year 2026 revenue guidance to between 58.5 billion and 60.5 billion yuan, with continuing operations revenue growth raised to 35% to 39%. The turnaround in CRO earnings stems from rising orders, as a sustained recovery in global pharmaceutical investment and financing drives renewed demand for innovative drug R&D. BioMap said its two major business lines achieved dual-engine growth, while WuXi AppTec's continuing operations backlog reached 66.43 billion yuan as of end-June, up 25.2% year-on-year. A research note from China Post Securities argued that overseas R&D outsourcing demand is steadily recovering, and a boost in domestic R&D outsourcing demand is expected to materialize in 2026.

Apeloa Pharmaceutical's controlling subsidiary, Kangyu Pharmaceutical, has recently received the Drug Registration Certificate for Levocarnitine Oral Solution from the National Medical Products Administration. The drug is an oral solution with specifications including 10 ml:1 g and 10 ml:2 g, primarily used for the treatment of primary systemic carnitine deficiency and secondary carnitine deficiency caused by congenital metabolic abnormalities. The domestic market size in 2025 is estimated at approximately 40.67 million units, with sales of around 298 million yuan. In the first quarter of 2026, Apeloa Pharmaceutical achieved revenue of 2.447 billion yuan and net profit attributable to the parent company of 249 million yuan.

Apeloa Pharmaceutical's holding subsidiary Anteyutai has signed a five-year Strategic Cooperation Framework Agreement with WuXi Biologics and Duoning Biotech. The three parties will jointly promote the development of Anteyutai's large-molecule drug pipeline, industrialization capacity building, and supply chain system improvement. Under the agreement, WuXi Biologics will provide Anteyutai with full-process R&D and manufacturing services for biologics, commercial production and supply assurance, commercial production workshop construction and GMP empowerment, and may explore capital cooperation such as equity investment. Duoning Biotech, as a strategic supplier, will provide core consumables including culture media, filter membranes, and chromatography resins, along with supporting hardware solutions, to help achieve process synergy, cost reduction, and supply chain stability.

Apeloa Pharmaceutical's wholly-owned subsidiary Jiayuan Pharmaceutical recently received a Certificate of Suitability to the European Pharmacopoeia for the gabapentin active pharmaceutical ingredient from the European Directorate for the Quality of Medicines. The certificate takes effect from July 10, 2026. Gabapentin is a synthetic amino acid primarily used to treat postherpetic neuralgia and epilepsy. In the first quarter of 2026, Apeloa Pharmaceutical achieved revenue of 2.447 billion yuan and net profit attributable to the parent company of 249 million yuan.

Apeloa Pharmaceutical announced it will invest 3.46 million yuan to participate in the establishment of Zhejiang Ante Yutai Biotechnology Company. The company signed an investment agreement with Hengdian Company, Zhenyu Taibo Yutai, and Yuan Yutai on July 15, 2026, to jointly set up the new firm with a registered capital of 10 million yuan. Apeloa Pharmaceutical subscribed for 3.46 million yuan, accounting for 34.58 percent. The company stated that this investment aligns with its strategic layout, aiming to enter the high-growth biopharmaceutical sector, enrich its product pipeline, and optimize its business structure. In the first quarter of 2026, Apeloa Pharmaceutical reported revenue of 2.447 billion yuan and net profit attributable to the parent company of 249 million yuan.