Hybio Pharmaceutical

Shenzhen Hanyu Pharmaceutical Co., Ltd. announced on September 10, 2026 that it has received the Acceptance Notice for the clinical trial application of HY3003 Injection issued by the National Medical Products Administration. HY3003 is a Class 1 chemical drug and a novel GLP-1R/GIPR/GCGR triple receptor agonist. The indication filed this time is long-term weight management in adults, namely obesity with BMI of 28 kg/m² or above, or overweight with BMI of 24 kg/m² or above accompanied by at least one weight-related comorbidity. The drug is co-developed by Hanyu Pharmaceutical and Shenzhen Carbonsmart Peptide Drug Technology Co., Ltd., with the novel peptide molecule screened through artificial intelligence combined with peptide chip technology. The two parties signed a joint development agreement in May 2025. Hanyu Pharmaceutical is responsible for preclinical research, IND filing, and subsequent clinical trial development, with intended indications including weight loss, type 2 diabetes, and metabolic-associated steatohepatitis. The company stated that the acceptance of the HY3003 clinical trial application marks a key leap in its GLP-1 product portfolio from generic drug layout to original innovative drug research and development. Subsequent clinical trials and marketing authorization application and registration are still required, and whether it can be successfully launched remains uncertain.

Shenzhen Hybio Pharmaceutical announced that its liraglutide injection has been approved for marketing by the Singapore Health Sciences Authority, with registration number SIN17618P and an issue date of August 20, 2026. The product is an injection in a prefilled pen, with a strength of 6 mg per ml, indicated for glycemic control in adults with type 2 diabetes. In overseas markets, the product received first generic approval from the U.S. FDA in December 2024 and has been marketed and sold, making it the first generic version of this drug approved by the FDA. In the domestic market, the product was approved for marketing in June 2026, becoming the first liraglutide formulation in China approved as a modified new drug under Category 2.2 of chemical drugs and produced through a fully chemical synthesis route, with the same formulation, process, and manufacturing site as the product approved in the United States. The company stated that this approval represents an important step in its internationalization strategy in the Southeast Asian market, helping to expand its business footprint and enrich its overseas pipeline of finished drug products. However, the specific timing and scale of sales are subject to local market conditions, competitive dynamics, exchange rate fluctuations, and other factors, and therefore remain uncertain.

Hybio Pharmaceutical released its 2026 interim report, with net profit attributable to the parent company of 237 million yuan. The company's total operating revenue was 688 million yuan, and net cash inflow from operating activities was 305 million yuan. The latest gross margin was 62.91 percent, down 1.98 percentage points from the previous quarter, and the latest return on equity was 27.84 percent. Diluted earnings per share were 0.27 yuan, and the asset-liability ratio was 75.65 percent.

On the evening of August 12, several listed companies on the Shanghai and Shenzhen stock exchanges released important positive announcements. Suzhou ShuoBeiDe plans to raise no more than 1.096 billion yuan through a private placement, for projects including server cooling modules, lightweight radio-frequency components for smart glasses, and low-earth-orbit satellite communication antennas and modules. Hybio Pharmaceutical signed a cooperation agreement with Shenyang Sunshine Pharmaceutical for a semaglutide injection blood glucose control indication, under which the two parties will carry out development, registration, production, and commercialization cooperation in China. CFMOTO's U.S. subsidiary has cumulatively received refunds of U.S. tariffs and interest totaling 38.6079 million U.S. dollars, which is expected to affect the company's 2026 net profit by approximately 183 million yuan. Weihua New Materials plans to repurchase shares for 80 million to 120 million yuan, to be used for employee stock ownership plans or equity incentives. Haining Leather City New Energy plans to purchase equity in a total of 38 target photovoltaic companies for 226 million yuan.

On the evening of August 12, multiple listed companies on the Shanghai and Shenzhen stock exchanges issued major announcements. Antong Holdings announced that its single largest shareholder, Sinotrans Container Lines, plans to reorganize the board of directors. If the relevant proposals are approved by the shareholders' meeting, the company's controlling shareholder will change from Fujian Zhaohang Logistics Management Partnership to Sinotrans Container Lines, and the actual controller will change from having no actual controller to China Merchants Group. Speed Wireless Technology plans to raise no more than 1.096 billion yuan through a private placement, for projects including server cooling modules, lightweight radio frequency components for smart glasses, and low-orbit satellite communication antennas and modules. Hybio Pharmaceutical signed a cooperation agreement with Shenzhen Salubris Pharmaceuticals for the blood glucose control indication of semaglutide injection, under which the two parties will cooperate in development, registration, production, and commercialization in China. CATL plans to participate as a limited partner in the Hainan Times Green Industry Investment Fund, with a committed capital contribution of 2.475 billion yuan, holding a 49.5% stake in the fund. Sinosun Technology announced that Jinghexing plans to acquire a 14.18% stake in the company held by Xinjiang Chaojun for 539 million yuan. After the transaction is completed, Jinghexing will become the controlling shareholder, and Qu Jialin will become the actual controller. The company's shares will resume trading on August 13. In terms of financial results, Yihai Kerry Arawana reported a net profit of 2.294 billion yuan in the first half of the year, up 30.69% year-on-year; Shanghai Pudong Development Bank reported a net profit of 30.951 billion yuan in the first half, up 4.08% year-on-year; Baofeng Energy reported a net profit of 9.728 billion yuan in the first half, up 70.14% year-on-year; Quectel Wireless Solutions reported a net profit of 602 million yuan in the first half, up 27.84% year-on-year.

Hybio Pharmaceutical announced that its marketing application for tirzepatide injection has been accepted by the National Medical Products Administration, making it the first company in China to file for marketing approval of this drug. The drug is a Category 4 chemical medicine, with indications including type 2 diabetes, long-term weight management, and obstructive sleep apnea. Tirzepatide is a GLP-1R/GIPR dual-target agonist developed by Eli Lilly. In 2025, its global sales totaled approximately 36.507 billion US dollars, with the diabetes version Mounjaro generating about 22.965 billion dollars and the weight-loss version Zepbound about 13.542 billion dollars. Currently, only Eli Lilly's imported and localized products are available in China. In the first quarter of 2026, Hybio Pharmaceutical achieved revenue of 299 million yuan and a net profit attributable to the parent company of 128 million yuan.

Shenzhen Hybio Pharmaceutical Co., Ltd. announced that the domestic manufacturing marketing authorization application for semaglutide injection for weight loss, filed by its partner Zhejiang 3SBio-Mandy Pharmaceutical Co., Ltd., has been formally accepted by the Center for Drug Evaluation of the National Medical Products Administration. A total of five application numbers were accepted, covering the mainstream clinical specifications of the product. In May 2024, Hybio Pharmaceutical signed a cooperation agreement with 3SBio-Mandy, under which Hybio Pharmaceutical acts as the entrusted research, development, and manufacturing party as the marketing authorization holder, while 3SBio-Mandy serves as the marketing authorization holder and commercialization lead. In August 2025, the two parties signed a supplementary agreement clarifying matters such as production supply after product approval. The company stated that this acceptance marks an important milestone in the cooperation. If the product is successfully approved and launched, it will further enhance the company's layout in the GLP-1 peptide drug field. At the same time, it cautioned that the registration application is only at the initial review stage, and there are significant uncertainties regarding final approval and sales performance.