Core Viewpoint - The company’s PCV13 vaccine recently received GMP certification from the Turkish drug regulatory authority, indicating that the product meets the necessary conditions for entry into the Turkish market, which is expected to further open up the Turkish market and lay a solid foundation for expansion into surrounding markets in the Middle East and Africa [1][2][3] Event - On July 1, the company announced that its wholly-owned subsidiary, Minhai Biotech, received GMP certification for its 13-valent pneumococcal conjugate vaccine (PCV13) from the Turkish drug regulatory authority, confirming that the production facilities, processes, quality control, and quality management systems comply with Turkey's stringent drug production quality management standards [2] Company Expansion - The company has been continuously advancing its overseas business expansion, having reached cooperation agreements with over ten countries regarding the registration, promotion, commercialization, and technology transfer of products such as PCV13, PPSV23, varicella live attenuated vaccine, and quadrivalent vaccine [3] - The first batch of PCV13 finished products is expected to be successfully exported to Indonesia by August 2024. The recent GMP certification from Turkey signifies that the product is now eligible for entry into the Turkish market, which may further open up the international market for PCV13 and contribute to the company's overseas revenue growth [3] Sales Performance - In Q1 2025, the company achieved operating revenue of 645 million yuan, a year-on-year increase of 42.85%. The net profit attributable to the parent company was 22 million yuan, a year-on-year decrease of 58.51%. The net profit excluding non-recurring gains and losses was 17 million yuan, a year-on-year increase of 17.56%. The revenue and net profit excluding non-recurring items increased mainly due to steady sales of PCV13 and hepatitis B vaccines, along with contributions from new products such as human diploid rabies vaccine and varicella vaccine [4] - The decline in net profit attributable to the parent company was primarily due to a decrease in non-recurring gains such as government subsidies [4] Future Outlook - The company is optimistic about maintaining steady growth in performance driven by the sales of conventional vaccine products in the second half of the year, as it actively strengthens terminal sales and optimizes channel inventory while promoting the market entry of new products [4] - The company forecasts operating revenues of 2.963 billion yuan, 3.446 billion yuan, and 3.816 billion yuan for 2025 to 2027, representing year-on-year growth rates of 11.8%, 16.3%, and 10.8%, respectively. The net profit attributable to the parent company is expected to be 209 million yuan, 381 million yuan, and 526 million yuan, with corresponding year-on-year growth rates of 3.4%, 82.6%, and 38.3% [5]

Investment Rating - The report does not explicitly state an investment rating for the vaccine industry Core Insights - The overall trend in the vaccine industry shows a decline in batch approvals for most vaccine types in Q1 2025, with some exceptions showing recovery or growth in demand [7][29][46] Summary by Category Multi-Component Vaccines - In Q1 2025, multi-component vaccines saw a total of 17 batch approvals, a decrease of 26% compared to the previous year [11][15] - The five-component vaccine maintained its batch approval at 17, while the four-component vaccine had no approvals [15][12] Pneumonia Vaccines - Total batch approvals for pneumonia vaccines in Q1 2025 were 23, down 30% year-on-year [19][21] - The 13-valent pneumonia vaccine had 19 approvals, remaining stable, while the 23-valent vaccine saw a significant drop to 4 approvals, down 71% [24][19] HPV Vaccines - HPV vaccine approvals increased to 57 batches in Q1 2025, a growth of 63% [29][27] - The two-valent HPV vaccine saw a remarkable increase of 367%, with all approvals coming from Wantai Biological Pharmacy [29][32] Influenza Vaccines - Influenza vaccine approvals totaled 29 batches, a significant increase of 263% year-on-year [34][38] - The three-valent influenza vaccine had 28 approvals, while the four-valent vaccine had only 1 approval, down 67% [38][41] Rabies Vaccines - Batch approvals for rabies vaccines increased to 223 in Q1 2025, a growth of 37% [46][48] - The freeze-dried rabies vaccine accounted for the majority of approvals, with Chengda Biological achieving 105 approvals, a 110% increase [48][46] Varicella Vaccines - Varicella vaccine approvals slightly decreased to 83 batches, down 2% [53][54] - The largest contributor was Baike Biological, with 33 approvals, marking a 38% increase [54][53] Hib Vaccines - Hib vaccine approvals fell to 7 batches, a decrease of 50% [59][58] EV71 Vaccines - EV71 vaccine approvals continued to decline, with only 4 batches approved, down 69% [64][63] Rotavirus Vaccines - Rotavirus vaccine approvals totaled 21 batches, a decrease of 46% [68][67] DTP Vaccines - DTP vaccine approvals increased to 18 batches, a growth of 167% [72][73] Meningitis Vaccines - Meningitis vaccine approvals totaled 85 batches, down 34% [78][79] - The AC polysaccharide vaccine accounted for 55 approvals, a decrease of 47% [84][79] Hepatitis B Vaccines - Hepatitis B vaccine approvals increased to 87 batches, a growth of 28% [91][90] IPV Vaccines - IPV vaccine approvals totaled 22 batches, a decrease of 33% [93][92]

Industry Overview - The vaccine industry is experiencing a significant decline in 2024 and the first quarter of 2025, with total revenue dropping from 1,637 billion in 2023 to 1,283 billion in 2024, marking a year-on-year decrease of 21.6%, the first negative growth in five years [1] - Net profit in the industry has decreased from a peak of 309 billion in 2021 to 120 billion in 2024, a reduction of 61%, with profit margins declining from 21.7% in 2021 to 9.4% in 2024, indicating increased cost pressures [1] Company Performance - Leading companies show significant performance divergence; TianTan Bio and Tibet Pharmaceutical have reported growth, with TianTan Bio achieving 60 billion in revenue for 2024, a 17.6% increase, and a net profit of 15 billion, up 36.4% [3] - In contrast, Zhifei Biological and Wantai Biological have faced substantial declines due to intensified competition in the HPV vaccine market, with Zhifei's revenue plummeting from 529 billion in 2023 to 260 billion in 2024, a 50.8% drop, and net profit falling from 80 billion to 20 billion, a 75% decrease [3] - Wantai Biological's net profit decreased from 47 billion in 2022 to approximately 1 billion in 2024, with a drop in gross margin from 89% to 66% [3] Cost and Profitability Trends - The median sales expense ratio in the industry has increased from 48% in 2020 to 58% in 2024, with over half of the companies exceeding a 50% expense ratio [3] - Changchun High-tech's sales expense ratio rose from 44% in 2023 to 57% in 2024, with net profit margin declining from 31% to 18.7% [3] - Kanghua Biological maintained a high gross margin of 93%, but its expense ratio increased from 47% to 54%, leading to a decrease in net profit margin from 33% to 21% [3] Vaccine Approval Trends - In 2024, most vaccine varieties saw a decline in batch approvals, with Zhifei Biological's HPV vaccines experiencing significant drops in approvals, including a 95% decrease for the four-valent HPV vaccine [4] - The first quarter of 2025 showed a mixed performance in vaccine approvals, with the recombinant herpes vaccine seeing a 54% decline in batch approvals, while the two-valent HPV vaccine saw a 367% increase [4] Specific Vaccine Performance - Rabies vaccines showed good overall approval growth, with Vero cell rabies vaccines achieving 199 batch approvals, a 24% increase [5] - The flu vaccine approvals in the first quarter of 2025 saw a significant increase of 500%, with the three-valent flu vaccine experiencing a 1300% increase in approvals [5] - The 13-valent pneumonia vaccine approvals remained stable, while the 23-valent pneumonia vaccine saw a 71% decline [5]

Core Viewpoint - The Chinese vaccine industry is facing unprecedented challenges in 2024, with significant declines in market value and vaccine issuance, leading to a search for recovery strategies amidst a harsh environment [1] Group 1: Market Dynamics - The total market value of 11 A-share vaccine companies is less than the peak value of Zhifei Biological three years ago [1] - The issuance of HPV vaccines has plummeted by over 60%, while flu and rabies vaccines are embroiled in price wars [1] - The strategy of "exchanging price for volume" has failed, leading to high inventory pressures and cash flow issues for companies [1] Group 2: Structural Challenges - The industry faces a dual challenge of oversupply in low-end markets and a lack of high-end products, with over 10 companies competing in the rabies and flu vaccine markets [2] - High-end vaccines like shingles and multi-valent vaccines are still dominated by foreign companies such as GSK [2] - Companies are caught in a dilemma of high R&D costs, long return cycles, and rapid market changes [2] Group 3: Strategies for Survival - Companies are increasing investment in multi-valent vaccines, with Watson Bio and Kangtai Bio leading the charge [3] - Zhifei Biological is building a product matrix to reduce dependency on single products, while Kangtai Bio is developing 13 pipeline products [3] - Collaborations for international market access, such as Kanghua Bio's partnership with HilleVax, are emerging as a survival strategy for smaller firms [3] Group 4: Future Outlook - The current dark period for the vaccine industry may serve as a starting point for value reassessment [4] - Companies that possess strong technology, diverse product portfolios, and global market access are likely to survive the supply-side cleansing [4] - The potential for Chinese vaccine companies to develop world-class products will determine the industry's future [4]