Pfizer, Bayer, and Novo Nordisk Announce Latest Financial Results; Sanofi Confirms Praluent Has Exited the Chinese Market | Arterial Weekly Report

Author: Wu Yinggang, Interns He Duo, Chen Chuan, Zheng Ao

1. Dynamics of Pharmaceutical Companies in China

Luye Pharma Initiates Phase I Clinical Trial in China for First-in-Class Antidepressant Innovation

8On the 3rd, Luye Pharma Group announced that the Phase I clinical trial of its self-developed Class 1 innovative drug LY03021 conducted in China has completed the enrollment of the first healthy subject. The study aims to evaluate the safety, tolerability, and pharmacokinetic characteristics of LY03021.

LY03021It is a novel antidepressant drug with "First-in-Class" potential, utilizing a unique triple-target mechanism of action: simultaneously inhibiting the norepinephrine transporter (NET) and dopamine transporter (DAT), while positively modulating gamma-aminobutyric acid A receptor (GABAAR). This design aims to rapidly improve depressive symptoms (non-clinical studies show effectiveness within 24 hours of administration) and, by regulating the balance of neurotransmitters in the brain, reduce the risk of common adverse effects such as excessive sedation associated with traditional GABAAR-targeted drugs, thereby enhancing treatment safety.

Abogen's mRNA Therapeutic Cancer Vaccine Approved for Clinical Trials, Achieving Dual Filing and Dual Approval

8On the 4th, according to the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration, the new drug clinical trial (IND) application for Abogen's self-developed novel mRNA cancer vaccine ABO2102, which simultaneously covers multiple KRAS mutations, has received clinical tacit approval. As the first therapeutic cancer vaccine in China targeting multiple KRAS mutations, ABO2102 is applicable to solid tumor patients carrying any of the five common KRAS mutations. This marks a significant advancement in the highly challenging field of difficult-to-drug targets.

ABO2102It has received clinical trial approval from the U.S. Food and Drug Administration (FDA) in May this year. This recent approval in China marks an important milestone for ABO2102, achieving dual submissions and approvals in both China and the United States, fully demonstrating Abogen's globally leading innovation capabilities and international layout in the field of cancer immunotherapy.

Akeso's Cadonilimab for IO-Resistant HCC International Multicenter Registrational Clinical Trial Initiated

8On August 4, Akeso announced that its self-developed, world's first PD-1/CTLA-4 bispecific antibody Cadonilimab (Kaitanli®), in combination with Lenvatinib versus Lenvatinib for the treatment of advanced hepatocellular carcinoma (HCC) patients who have previously received Atezolizumab (PD-L1) in combination with Bevacizumab, has been approved by the China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) for a randomized controlled, international multi-center registrational Phase II clinical study (COMPASSION-36/AK104-225). The company is currently advancing the implementation of this study.

This study is the first registrational international multicenter clinical trial of Cadonilimab, which will significantly accelerate the process of Cadonilimab's global market expansion and substantially enhance its global clinical and commercial value.

HEC CJ PHARM Files for Clinical Trial of HBV siRNA New Drug in China 

8On the 4th, HEC Pharm announced that its independently developed hepatitis B small nucleic acid innovative drug HECN30227 has officially submitted an Investigational New Drug (IND) application to Chinese regulators. As China's first siRNA therapy targeting the hepatitis B virus (HBV), this drug is expected to break through existing treatment bottlenecks and offer new hope for "functional cure" to nearly 70 million Chinese patients with chronic hepatitis B.

HECN30227Precisely degrades HBV RNA through gene silencing mechanisms, effectively suppressing the expression of hepatitis B surface antigen (HBsAg). Preclinical studies demonstrate its potent, long-lasting, and pan-genotypic antiviral activity. This drug utilizes HEC Pharm's proprietary HEC-GalNova liver-targeting delivery system, significantly enhancing efficacy while reducing off-target risks. Currently, no similar therapies have been approved globally, and HECN30227 exhibits "best-in-class" potential with its differentiated advantages.

Innovent Bio's Oral Small Molecule GLP-1R Agonist IBI3032 Receives FDA IND Approval

8On the 5th of the month, Innovent Bio announced that its innovative oral small molecule GLP-1R agonist IBI3032 received approval for a new drug clinical trial application (IND) from the U.S. Food and Drug Administration (FDA). IBI3032 is an orally administered small molecule GLP-1R agonist independently developed by Innovent Bio, based on globally validated molecular scaffolds and with full independent intellectual property rights. Preclinical data show that it has superior PK and physicochemical properties compared to similar products. In animal models, the oral exposure at the same dose was 5 to 10 times higher than that of similar products, demonstrating better efficacy in mouse models and obese cynomolgus monkeys, with good tolerability and equivalent potency achieved at lower doses.

IBI3032The Phase I clinical trial will be advanced simultaneously in China and the United States, with dosing expected to begin in healthy subjects and overweight or obese populations in the second half of 2025. Innovent Bio is rapidly expanding its metabolic pipeline with Mastyde peptide as the cornerstone, and the initiation of the IBI3032 clinical study marks an important step in the evolution of its metabolic product portfolio.

Frontier Biotech's Far-Infrared Treatment Patch Obtains Dual Medical Device Certifications

8On July 7, Frontier Biotech announced that its novel hot-melt adhesive far-infrared treatment patch simultaneously obtained the Medical Device Production License and registration certificate (Shandong Approval No. 20252090416) issued by the Shandong Provincial Medical Products Administration. As a Class II medical device, this product is suitable for the adjuvant treatment of pain associated with cervical spondylosis, periarthritis of the shoulder, and other conditions. Its medical-grade hot-melt adhesive technology offers advantages such as low allergenicity and invisible application, significantly improving patient experience.

The approval of the dual certifications marks the company's comprehensive establishment of an "R&D-production-commercialization" full-chain capability, clearing access barriers for products to enter medical institutions and retail terminals. Facing a far-infrared treatment patch market exceeding 30 billion yuan in scale, the company will use innovation as its driving force, continuously advancing the development of a series of patch agents in the pain management field, while accelerating product commercialization based on a standardized quality management system.

Ribo Life Science Raises Over 200 Million Yuan in New Round of Financing, Led by Mingxin Capital

Suzhou Ribo Life Science Co., Ltd. announced that it has recently completed a new round of private equity financing exceeding 200 million RMB. This round of financing was led by Mingxin Capital, with participation from Kunshan High-Tech Venture Capital, Kunshan Guoke Venture Capital, Chouqin Venture Capital, Panlin Capital, Langma Peak Venture Capital, and Shenzhen Xinchuang Yihuo, among other well-known investment institutions. The proceeds from this financing will mainly be used to accelerate the advancement of the company's self-developed clinical pipelines in the treatment areas of cardiovascular, metabolic, renal, and liver diseases, deepen the innovation and product development of its extrahepatic delivery technology platform, and strengthen the construction of global R&D and industrial capabilities.

Everest Medicines Announces Increased Strategic Investment in I-Mab to Develop Global Value of Next-Generation Self-Developed Cancer Immunotherapy

8On the 1st, Everest Medicines announced a strategic investment of $30.9 million in NASDAQ-listed I-Mab (IMAB). After the transaction, its shareholding ratio reached 16.1%, making it the largest shareholder. This move aims to integrate the core platforms of both parties: I-Mab's differentiated 4-1BB bispecific antibody pipeline (including the gastric cancer therapy Givastomig with an ORR of 83%) and Everest Medicines' AI + mRNA platform, autologous CAR-T technology to form synergies and accelerate the global development of next-generation cancer immunotherapies.

I-MabThree clinical-stage products (bispecific antibody and CD73 antibody) will benefit from the complementarity of Everest Medicines' Asian clinical resources and its U.S. development capabilities. This round of financing also attracted participation from several international institutions, including Janus Henderson, and the funds will be used to advance the joint pipeline. Everest Medicines’ investment in this round is recorded as a non-current asset and does not impact the income statement.

BeOne Medicines Announces Financial Results and Business Progress for the Second Quarter of 2025

8On August 6, BeOne Medicines announced its financial results and business progress for the second quarter of 2025. The report showed that the company's total revenue for the second quarter was $1.3 billion. Free cash flow was $220 million, an increase of $425 million compared to the same period last year. The United States remains the company's largest market, with product revenue reaching $685 million. The growth in total revenue was mainly driven by the sales growth of Brukinsa® (zanubrutinib) in the U.S. and Europe. Both GAAP and adjusted R&D expenses increased year-over-year, primarily due to higher costs from clinical-stage projects, offset by reductions in upfront payments and milestone payments during the development phase.

BeOne Medicines' Second Quarter Business Highlights: BRUKINSA® (Zanubrutinib) and Tislelizumab. BRUKINSA® has been approved in 75 markets worldwide, with reimbursement coverage newly added or expanded in 5 markets this quarter. Tislelizumab has been approved in 47 markets globally, with reimbursement newly included in 20 markets this quarter.

HEC CJ PHARM Listed on HKEX

8On July 7, Dongyangguang Pharmaceutical officially listed on the Main Board of the Hong Kong Stock Exchange, becoming the first company to achieve listing through an H-share absorption merger privatization plus introduction. The company achieved overall listing by integrating its subsidiary, HEC CJ PHARM. This transaction did not involve the issuance of new shares or fundraising, establishing a new model for capital operations on the Hong Kong Stock Exchange.

This listing marks a new journey for HEC CJ PHARM, driven by the dual engines of "innovation and internationalization," with the potential to reshape the global value benchmark for Chinese pharmaceutical companies.

• Multinational Pharmaceutical Companies' Dynamics

AstraZeneca Announces New Indication Approval for FanShuZhuo® in China

8On the 4th, AstraZeneca announced that its first respiratory biologic in China, Fasenra® (generic name: Benralizumab Injection), had been officially approved for a new indication in China for the maintenance treatment of severe eosinophilic asthma (SEA) in children aged 6 to under 12 years. Benralizumab is an anti-IL-5R biologic that precisely targets eosinophils and was previously approved in China for the maintenance treatment of SEA in adults and adolescents aged 12 years and above.

Sanofi Responds: Plavix Has Indeed Withdrawn from the Chinese Market

Recently, Sanofi has clearly stated that it will stop promoting Praluent® (Alirocumab Injection) in China, and the drug will face a supply shortage in the Chinese market. The main reasons include global supply issues as well as the company’s strategic adjustments in the cardiovascular market and pipeline optimization.

Alirocumab Injection is a PCSK9 inhibitor class lipid-lowering drug, mainly used for the prevention of cardiovascular events in patients with atherosclerotic cardiovascular disease, as well as for the treatment of primary hypercholesterolemia (including heterozygous familial and non-familial) and mixed dyslipidemia to reduce low-density lipoprotein cholesterol (LDL-C) levels.

ModernaRelease of Q2 2025 Earnings Report

8On August 1, Moderna released its Q2 2025 earnings report: quarterly revenue of $142 million (a year-over-year decrease of 41%), with a GAAP net loss of $800 million. The company updated its 2025 financial guidance: reducing the high end of its full-year revenue forecast by $300 million to $1.5-$2.2 billion, primarily due to deferred contract revenue from the UK being pushed to 2026; meanwhile, it raised its operating expense forecast by $400 million to $5.9-$6.1 billion but maintained its year-end cash balance projection at $6 billion.

Business highlights include: excellent Phase III efficacy data for seasonal influenza vaccine mRNA-1010 (26.6% relative efficacy improvement), recently receiving three new approvals from the U.S. FDA; completion of enrollment for the Phase III trial of the cancer vaccine mRNA-4157 (adjuvant treatment for melanoma) in collaboration with Merck. The company announced a global workforce reduction of 10% to optimize operational efficiency.

Pfizer Releases Q2 2025 Earnings Report, Revenue of $14.65 Billion

8On August 5, Pfizer released its Q2 financial report for 2025, showing that the company's Q2 revenue reached $14.65 billion, a year-on-year increase of 10%, with a net profit of $2.91 billion.

Pfizer Achieves Positive Progress in Q2 with COVID-19 Drugs, New Drug Sales, and Stability of Traditional Medications. Global sales of the COVID-19 vaccine Comirnaty surged by 95%, while the oral antiviral drug Paxlovid increased by 71%. In terms of new product performance, Pfizer demonstrated significant growth in the RSV vaccine Abrysvo, the anticancer drug Padcev, and the lung cancer targeted therapy Lorbrena.

Bayer Announces Q2 Financial Report

8On August 6, Bayer AG released its Q2 2025 financial report. The Q2 data shows: Group sales reached 10.739 billion euros, with Crop Science increasing by 2.2% to 4.788 billion euros, Pharmaceuticals rising by 0.6% to 4.47 billion euros, and Consumer Health growing by 0.2% to 1.427 billion euros. Core earnings per share were 1.23 euros, and free cash flow was 125 million euros.

Novo Nordisk Releases 2025 Semi-Annual Report

8June,Novo NordiskAnnouncement of 2025 First Half Results: Sales reached DKK 154.9 billion (CER growth of 18%), operating profit at DKK 72.2 billion (CER growth of 29%). Revenue in the obesity treatment sector surged 58% (CER) to DKK 38.8 billion, while GLP-1 diabetes drugs grew by 10% (CER), jointly driving overall growth.

Company Announces Major Adjustments: Maziar Mike Doustdar to Assume Role as Global President and CEO on August 7, Establishing Integrated R&D Department. Due to slower expansion in the GLP-1 market and intensifying competition, the full-year sales growth forecast is revised to 8%-14% (CER), with operating profit growth projected at 10%-16% (CER). The R&D pipeline is advancing smoothly; subcutaneous/intravenous amycretin enters Phase 3 trials, and higher-dose semaglutide has been submitted for approval in the EU.

Bayer's Dual Cases Honored on the 2025 Healthcare Sustainability Innovation List

8On the 5th, at the "AI + Healthcare Sustainable Innovation Forum" of the 2025 World Artificial Intelligence Conference, Bayer became the only company to simultaneously receive two honors. Its "Consumer Health China Collaboration and Innovation Center (CCIP)" was selected as an "International Innovation Localization Case" for its cross-disciplinary collaborative innovation model. The center has invested 20 million euros to promote the research and internationalization of self-care solutions in China. The "Green Supply Chain for Sustainable Energy Conservation and Emission Reduction" project was recognized as an "ESG Innovation Practice Case" for practices such as the green access system for prescription drugs and carbon footprint tracking at the Kunming supply center.

Bayer Continues to Advance Its Sustainable Development Strategy Through Global Projects Such as ForwardFarming; the Dual Honors This Time Highlight the Effectiveness of Its "Local Innovation + Green Transition" Dual-Drive Approach. The Company Stated That It Will Continue to Deepen Its Innovative Layout in China, Providing a Model for the Sustainable Development of the Global Health Industry.