Bayer, Merck & Co., and Harbour BioMed Announce Latest Financial Results; Hengrui Medicine Enters Global Collaboration with GSK on Up to 12 Innovative Therapies

Author: Interns Chen Chuan, Zheng Ao, He Duo

BeOne Medicines' PD-1 Inhibitor Receives Positive CHMP Recommendation in the EU

On July 28, BeOne Medicines announced that its PD-1 inhibitor, BeiGene's Baizean® (tislelizumab), received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), recommending approval for perioperative treatment of patients with resectable non-small cell lung cancer (NSCLC). The regimen includes neoadjuvant chemotherapy combined with surgery and adjuvant monotherapy post-surgery. It has the advantages of significantly improving the pathological complete response (pCR) rate, markedly enhancing the major pathological response rate, and demonstrating a favorable safety profile.

BeOne Medicines/Amgen Initiate Tarlatamab Phase III Clinical Trial

On July 28, BeOne Medicines and Amgen announced the initiation of a Phase III clinical trial for Tarlatamab (Taladotamab) in China, targeting untreated patients with extensive-stage small cell lung cancer (ES-SCLC). The study will evaluate the efficacy and safety of Tarlatamab in combination with Durvalumab and chemotherapy.

Tarlatamab is a bispecific antibody targeting DLL3/CD3. Previous global Phase III studies have shown that it can significantly improve overall patient survival. On July 16, 2025, the drug's marketing application in China was accepted and included in the priority review.

Innovent Bio Initiates Phase II Clinical Trial of IBI363 in Neoadjuvant Treatment for Lung Cancer

On July 30, Innovent Bio announced the launch of a Phase II clinical study of IBI363 (PD-1/IL-2 bispecific antibody) for neoadjuvant treatment of non-squamous non-small cell lung cancer. The study will evaluate the efficacy and safety of IBI363 in combination with chemotherapy or pembrolizumab in combination with chemotherapy.

IBI363 is an innovative PD-1/IL-2 bispecific antibody drug. Clinical data presented at the 2025 ASCO Annual Meeting demonstrated its therapeutic potential across multiple tumor types. This study plans to enroll 170 patients and is jointly led by Professor Jianxing He and Professor Hongxu Liu.

Akeso's New Indication Application for Eftilagimod Alpha Accepted for Review

On July 28, Akeso announced that the marketing application for its self-developed PD-1/VEGF bispecific antibody, Ivonescimab (trade name: Yidafang®), in combination with chemotherapy as a first-line treatment for squamous non-small cell lung cancer (sq-NSCLC), has been accepted by the National Medical Products Administration. The application is based on positive results from a Phase III clinical study, which demonstrated that Ivonescimab combined with chemotherapy is superior to PD-1 monotherapy combined with chemotherapy.

Ivonescimab is the world's first approved PD-1/VEGF bispecific antibody, which was approved in May 2024 for nsq-NSCLC patients who failed EGFR-TKI treatment and included in the national medical insurance catalog in the same year. Currently, the drug is undergoing Phase III clinical trials for 18 indications.

Betta Pharmaceuticals Initiates Phase II Clinical Study of MCLA-129 for Lung Cancer

On July 29, Betta Pharmaceuticals announced that the first patient has been enrolled in the Phase II clinical study of its self-developed EGFR/c-Met bispecific antibody MCLA-129 for driver gene-positive and MET-amplified non-small cell lung cancer (NSCLC).

MCLA-129 is an innovative bispecific antibody that simultaneously targets the EGFR and c-Met signaling pathways and enhances anti-tumor activity by strengthening the ADCC effect. In November 2024, the drug was approved by the National Medical Products Administration (NMPA) for clinical trials in advanced solid tumors.

3SBIOINC's PD-1/PD-L1 Bispecific Antibody Approved for Two Phase II Clinical Trials

On July 29, 3SBIOINC announced that its self-developed PD-1/PD-L1 bispecific antibody SSGJ-706 had been approved by the National Medical Products Administration to conduct two Phase II clinical trials, targeting patients with advanced digestive system tumors and non-small cell lung cancer respectively.

SSGJ-706 is a tetravalent bispecific antibody developed based on 3SBIOINC's CLF2 patent platform, which can simultaneously target PD-1 and PD-L1. Phase I clinical studies have confirmed its good safety. Two Phase II studies will adopt a basket trial design, covering multiple tumor types.

GenFleet Therapeutics' KRAS G12D Inhibitor Granted FDA Fast Track Designation

On July 25, GenFleet Therapeutics announced that its oral KRAS G12D inhibitor GFH375/VS-7375 received Fast Track designation from the U.S. FDA for the treatment of locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) with KRAS G12D mutations.

GFH375/VS-7375 is an orally administered small molecule inhibitor targeting the KRAS G12D mutation. It received clinical approval in China in June 2024 and has entered Phase II research. Its Phase I/IIa study in the United States is being advanced by its partner, Verastem Oncology.

Harbour BioMed Announces Profit Increase for the First Half of 2025

On July 27, Harbour BioMed announced a positive profit forecast for the first half of 2025, with an expected profit of $68 million to $74 million. The growth in performance is mainly attributed to strategic cooperation with global pharmaceutical companies such as AstraZeneca, as well as the continued increase in revenue from innovative product licensing. This profit increase reflects the effectiveness of the company's strategic layout in the global biopharmaceutical field.

Hengrui Pharma and GSK Reach Global Development Collaboration for 12 Innovative Drugs

On July 28, Hengrui Pharma announced a strategic collaboration agreement with GSK. The two parties will jointly develop up to 12 innovative drugs across the fields of respiratory, autoimmune and inflammatory diseases, and oncology treatment. According to the agreement, GSK will pay Hengrui Pharma an upfront payment of 500 million US dollars.

This collaboration includes the global (excluding China) exclusive rights authorization for HRS-9821, a PDE3/4 inhibitor independently developed by Hengrui Pharma. The drug is currently in the clinical development stage and is mainly used for the treatment of chronic obstructive pulmonary disease (COPD).

WuXi Biologics Singapore Modular Biologics Manufacturing Facility Breaks Ground

On July 29, WuXi Biologics announced the official start of construction for its modular biologics manufacturing facility at its Singapore CRDMO center. The project adopts an innovative modular construction approach, with 470 main modules currently being manufactured in Changshu, China. Once completed, they will be transported to the Tuas Biomedical Park in Singapore for assembly.

According to official disclosure, the production base has a total construction area of 30,000 square meters, with plans to construct five modern production lines (including three pre-filled syringe production lines and two vial production lines). It will fully adopt a green energy technology system and is expected to officially commence operations in 2027.

AbbVie Submits Supplemental New Drug Application for VENCLEXTA® in Combination with Acalabrutinib for Previously Untreated CLL Patients

On July 29, AbbVie announced that it had submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of VENCLEXTA® (venetoclax) in combination with acalabrutinib for previously untreated chronic lymphocytic leukemia (CLL) patients. This all-oral, fixed-duration combination regimen is expected to provide a new treatment option for CLL patients.

This application is based on the positive results of the Phase 3 AMPLIFY clinical trial. The data showed that VENCLEXTA in combination with acalabrutinib significantly improved progression-free survival (PFS) in treatment-naïve CLL patients compared to standard chemoimmunotherapy.

"This application marks an important advancement in the field of CLL treatment," said Svetlana Kobina, Vice President of Global Oncology Medical Affairs at AbbVie. "This fixed-duration regimen has the potential to transform current first-line treatment practices for CLL."

Roche's Alzheimer's Disease R&D Pipeline Achieves Significant Progress

On July 28, Roche announced its latest research findings in the field of Alzheimer's disease diagnosis and treatment at the Alzheimer's Association International Conference (AAIC). In terms of treatment, Roche presented positive data from the Phase Ib/IIa Brainshuttle™ AD study on trontinemab, confirming that the drug can rapidly and significantly reduce amyloid plaques in the brain. The company plans to initiate two Phase III TRONTIER studies within the year and add another Phase III study targeting high-risk preclinical populations.

In terms of diagnostic technology, Roche highlighted the Elecsys® pTau217 blood test, which received FDA Breakthrough Device Designation in 2024 as a reliable blood biomarker for amyloid pathology.

"Breakthrough progress is needed in the diagnosis and treatment of Alzheimer's disease," said Dr. Levi Garraway, Global Chief Medical Officer of Roche, "We believe the combination of trontinemab with advanced diagnostic technologies will provide patients with earlier and more effective intervention options."

Bayer's HER2-Targeted Drug Submitted for Marketing Approval in China

On July 28, 2025, Bayer announced that the CDE had accepted the marketing application in China for its oral TKI drug sevabertinib, intended for the treatment of previously treated HER2-mutant advanced non-small cell lung cancer. This drug is expected to provide a new treatment option for this difficult-to-treat patient population.

Eli Lilly's New Diabetes Drug Approved for Additional Indication in China

On July 28, Eli Lilly announced that its GLP-1 receptor agonist Mounjaro® (tirzepatide) received NMPA approval for a new indication, which can be used in combination with insulin to treat adult patients with type 2 diabetes. Clinical studies have shown that this combination regimen significantly improves blood glucose control while reducing insulin dosage and body weight without increasing the risk of hypoglycemia.

As the country with the largest number of patients with type 2 diabetes globally, this approval will provide a better option for patients who have had poor responses to insulin treatment. Mounjaro® has previously been approved for monotherapy in type 2 diabetes.

Eli Lilly Announces Long-Term Efficacy Data of Innovative Alzheimer's Disease Drug

On August 1, Eli Lilly announced that the three-year long-term extension study data of its innovative Alzheimer's disease drug Donanemab Injection (brand name: Jinenada®) was presented at the Alzheimer's Association International Conference (AAIC). The study showed that, compared to the delayed treatment group, early treatment with Jinenada® reduced the risk of Alzheimer’s disease progression by 27%, and more than 75% of patients achieved amyloid plaque clearance within 76 weeks. This makes it the first Alzheimer’s treatment in China to demonstrate significant benefits from early intervention.

Bayer Raises 2025 Performance Forecast and Adds New Litigation in the U.S.

On July 31, Bayer AG released its Q2 2025 business update. The report showed that the group achieved sales of 10.7 billion euros this quarter, with adjusted EBITDA reaching 2.1 billion euros. Due to the outstanding performance of its pharmaceuticals business, Bayer raised its full-year guidance, expecting group sales to reach 46-48 billion euros, with core EPS forecast revised upward to 4.80-5.30 euros. Meanwhile, Bayer announced an additional litigation provision of 1.7 billion euros for handling glyphosate and PCB-related lawsuits. Currently, the company has resolved 131,000 drafted glyphosate claims. Affected by currency fluctuations, total annual sales are expected to decrease by 2 billion euros. The full quarterly financial report will be published on August 6.

MSD Announces Q2 2025 Financial Results

On July 29, MSD announced its financial results for the second quarter of 2025. The report showed that the company achieved global sales of $15.8 billion in this quarter, of which the star anti-cancer drug KEYTRUDA® (Pembrolizumab) generated sales of $8 billion, a year-on-year increase of 9%, continuing to lead the global oncology drug market.

In the announcement, Merck unveiled a multi-year optimization plan covering multiple business areas, which is expected to save approximately $3 billion annually by the end of 2027. These funds will be entirely reinvested into strategic growth areas to drive long-term corporate transformation. Meanwhile, the company is investing $1 billion in the construction of a new biologics center in the United States to support the commercial production of KEYTRUDA®.

Novo Nordisk Appoints New CEO and Restructures R&D Department

On July 29, Novo Nordisk announced a senior management change in the company, with Maziar Mike Doustdar becoming the new President and Chief Executive Officer.

Downgrade of Performance Expectations: Novo Nordisk lowered its 2025 performance forecast due to a slowdown in sales growth of its core product, semaglutide (Wegovy and Ozempic), causing an 21.83% drop in stock price.

Novo Nordisk has decided to merge the company's research and early development with its development areas into a new integrated R&D department, led by Martin Holst Lange, MD, PhD. Martin Holst Lange, current Executive Vice President of Development, will be appointed as Chief Scientific Officer (CSO), effective August 7.

Boehringer Ingelheim and Re-Vana Therapeutics Announce Strategic Collaboration to Develop Long-Acting Ophthalmic Therapies

On July 30, Boehringer Ingelheim announced a strategic partnership with Re-Vana Therapeutics to jointly develop long-acting ophthalmic therapies. Re-Vana's sustained-release technology can reduce the frequency of intravitreal injections from once a month to once every 6-12 months, which is expected to significantly improve patient compliance.

Under the agreement, Boehringer Ingelheim will add up to 3 collaborative projects annually, taking charge of clinical development and global commercialization. Re-Vana will receive milestone payments exceeding 1 billion US dollars as well as sales royalties. This collaboration will combine Boehringer Ingelheim's four Phase II ophthalmology pipelines with Re-Vana's sustained-release platform to develop breakthrough therapies for retinal diseases.

Sanofi Acquires China Rights to Small Nucleic Acid Drug

On August 1, Sanofi announced an agreement with Viya Zhen to obtain the development and commercialization rights of the RNA interference (RNAi) therapy volanesorsen sodium injection in Greater China. This drug is the first-of-its-kind APOC3-targeted therapy intended for the treatment of familial chylomicronemia syndrome (FCS) and severe hypertriglyceridemia (SHTG).

Plecanatide sodium, developed by Arrowhead Pharmaceuticals, reduces APOC3 protein expression through RNA interference technology and is currently undergoing clinical research in multiple regions worldwide. This collaboration will further enrich Sanofi's cardiometabolic disease pipeline in the Chinese market.

Bristol-Myers Squibb and Bain Capital Establish New Immunotherapy Company

On July 28, Bristol-Myers Squibb announced the joint establishment of a biopharmaceutical company focused on autoimmune disease treatment with Bain Capital. The new company’s initial assets consist of five immunology R&D programs licensed from BMS and have secured a $300 million financing commitment led by Bain Capital.

The new company covers three drugs in clinical trial stages and two preparing to enter Phase I clinical trials, including: TLR7/8 inhibitor Afimetoran, TYK2 inhibitor BMS-986322, IL-2 fusion protein BMS-986326, IL-8 targeted BMS-986481, and IL-10 targeted BMS-986498.

Biopharma veteran Daniel S. Lynch will serve as Executive Chairman and interim CEO. Dr. Nicholas Downing, Dr. Adam Koppel, and Andrew Kaplan from Bain Capital will join the board of directors, leading the company alongside Mr. Lynch and Dr. Plenge.