VCBeat Pharma Weekly | new BI China leadership, a Fosun-Pfizer deal, and major clinical updates

Clinical Progress

Eli Lilly's innovative drug pirtobrutinib achieves primary endpoint in world's first head-to-head Phase III study vs. ibrutinib

On December 7, Eli Lilly announced new results from the Phase III BRUIN CLL-314 clinical trial. This study aimed to evaluate the efficacy of the non-covalent (reversible) BTK inhibitor Jaypirca® (pirtobrutinib) compared to the covalent BTK inhibitor Imbruvica® (ibrutinib) in patients with treatment-naïve or previously untreated (without prior BTK inhibitor therapy) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The results showed that in the intent-to-treat (ITT) population, pirtobrutinib met the primary endpoint of non-inferiority in overall response rate (ORR) and was numerically superior to ibrutinib.

Eli Lilly's innovative drug pirtobrutinib significantly prolongs progression-free survival in treatment-naïve CLL/SLL patients

On December 9, Eli Lilly announced new results from the Phase III BRUIN CLL-313 clinical trial. This study aimed to evaluate the efficacy and safety of the non-covalent BTK inhibitor Jaypirca® (pirtobrutinib) versus bendamustine plus rituximab (BR) in treatment-naïve patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletion. The results showed that pirtobrutinib reduced the risk of disease progression or death by 80% (HR=0.20, [95% CI, 0.11-0.37]; p<0.0001), meeting the primary endpoint.

Novartis discloses Phase III clinical trial results for a BAFF-R monoclonal antibody

On December 9, Novartis disclosed detailed data from the Phase III VAYHIT2 clinical trial evaluating its BAFF-R monoclonal antibody as a second-line treatment for primary immune thrombocytopenia (ITP). VAYHIT2 is a Phase III clinical trial designed to assess the efficacy of ianalumab combined with eltrombopag in patients with primary immune thrombocytopenia (ITP) who had previously received glucocorticoid therapy. For the primary endpoint—time to treatment failure (TTF)—treatment with ianalumab (9 mg/kg) combined with eltrombopag prolonged disease control time in ITP by 45%. Novartis plans to submit data from the second-line ITP VAYHIT2 trial, along with results from the ongoing first-line ITP VAYHIT1 trial, to health regulatory authorities in 2027.

New Approvals

Roche's Gazyvaro has received European Union approval for the treatment of lupus nephritis

On December 9, Roche announced on its official website that the European Commission has approved Gazyvaro (obinutuzumab) in combination with standard therapy for the treatment of adult patients with lupus nephritis (LN). This marks the first new indication for Gazyvaro in the European Union. Previously, the drug received a similar approval in the United States, where it is marketed under the brand name Gazyva through a collaboration between Roche and Biogen.

The U.S. FDA has granted Priority Review designation to a monoclonal antibody combination therapy developed by BMS

On December 11, Bristol Myers Squibb (BMS) announced on its official website that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a supplemental Biologics License Application (sBLA) for Opdivo®. The application seeks approval for Opdivo in combination with doxorubicin, vinblastine, and dacarbazine (the AVD regimen) for the treatment of previously untreated adult and pediatric patients (aged 12 years and older) with Stage III or IV classical Hodgkin lymphoma (cHL).

Transaction Trends

Johnson & Johnson invests $40 Million in a cell therapy company

On December 9, Cellular Origins, a biotechnology company dedicated to cell therapy and part of the TTP Group, announced the completion of an oversubscribed $40 million (approximately €34.3 million) Series A financing round. This round was led by Johnson & Johnson through its corporate venture capital arm, Johnson & Johnson Innovation – JJDC, Inc., with participation from Highland Europe, BGF, NYBC Ventures, and the TTP Group.

The new funds will be used by Cellular Origins to expand its commercial team, integrate more resources into its Constellation platform, and develop the infrastructure required for large-scale global production. Cellular Origins also plans to extend its technology to the broader field of Advanced Therapy Medicinal Products (ATMPs), an area that continues to face similar scale-up challenges.

Executive Moves

Boehringer Ingelheim appoints new Head of Greater China

On December 10, Boehringer Ingelheim announced that Dr. Ioannis Sapountzis will assume the role of Head of Greater China effective March 1, 2026. The current Head of Greater China, Mohammed Tawil, will transition to the position of Head of Human Pharmaceuticals for Emerging Markets. This adjustment aims to drive the independent development of the Greater China region, accelerate business growth, and integrate a China perspective into the core of the company's global strategy.

Clinical Progress

Zai Lab initiates global Phase I/Ib clinical trial for bispecific antibody ZL-1503

On December 8, Zai Lab announced the completion of the first patient dosing in the global Phase I/Ib clinical trial of its self-developed IL-13/IL-31R bispecific antibody, ZL-1503, for the treatment of atopic dermatitis. The study aims to evaluate the drug's safety and efficacy. Its dual-targeting strategy holds the potential to provide superior efficacy for patients with moderate-to-severe disease.

Innovent Biologics' picankibart achieves endpoints in a new Phase III clinical study

On December 9, Innovent Biologics announced on its official website that its self-developed recombinant anti-interleukin-23p19 (IL-23p19) monoclonal antibody injection, picankibart (R&D code: IBI112), met both the primary and key secondary efficacy endpoints in the CLEAR-2 study. This is a randomized withdrawal and retreatment Phase III clinical trial conducted in Chinese subjects with moderate-to-severe plaque psoriasis. As the first China-discovered IL-23p19 monoclonal antibody, Xinmeiyue® (picankibart) received approval from the National Medical Products Administration (NMPA) in November 2025 for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.

Akeso's international Phase III trial for PD-1/CTLA-4 bispecific antibody combination therapy in gastric cancer receives FDA approval

On December 12, Akeso announced that its global first-in-class PD-1/CTLA-4 bispecific antibody, cadonilimab, has received approval from the U.S. Food and Drug Administration (FDA) to proceed with the international multi-center Phase III clinical study (COMPASSION-37/AK104-311). The study will evaluate cadonilimab combined with chemotherapy versus chemotherapy with or without nivolumab as first-line treatment for patients with HER2-negative, previously untreated unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.

Innovent Biologics' mazdutide reaches primary endpoint in Phase Ib Study in Chinese adolescent obesity population

On December 12, Innovent Biologics announced on its official website that mazdutide injection (a glucagon (GCG)/glucagon-like peptide-1 (GLP-1) dual receptor agonist, R&D code: IBI362) has achieved the primary endpoint in a Phase Ib clinical trial conducted in a Chinese adolescent obesity population.

Innocare Pharma announces orelabrutinib meets primary endpoint in Phase IIb study for systemic lupus erythematosus

On December 14, Innocare Pharma announced that its self-developed novel Bruton's tyrosine kinase (BTK) inhibitor, orelabrutinib, has met the primary endpoint in a Phase IIb clinical trial for the treatment of systemic lupus erythematosus (SLE). Concurrently, the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved the initiation of a Phase III registration clinical trial. The Phase IIb results demonstrated that orelabrutinib exhibited excellent efficacy, along with favorable tolerability and safety profiles, in patients after 48 weeks of treatment.

New Approvals

Two new indications of aumolertinib mesilate tablets Included in National Reimbursement Drug List 2025, multiple innovative drugs successfully retained

On December 7, Hansoh Pharma announced that two new indications of its innovative drug aumolertinib mesilate tablets have been successfully included in the National Reimbursement Drug List (NRDL) 2025. Additionally, all indications of Sheng Luolai® (pegmolesatide injection) and Hengmu® (tenofovir amibufenamide tablets) have been renewed in the 2025 NRDL. The updated national reimbursement drug list will take effect on January 1, 2026.

Collaboration Development

Fosun Pharma's subsidiary Yao Pharma enters exclusive collaboration and license agreement with Pfizer for GLP-1 Drug YP05002

On December 9, Fosun Pharma announced that its controlled subsidiaries, Yao Pharma and Fosun Pharma Industrial, have entered into a License Agreement with Pfizer Inc. Under the agreement, Yao Pharma has granted Pfizer exclusive global rights to develop, use, manufacture, and commercialize oral small molecule glucagon-like peptide-1 receptor (GLP-1R) agonists, including YP05002, and any products containing this active ingredient. The licensed scope covers treatment, diagnosis, and prevention for all human and veterinary indications.

Everest Medicines and Hasten Biopharmaceutical form strategic collaboration, securing commercialization rights for multiple products and license for cardiovascular novel drug

On December 11, Everest Medicines and Hasten Biopharmaceutical entered into two strategic collaborations. The first involves Everest Medicines providing commercialization services for six of Hasten Biopharmaceutical's established products. The second grants Everest Medicines exclusive development and commercialization rights for the novel PCSK9 inhibitor lerodalcibep in Greater China. These initiatives aim to enhance the efficiency of Everest Medicines' commercialization platform and accelerate its strategic expansion in the cardiovascular business.