Multinational Pharma Companies in China: Siemens Healthineers, Fresenius, Pfizer, AstraZeneca, Novartis, Takeda Highlight New Initiatives and Product Updates

(Pharmaceutical Health News, March 28, 2022)

Enterprise Dynamics

Siemens Healthineers, leveraging its advantages and experience in 5G, VR, and AI, has pioneered the launch of an "immersive teaching" solution in the industry. Relying on cutting-edge digital technology, it has created a human-computer interactive, remote hands-on, convenient, and flexible learning tool for imaging technicians, empowering the enhancement of medical professionals' skills and diagnostic capabilities. Siemens Healthineers provides students with three major virtual reality teaching tools that integrate online and offline learning: the 5G Virtual Cockpit Remote Hands-On Solution; SmartSimulator Intelligent Simulation Cloud; and Cinematic Anatomy Holographic Movie Anatomy Technology.

Pfizer Launches "Innovative Payment Roundtable," Inviting Representatives from Healthcare, Medical Insurance, Pharmaceuticals, and Commercial Insurance to Gather Online, Focusing on the Challenges of Accessibility and Affordability of Urgently Needed Cancer Drugs in Clinical Practice. During this meeting, the "Lorlatinib Innovative Payment Project" was officially launched. This project focuses on the urgent clinical needs of innovative drugs for ALK-positive advanced non-small cell lung cancer patients, integrating the "one-stop" medical treatment model and the innovative payment model of the pioneer zone to accelerate the availability of anti-cancer innovative drugs in the Lecheng pioneer zone for patients.

Fresenius Medical Care, with its famous "The Kidney Kid," partners with multiple hospitals to launch the large-scale World Kidney Day public welfare campaign "Walk with Kids, Brighten Lives." This public welfare event involves six hospitals across China, with approximately 300 child patients, parents, and healthcare workers from nephrology and pediatrics departments engaging in face-to-face exchanges to collectively promote kidney-related knowledge.

Product News

Biopharmaceuticals

| R&D/Clinical

AstraZeneca's AZD8205 Submits for Clinical Trial in China; This Product is an Antibody-Drug Conjugate (ADC) Targeting B7-H4, Making it the Second ADC Drug Targeting this Site to be Submitted in China After Hansoh Pharma. The cell surface glycoprotein B7-H4 is overexpressed in a range of solid tumors, including breast cancer, ovarian serous carcinoma, endometrial cancer, and cholangiocarcinoma, but has limited expression in normal tissues, making it an attractive target for ADCs.

Transcenta and Bristol Myers Squibb Collaborate on Global Clinical Trial of TST001 in Combination with Opdivo for Patients with Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Cancer. Transcenta will act as the sponsor of the clinical study, while Bristol Myers Squibb will provide Opdivo to Transcenta for conducting clinical research related to the combination therapy with TST001.

Uniray Pharmaceuticals has signed an exclusive licensing and supply agreement with Bavarian Nordic, an integrated vaccines company based in Copenhagen. The agreement covers the development and commercialization of MVA-BN RSV in mainland China, Hong Kong, Macao, Taiwan, South Korea, and certain Southeast Asian countries. The agreement includes clinical development, which involves supporting the Phase III registration trial for MVA-BN RSV in China. This trial will be conducted separately from another Phase III trial that Bavarian Nordic plans to initiate in the first half of 2022 to support a U.S. Biologics License Application.

China's National Medical Products Administration Center for Drug Evaluation (CDE) official website announced that the obicetrapib tablets submitted by New Amsterdam Pharma have received clinical trial implied permission. It is proposed to be used as an adjunctive treatment to diet and maximum tolerated dose of lipid-lowering therapy for adult patients with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C).

| Approval/Approved

Pfizer's COVID-19 Treatment Drug Included in Medical Insurance Payment Scope. The National Healthcare Security Administration issued the "Notice on Effectively Carrying Out the Current Epidemic Prevention and Control Medical Security Work." The notice mentioned timely adjustments to the scope of medical insurance payments for COVID-19 treatment drugs, stating that the newly added Nirmatrelvir Tablets/Ritonavir Tablets in the "Diagnosis and Treatment Protocol for COVID-19 (Trial Version 9)" should be procured by medical institutions at prices agreed upon by companies and relevant departments, with the medical insurance department responsible for handling payments accordingly.

Novartis (China) announced that a new generation of innovative drug for the treatment of fundus diseases – smaller molecule Brolucizumab (RTH258) – has been approved for priority clinical urgent use in medical institutions within the Greater Bay Area. The first injection in the Greater Bay Area was completed on March 27, 2022, at Zhuhai C-MER Dennis Lam Eye Hospital. Brolucizumab is currently the only fundus disease drug approved in the Greater Bay Area that can be injected once every three months after the loading phase. Compared with existing treatments, it features a smaller molecular weight, faster resolution of fluid, and longer treatment intervals.

Novartis' Multiple Sclerosis Treatment Drug Kesimpta (Ofatumumab) Issued the First Prescription in China. Currently, the world's only fully human CD20 monoclonal antibody tailored for multiple sclerosis patients, ofatumumab (trade name: Kesimpta), has issued its first prescription in China, marking the official introduction of a groundbreaking innovative drug in the global multiple sclerosis treatment field into China. Ofatumumab was approved by the National Medical Products Administration in December 2021 for the treatment of adult relapsing multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting multiple sclerosis, and active secondary progressive multiple sclerosis.

CDE has granted priority review and approval status to the SGLT2 inhibitor Jardiance (generic name: empagliflozin tablets) from the Boehringer Ingelheim/Eli Lilly diabetes alliance for the proposed new indication of treating adult patients with heart failure with preserved ejection fraction. Previously, empagliflozin had been approved in China for the treatment of type 2 diabetes.

Takeda's Innovative Lung Cancer Drug, Alunbrig (Brigatinib Tablets), Approved by the National Medical Products Administration. Takeda China announced that its innovative lung cancer drug, Alunbrig (Brigatinib Tablets/Brigatinib), has officially received approval from the National Medical Products Administration (NMPA) for monotherapy in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Alunbrig (Brigatinib Tablets) is a novel ALK tyrosine kinase inhibitor. Its efficacy in extending patient survival, controlling brain metastases, and improving quality of life has been clinically validated. It is listed as a first-line preferred treatment in the NCCN Clinical Practice Guidelines in Oncology and included in the CSCO Guidelines for the Diagnosis and Treatment of Non-Small Cell Lung Cancer.