AstraZeneca Files Patent Infringement Lawsuits Against Aosaikang Pharmaceutical and Chongqing Huabang Pharmaceutical

[May 5, 2019 / Pharmaceutical News Overview]GlaxoSmithKline’s triple therapy for asthma meets primary endpoint in Phase III clinical trial; Aipu Regenerative Medicine secures tens of millions of RMB in Series A financing; AstraZeneca files patent lawsuits against Ask Pharm and Huabang Pharmaceutical; Buchang Pharmaceuticals’ chairman responds: daughter’s overseas study funds are unrelated to the company; prices of a batch of drugs that passed consistency evaluation announced, Shandong clarifies it will not reference “4+7” procurement prices... Daily Pharma & Medical News invites you to quick-read!(Click the title to access the original text)

Part 1 Policy Brief

| Prices of a Batch of Generic Drugs Passing Consistency Evaluation Announced; Shandong Clarifies It Will Not Reference “4+7” Prices

Recently, the Shandong Provincial Drug Centralized Procurement Network released the "Notice on the Publication of Drugs in Our Province That Have Passed the Quality and Efficacy Consistency Evaluation." The notice publicized the online procurement prices for a batch of drugs that have passed the consistency evaluation, among others. Shandong had previously stipulated that the winning bid prices for pilot drugs under the national centralized drug procurement pilot program in pilot cities would not be included in the price reference scope. (Sai Bailan)

Part 2 Listed Companies

| Gilead’s New Leadership Makes Early Moves: Talent Recruitment for Kite, Increased M&A Activity, and Organizational Restructuring

Gilead Sciences appointed Daniel O’Day as Chairman of the Board and Chief Executive Officer last year, with the appointment taking effect on March 1, 2019. Since assuming office, Mr. O’Day has been implementing strategic adjustments, including plans to appoint a CEO for the Kite division to oversee its key CAR-T therapy, Yescarta. Meanwhile, Kite will operate as an independent business unit. (Sina Medical News)

| Chairman of Buchang Pharmaceuticals Responds: Daughter’s Overseas Study Funds Unrelated to Company

On May 1, according to foreign media reports, Zhao Tao, Chairman of Buchang Pharmaceutical Group, paid as much as $6.5 million to forge sailing certificates for his daughter, Zhao Yusi, to gain admission to Stanford University. On the 3rd, Zhao Tao issued a statement on the company’s official website, stating that his daughter’s studies in the United States were a personal and family matter, that the source of funds was unrelated to Buchang Pharmaceutical, and that this would have no impact on the financial status of Buchang Pharmaceutical. (Yiku)

| AstraZeneca Files Patent Lawsuits Against Ask Pharmaceutical and Chongqing Huapont Pharmaceutical

According to China Intellectual Property Magazine, AstraZeneca filed two separate patent infringement lawsuits against generic drug manufacturers Aosaikang Pharmaceutical and Huabang Pharmaceutical on April 23 and April 24, respectively. The products involved are the antidiabetic drug saxagliptin (Onglyza) and the breast cancer treatment drug anastrozole (Arimidex). (GBI Health)

Part 3 Investment and Financing

| Alp Regenerative Medicine Secures Tens of Millions of RMB in Series A Funding to Boost Cardiac Regenerative Therapy

On the 5th, Nanjing Alpu Regenerative Medicine announced the completion of its Series A financing, amounting to tens of millions of RMB. The funds will be used to advance the clinical research of the company's heart failure project and to support the research and development of its other product lines. (Arterial Network)

| Vividion Therapeutics Completes Series B Financing to Develop Small-Molecule Targeted Drugs

Vividion Therapeutics Completes $82 Million Series B FinancingRecently, biotechnology company Vividion Therapeutics completed an $82 million Series B financing round. The proceeds from this round will be used to support the company’s research into small-molecule proteolysis-targeting chimeras (PROTACs) for the treatment of tumors, cancer, and inflammatory diseases. (Arterial Network)

| Atia Vision, the largest segment in ophthalmology, completes $20 million Series D financing

Recently, Atia Vision, a medical device company under the Silicon Valley healthcare innovation incubator Shifamed, announced the completion of a $20 million Series D preferred stock financing round. Reportedly, Atia Vision will use the proceeds from this round to advance the clinical development of a novel intraocular lens. (Arterial Network)

| Alentis, an Emerging Biotech Company Developing Antibody Drugs for Advanced Liver Disease, Completes $12.5 Million Series A Financing

Alentis Therapeutics Announces Completion of CHF 12.5 Million (EUR 11.1 Million; USD 12.5 Million) Series A FinancingAlentis Therapeutics recently announced the completion of its Series A financing round, raising CHF 12.5 million (EUR 11.1 million; USD 12.5 million). The company stated that the funds will be used to develop novel therapeutics for advanced liver diseases, addressing unmet medical needs such as liver fibrosis, cirrhosis, liver failure, and advanced hepatocellular carcinoma. (Chuangjian Hui)

| Symplr Acquires Healthcare Software Company IntelliSoft to Enhance SaaS Platform Credentialing Services

Symplr has recently completed its acquisition of IntelliSoft, without disclosing the transaction amount. This marks Symplr’s seventh acquisition in the past six years, backed by Clearlake Capital Group (and its subsidiary Clearlake) and SkyKnight Capital Group (and its subsidiary SkyKnight). (Arterial Network)

Part 4 Pharmaceutical News and Medical Updates

| New Indication on the Horizon! GlaxoSmithKline’s Triple Therapy for Asthma Meets Primary Endpoint in Phase III Clinical Trial

GlaxoSmithKline and Innoviva recently jointly announced the positive topline results from the pivotal Phase III CAPTAIN clinical trial (NCT02924688) evaluating Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, FF/UMEC/VI), a novel respiratory medication, for the treatment of asthma. (Sina Pharmaceutical News)

| AstraZeneca’s Triple-Combination Therapy for Type 2 Diabetes Receives FDA Approval

AstraZeneca announced on the 4th that the FDA has approved the marketing of Qternmet XR extended-release tablets, developed by the company, to improve glycemic control in adults with type 2 diabetes when used in conjunction with diet and exercise. Qternmet XR is an oral triple-combination therapy comprising dapagliflozin, saxagliptin, and metformin. (WuXi AppTec)

| Genentech’s Innovative ADC Approved for Early-Stage Breast Cancer, Validating a New Model of Clinical Development

On the 4th, Genentech announced that the FDA had approved an expanded indication for its antibody-drug conjugate Kadcyla as adjuvant therapy for patients with HER2-positive early-stage breast cancer who have residual invasive disease after receiving neoadjuvant therapy. This approval not only provides a new treatment option for patients with early-stage breast cancer but also validates a new model for conducting clinical trials in patients with high-risk early-stage breast cancer. (WuXi AppTec)

| Innovative Companion Diagnostic Test Receives FDA Breakthrough Device Designation

On the 4th, Caris Life Sciences announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Device Designation to its MI Transcriptome companion diagnostic test. This assay is designed to detect gene fusions in solid tumors, helping clinicians identify cancer patients who may benefit from specific targeted therapies. Caris plans to submit a Premarket Approval (PMA) application later this year. (WuXi AppTec)

| Marketing Application Submitted for Long-Acting Dual-Drug Regimen for HIV, Facilitating Long-Term Benefits for Patients

Recently, the long-acting dual-drug regimen for HIV treatment, “cabotegravir + rilpivirine,” submitted a marketing application to the FDA. This dual-drug combination is the world’s first long-acting HIV medication and can be used in patients with suppressed viral loads. The long-acting dual-drug regimen demonstrates effective viral control, excellent safety, and good tolerability, offering the potential to significantly improve adherence among people living with HIV over the long term. This regimen represents another breakthrough in HIV treatment. (CPhI Online)

| One licensed pharmacist can serve 40 pharmacies.

CITIC Securities’ Recent Survey Report on Dashenlin’s Prescription Sharing PlatformA recent survey report on Dashenlin’s prescription sharing platform, released by CITIC Securities, stated that to align with classified and tiered management requirements, Dashenlin has pioneered a pilot remote prescription review system in Guangzhou. The one-time investment for developing Dashenlin’s remote prescription review platform was approximately RMB 2 million. Based on actual operational assessments, it is estimated that one licensed pharmacist can oversee 30–40 stores. This indicates that, at a certain scale, a single licensed pharmacist may be able to serve up to 40 retail outlets. (Pharmacy Manager)

| Breaking Through the Bottleneck: Chinese Scientists Successfully Establish a Hepatitis B Virus Infection Model

In a collaborative study involving the research groups of Professor Deng Hongkui at Peking University, Professor Lu Shichun at the Chinese PLA General Hospital, and Professor Yuan Zhenghong at Fudan University, researchers demonstrated for the first time that small chemical molecules can modulate cell signaling pathways, thereby facilitating the long-term maintenance of functional hepatocytes in vitro. Furthermore, the study confirmed that these hepatocytes could support persistent long-term infection with hepatitis B virus (HBV) and hepatitis C virus (HCV) in vitro. This research provides a feasible approach for the large-scale production of functionally mature cells and their subsequent applications. (BioExplorer)

| The Lancet: Zero Risk of HIV Transmission Under Antiretroviral Therapy

Recently, a landmark research paper was published in The Lancet, a top-tier medical journal. Scientists discovered that under existing antiretroviral therapy (ART), the risk of HIV transmission remains 0% even with unprotected sexual intercourse. This study also places humanity at a historical juncture in the effort to eradicate AIDS. (Academic Horizon)

| Scientists Identify Key Link Between Brain and Gut Stem Cells

Scientists from Rutgers University have identified a novel factor through research that is crucial for maintaining the function of stem cells in the gut and brain. The absence of this factor can induce anxiety, cognitive impairments, and even gastrointestinal disorders. (Bioon)

| New Oral Cancer Biomarkers Discovered

A research report published in the international journal Epigenomics reveals that scientists from the University of Otago and other institutions have found that epigenetic markers in oral cancer tissues may differ from those in adjacent non-cancerous oral tissues, and these biomarkers may be closely associated with the survival rates of patients with oral cancer. (Bioon)

| Molecular Mechanisms of Resistance to BRAF Inhibitor Therapy in Melanoma Discovered

Recently, a research report published in the journal Cancer Research elucidated the molecular mechanisms by which melanoma develops resistance to a common drug frequently used to target the BRAF protein and its signaling pathway. (Bioon)

Part 5 Internet+

| Pharma Giant AstraZeneca Partners with UK AI Firm to Accelerate Development of Two New Drugs

AstraZeneca Announces Long-Term Collaboration with UK AI Company BenevolentAI to Accelerate Discovery of New Drugs for Chronic Kidney Disease and Idiopathic Pulmonary Fibrosis Using AI and Machine Learning Technologies (Leifeng.com)

| FDA Grants Breakthrough Device Designation to First AI Product for Kidney Disease Diagnosis

UK-based AI diagnostics company for kidney disease, RenalityixAI, announced that its diagnostic product, KidneyIntelX™, has been granted Breakthrough Device designation by the FDA, making it the first AI-driven kidney disease diagnostic system on the market to receive this distinction. The most recent company with a similar achievement is digital pathology firm Paige.AI, which received the designation in early April. (Leiphone)