China's 10th Domestic PD-1 Inhibitor Nears Market Approval; Golden Throat Announces Delisting

【November 1, 2021 / Medical News Digest】Zhenbaodao Plans to Invest 1.7 Billion RMB in Hangzhou Biologics Project; Golden Throat Set for Imminent Delisting; Allist’s Third-Generation EGFR-TKI Phase III Trial Meets Primary Endpoint……Daily Latest Pharma & Medical News: Quick Briefings for Your Attention!

Part 1 Policy Brief

Directors of Tianshui Health Commission and CDC in Gansu Removed from Office

On the 1st, the website of the Organization Department of the Tianshui Municipal Party Committee announced that, following deliberations by the Municipal Party Committee Standing Committee, it was decided to relieve: Comrade Chen Kexiao of his positions as Secretary of the Party Leadership Group and Director of the Tianshui Municipal Health Commission, and Secretary of the Health Work Committee of the CPC Tianshui Municipal Committee (concurrently); and Comrade Wu Yizhong of his position as Director of the Tianshui Municipal Center for Disease Control and Prevention. (Tianshui Municipal Party Committee Organization Department website, Gansu)

Part 2: Industry & Economic Review

Zhenbaodao: Plans to Invest 1.7 Billion RMB in Hangzhou Biopharmaceutical Project for Anti-Tumor ADC Drug R&D

On the 1st, Zhenbaodao announced that it plans to establish a wholly-owned subsidiary in Hangzhou Qiantang New Area to invest in and construct the company's Hangzhou biologics project, focusing on the research and development of anti-tumor ADC drugs, while simultaneously establishing other subsidiaries and developing other business operations. The project's planned total investment is approximately RMB 1.7 billion, of which about RMB 100 million will be allocated to fixed assets, and approximately RMB 1.6 billion will be dedicated to R&D over the next six years. (Company Announcement)

Golden Throat to Be Delisted

Recently, Golden Throat announced that the offeror and the company will privatize the company by way of a scheme of arrangement, with shares to be cancelled at HK$2.80 per scheme share. The listing status of the shares on the Stock Exchange is expected to be withdrawn at 9:00 a.m. on December 15, 2021. (Corporate Announcement)

MicroPort Medical Plans to Acquire Argus Medical for a Transaction Consideration of RMB 372 Million

Recently, MicroPort Medical announced that it will acquire a 38.33% equity stake in Argus for a transaction consideration of RMB 372 million. Upon completion of this capital increase, MicroPort Medical will hold a 51% stake in Argus, thereby obtaining control of the company. Additionally, should Argus successfully achieve the corresponding milestones in R&D progress and production enhancement, the existing shareholders of Argus may, between December 31, 2022, and June 30, 2024, require MicroPort Medical to further acquire a 31.55% equity interest in Argus for RMB 268 million. (Corporate Announcement)

Part 3 Medical & Pharmaceutical News

First-Line Treatment for NSCLC! Allist's Third-Generation EGFR-TKI Phase 3 Clinical Trial Meets Primary Endpoint

On the 1st, Allist Pharma announced that its Phase 3, multicenter, randomized, controlled, double-blind clinical trial evaluating Ivesa (furmonertinib), a third-generation EGFR-TKI, as first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-sensitizing mutations has met its primary endpoint of progression-free survival (PFS): compared with the control group receiving a first-generation EGFR-TKI, the furmonertinib treatment group demonstrated a statistically significant and clinically meaningful progression-free survival benefit. (Medical Observer)

AbbVie Announces Phase 3 Trial Data for Vraylar in Depression

Recently, clinical trial data for AbbVie’s antipsychotic drug Vraylar were released, failing to yield satisfactory results. In Study 3111-301-001, patients receiving 1.5 mg/day achieved a statistically significant improvement in MADRS total scores at Week 6 compared to placebo. Patients receiving 3 mg/day showed improvement in MADRS total scores at Week 6, but the results did not reach statistical significance compared to the control group. In Study 3111-302-001, patients treated with Vraylar demonstrated numerical improvements in depressive symptoms as measured by the MADRS total score from baseline to Week 6 compared to placebo; however, neither the 1.5 mg nor the 3 mg dose met the study’s primary endpoint. (Sina Medical News)

Treating Alzheimer's Disease: Stem Cell Therapy Shows Promising Potential

Recently, GABAeron announced positive preclinical study data for an induced pluripotent stem cell (iPSC)-based cell therapy for Alzheimer’s disease. Previous studies have shown that individuals carrying the APOE4 gene have a higher risk of developing Alzheimer’s disease and an earlier age of onset, with approximately 60–75% of Alzheimer’s patients expressing the APOE4 protein in their brains. These data demonstrate the potential of transplanting human iPSC-derived interneuron progenitor cells for the treatment of Alzheimer’s disease, as well as other neurological disorders characterized by interneuron deficits or loss. (WuXi AppTec)

Bioprojet's Ozawade Approved for Marketing in the European Union

Recently, the EMA approved Bioprojet's Ozawade for marketing authorization for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea in adult patients. (Bioon)

Sanofi/Regeneron's Libtayo for Advanced BCC Approved by Health Canada

Recently, Sanofi announced that Libtayo, an anti-PD-1 therapy co-developed with Regeneron, has been approved by Health Canada as a monotherapy for the treatment of adult patients with locally advanced or metastatic basal cell carcinoma who have experienced disease progression on, or are intolerant to, a hedgehog pathway inhibitor. (Bioon)

Xinshidai Pharmaceutical's NDA for Anti-PD-1 Monoclonal Antibology Accepted by CDE

On the 1st, the latest CDE announcement indicated that Xinshidai Pharmaceutical's Class I biological innovative drug, "Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection," has had its new drug application (NDA) accepted, for the treatment of relapsed or refractory diffuse large B-cell lymphoma in combination with Recombinant Anti-CD20 Chimeric Monoclonal Antibody Injection. (CDE)

Yuandong Biopharma Obtains Drug Registration Certificate for Repaglinide and Metformin Hydrochloride Tablets

On the 1st, Yuandong Biopharma announced that it recently received the 《Drug Registration Certificate》 approved and issued by the NMPA for Repaglinide and Metformin Hydrochloride Tablets. As an adjunct to diet and exercise, the drug is indicated to improve glycemic control in adults with type 2 diabetes mellitus. It is indicated for patients who have previously been treated with a combination of a glinide and metformin hydrochloride, or for patients whose glycemic control remains inadequate on monotherapy with either a glinide or metformin hydrochloride. （Company Announcement）

China Resources Double-Crane Pharmaceutical's Wholly-Owned Subsidiary Obtains "Drug Registration Certificate" for Two Drugs

On the 1st, China Resources Double-Crane Pharmaceutical announced that its wholly-owned subsidiary, China Resources Saike, recently received the 《Drug Registration Certificate》 from the NMPA for Amlodipine and Atorvastatin Calcium Tablets and Sildenafil Citrate Tablets, granting production approval for both drugs. Amlodipine and Atorvastatin Calcium Tablets are indicated for patients requiring combination therapy with amlodipine and atorvastatin. Sildenafil Citrate Tablets are indicated for the treatment of erectile dysfunction. (Company Announcement)

Yongtai Technology's Subsidiary's Domperidone Tablets Pass Generic Drug Consistency Evaluation

On the 1st, Yongtai Technology announced that its subsidiary, Foshan Shouxin Pharmaceutical, recently received the 《Notice of Approval for Drug Supplementary Application》 for the chemical drug domperidone tablets, approved and issued by the NMPA. The product has passed the consistency evaluation for generic drugs. Domperidone tablets are a gastrointestinal prokinetic agent. (Company Announcement)

Novartis' First-in-Class Complement Factor B Inhibitor Iptacopan Granted UK Innovation Passport Designation

Recently, Novartis announced that the MHRA, NICE, and the Scottish Medicines Consortium have granted an innovative passport qualification to the oral therapy iptacopan for the treatment of C3 glomerulopathy. Iptacopan is a first-in-class, potent, selective, small-molecule, reversible factor B inhibitor; factor B is a key serine protease in the alternative pathway of the complement system. (Bioon)

Joincare Mometasone Furoate Nasal Spray Enters Administrative Approval Phase

Recently, the official website of the NMPA indicated that Joincare's Mometasone Furoate Nasal Spray, submitted for marketing approval as a Class 4 generic drug, has entered the administrative approval stage, aiming to become the second domestic manufacturer. Mometasone Furoate Nasal Spray is a topical corticosteroid and a first-line treatment for rhinitis, particularly allergic rhinitis. It is indicated for the prevention and treatment of seasonal or perennial rhinitis in adults, adolescents, and children aged 3 to 11 years. (NMPA)

Kanghong Pharmaceutical's Vortioxetine Hydrobromide Tablets Enter Administrative Approval Stage

Recently, Kanghong Pharmaceutical’s application for vortioxetine hydrobromide tablets, submitted as a Class 4 generic, has entered the administrative approval stage, with the company aiming to become the third domestic manufacturer. Vortioxetine is a novel antidepressant developed by Denmark’s Lundbeck, featuring a multi-target mechanism of action. It simultaneously exerts serotonin transporter inhibition, serotonin receptor agonism, and 5-HT3 receptor antagonism. (NMPA)

Antengene's PD-L1/4-1BB Bispecific Antibody Receives Clinical Trial Approval in the US

On the 1st, Antengene announced that the FDA has approved its Investigational New Drug (IND) application for ATG-101, initiating this Phase I clinical study. ATG-101 is a bispecific monoclonal antibody under development by Antengene for the treatment of metastatic or advanced solid tumors and B-cell non-Hodgkin lymphoma. (PRNewswire)

Ganlai Pharmaceuticals' ASC43F for the Treatment of Nonalcoholic Steatohepatitis Receives US Clinical Trial Approval

On the 1st, Genla Pharma, a wholly-owned subsidiary of Ascletis Pharma, announced that its investigational pipeline candidate ASC43F has received FDA approval to initiate clinical trials and launched its global development program. ASC43F is a first-in-class, fixed-dose combination formulation targeting both the thyroid hormone receptor beta (THR-β) and farnesoid X receptor (FXR) for the treatment of nonalcoholic steatohepatitis (NASH). (PR Newswire)

Preventive Cancer Vaccines Enter Clinical Trials

Recently, the Cleveland Clinic announced the initiation of a novel Phase 1 clinical trial to evaluate the efficacy of a preventive cancer vaccine in preventing cancer recurrence in patients with early-stage triple-negative breast cancer. Preclinical studies have demonstrated that activating an immune response against alpha-lactalbumin can safely and effectively prevent breast cancer in mouse models. Furthermore, this study found that a single dose of the vaccine not only prevents the development of breast cancer in mouse models but also inhibits the growth of existing breast tumors. (WuXi AppTec)

BeiGene Initiates Phase III Clinical Trial of HER2 Bispecific Antibody in China

Recently, the China Drug Clinical Trial Registration and Information Disclosure Platform shows that BeiGene has initiated a Phase 3 study in China evaluating zanidatamab as a first-line treatment for advanced HER2-positive gastroesophageal adenocarcinoma. Zanidatamab is a bispecific antibody capable of simultaneously binding to two non-overlapping HER2 epitopes, a mechanism known as biparatopic binding. (China Drug Clinical Trial Registration and Information Disclosure Platform)