Dual-Channel Pharmacy Selection Criteria Announced; Lisheng Pharmaceutical VP Resigns

[November 24, 2021 / Pharmaceutical News Overview]Takeda's antiviral therapy approved for marketing in the U.S.; Regeneron invests over $900 million in DNA vaccine development; Positive results from clinical trials of bispecific antibody for refractory HER2-positive breast cancer...Daily Fresh Pharmaceutical News and Medical Updates, Speed Reading to Keep You Informed!

Part 1 Policy Brief

Dual-Channel Pharmacy Selection Criteria Released! To Be Implemented Next Month

On the 23rd, the Jiangxi Provincial Medical Insurance Bureau issued the "Interim Measures for the Management of Dual-Channel Negotiated Drugs in Jiangxi Province," specifying that it will be implemented starting from December 1, 2021. The Measures indicate that dual-channel drugs will be managed under a "three-designated management system" involving designated medical institutions, designated responsible physicians, and designated retail pharmacies, with mutual recognition across the province. (Jiangxi Provincial Medical Insurance Bureau)

NMPA Proposes to Revise the "List of Medical Devices Prohibited from Contract Manufacturing" with More Detailed Entries Related to Medical Aesthetics

Recently, the NMPA released the "Catalogue of Medical Devices Prohibited from Contract Manufacturing (Draft for Comments)." Compared to the current version issued in 2014, the main adjustments related to medical aesthetics are: the original entry "plastic surgery implants" has been detailed into four entries: plastic surgery filling materials, injectable fillers for plastic surgery, breast implants, and tissue engineering scaffold materials. (NMPA)

Part 2: Industry Economic Observation

Over $900 Million to Develop Innovative DNA Vaccine: Regeneron Partners Up

On the 23rd, Nykode Therapeutics announced that it had reached a licensing and collaboration agreement with Regeneron to discover, develop, and commercialize five novel DNA vaccines for cancer treatment and infectious disease prevention. Under the terms of the agreement, Nykode will receive a $30 million upfront payment and $20 million in equity investment. Additionally, Nykode is eligible to receive over $875 million in milestone payments, as well as tiered royalties on future potential commercial product sales. (WuXi AppTec)

Pfizer's COVID-19 Oral Drug Paxlovid Costs $529 per Course

Recently, Pfizer announced that the U.S. government has ordered 10 million courses of the oral antiviral drug Paxlovid for $5.29 billion, provided the drug receives regulatory approval. This means the price of a course of Paxlovid is $529. (Corporate Announcement)

Cheng Hongjia, Vice General Manager of Lisheng Pharmaceutical, Resigns

On the 24th, Lisheng Pharmaceutical announced that Cheng Hongjia would no longer serve as the company's vice general manager due to a work-related change. His position change report took effect from the date it was delivered to the company's board of directors. (Corporate Announcement)

Part 3 Pharmaceutical News and Medical Information

Roche Announces Latest Results for Multiple Bispecific Antibodies and ADC Therapies

On the 24th, Roche announced that it would present clinical results of a series of innovative therapies for different blood diseases at this year's American Society of Hematology (ASH) Annual Meeting. The results described in the ASH abstract showed that mosunetuzumab monotherapy demonstrated anti-cancer activity in the majority of patients. The objective response rate (ORR) reached 78.9%, and the complete response rate (CR) reached 57.8%. The median progression-free survival (PFS) was 17.9 months. Mosunetuzumab also exhibited consistent anti-cancer activity across pre-specified patient subgroups. Clinical trial data described in the ASH abstract indicated that glofitamab as a monotherapy achieved an ORR of 81% and a complete metabolic response (CMR) rate of 70% in early clinical trials for patients with relapsed/refractory follicular lymphoma. When combined with the already approved anti-CD20 antibody, the ORR was 100%, and the CMR was 73.7%. (WuXi AppTec)

Bispecific Antibody Shows Positive Results in Clinical Trial for Refractory HER2-Positive Breast Cancer

Recently, Zymeworks announced that its HER2-targeting bispecific antibody Zanidatamab, when used in combination with chemotherapy, demonstrated encouraging and durable anti-cancer activity in a Phase 1 clinical trial for heavily pretreated, refractory HER2-positive breast cancer patients. Clinical trial results of Zanidatamab showed that among 16 evaluable patients, the combination therapy achieved an objective response rate of 37.5% and a disease control rate of 81.3%. In terms of safety, treatment-related adverse events were consistent with the previously reported safety profiles of Zanidatamab and chemotherapy, with most adverse events being Grade 1 or 2. (BioExplorer)

Targeting Bladder Cancer! Linton Medical's Catumaxomab Bispecific Antibody Phase 1/2 Trial Completes First Patient Dosing

Recently, Linton Pharmaceuticals announced that the first patient has been dosed in a Phase 1/2 clinical trial of its investigational antibody drug Catumaxomab for non-muscle invasive bladder cancer. This is a multicenter clinical study designed to evaluate the safety and efficacy of Catumaxomab in NMIBC patients who have failed or are intolerant to BCG treatment. (Sina Medicine News)

Innovative mTOR Inhibitor Approved by FDA for Market Launch; Eddingpharm Jingang Holds Greater China Rights

On the 23rd, Aadi Bioscience announced that the FDA had approved the innovative mTOR inhibitor Fyarro for marketing, indicated for intravenous treatment of adult patients with locally advanced unresectable/metastatic malignant perivascular epithelioid cell tumors. Fyarro is the first FDA-approved drug for treating adult advanced malignant PEComa. Notably, in January this year, China's Yiteng Jingang company announced an exclusive licensing collaboration with Aadi, obtaining exclusive development and commercialization rights for the drug in Greater China. (WuXi AppTec)

Hefei Lifang Pharmaceutical Nifedipine Controlled-Release Tablets Enter Administrative Approval Stage

Recently, the nifedipine controlled-release tablets produced by Hefei Lifang Pharmaceutical with a generic type 4 application have entered the administrative approval stage. Nifedipine belongs to the dihydropyridine class of calcium antagonists, which can selectively inhibit the transmembrane transport of calcium ions into cardiac and smooth muscle cells, as well as inhibit the release of calcium ions from intracellular stores without changing the plasma calcium ion concentration. It is clinically used for the treatment of hypertension and angina pectoris. (MENET)

Sanyou Medical's Ultrasonic Soft Tissue Cutting and Hemostasis Device Obtains Medical Device Registration Certificate

On the 24th, Sanyou Medical announced that its holding subsidiary, Shuimu Tianpeng, had recently received the "People's Republic of China Medical Device Registration Certificate" for the "Ultrasonic Soft Tissue Cutting and Hemostasis Device" issued by NMPA. It will be used in medical institutions for cutting and hemostasis of soft tissues during surgery and can be used to close blood vessels with a diameter of no more than 3mm. (Corporate Announcement)

Xinhua Medical's 2 Products Obtain Class II Medical Device Registration Certificates

On the 24th, XinHua Medical announced that the company had recently received the "People's Republic of China Medical Device Registration Certificate" issued by the Shandong Provincial Drug Administration, involving products such as multi-chamber fully automatic cleaning disinfectors and serum amyloid A test kits. (Corporate Announcement)

NICE Recommends Roche's Risdiplam for the Treatment of Spinal Muscular Atrophy

Recently, the UK NICE has released a draft guideline recommending Roche's risdiplam as part of a managed access agreement for the treatment of the rare genetic disorder spinal muscular atrophy. (Sina Medicine News)

Biogen's Next-Generation Fumarate Product Vumerity Approved by UK MHRA

Recently, the UK Medicines and Healthcare products Regulatory Agency approved Biogen's Vumerity for the treatment of relapsing-remitting multiple sclerosis. This drug is a next-generation fumarate oral therapy. (Sina Medicine News)

BeiGene's BRUKINSA® Approved in the EU for the Treatment of Adult Waldenström's Macroglobulinemia

On the 24th, BeiGene announced that the European Commission has approved Brukinsa® for the treatment of adult patients with Waldenström's macroglobulinemia (WM) who have received at least one prior therapy or as a first-line treatment for WM patients unsuitable for chemo-immunotherapy. (Sina Medicine News)

Sanofi Collaborates with Baidu to Develop mRNA Vaccines, Partners with Owkin to Advance AI Drug Discovery

Recently, Sanofi has reached two collaborations: one with Owkin to develop new therapies for four specific types of cancer; the other to acquire Baidu's mRNA sequence design algorithm for the design of vaccines and therapeutic products. (PharmaCube)

Good News for Diabetes Patients! FDA Grants GWave Breakthrough Device Designation

On the 23rd, HAGAR announced that the FDA granted GWave Breakthrough Device Designation. GWave is the world's first non-invasive continuous blood glucose monitoring technology using radiofrequency waves to measure glucose levels in the blood. (Sina Medicine News)

Takeda's Antiviral Therapy Livtencity Receives FDA Approval for Market Launch

On the 24th, the FDA announced the approval of Takeda's antiviral therapy Livtencity for marketing, used to treat refractory cytomegalovirus infections in adult or pediatric patients aged 12 years and older who have undergone hematopoietic stem cell transplantation or solid organ transplantation. This is the first approved therapy for this patient population. (WuXi AppTec)

Fosun Pharma's Controlling Subsidiary Withdraws Sodium Cromoglicate Granules Drug Registration Application

On the 24th, Fosun Pharma announced that its holding subsidiary Aohong Pharmaceutical had voluntarily applied to the NMPA to withdraw the marketing authorization application for Sodium Cromoglicate Granules, and recently received the NMPA's notice agreeing to the withdrawal. The new drug is mainly intended for the treatment of atopic dermatitis caused by food allergies. (Corporate Announcement)

First-Line Cervical Cancer: Hengrui's PD-L1/TGFβ Dual-Function Fusion Protein Initiates Phase III Clinical Trial

On the 23rd, Insight database showed that Hengrui Medicine launched a Phase III clinical trial to explore the first-line treatment of cervical cancer with PD-L1/TGFβ bifunctional fusion protein SHR-1701 in combination with chemotherapy and bevacizumab biosimilar BP102. (Insight Database)

CDE Approves KN046 Combined with Chemotherapy for Phase III Clinical Trial in Advanced Pancreatic Cancer by Alphamab Oncology

On the 24th, the CDE approved the Phase III registrational clinical trial application for KN046, a PD-L1/CTLA-4 bispecific antibody developed by Alphamab Oncology, in combination with albumin-bound paclitaxel and gemcitabine for the treatment of advanced pancreatic cancer. (PR Newswire)

IL-2 Immunostimulatory Therapy Submitted for Clinical Trial in China

On the 24th, the CDE announced that Nektar Therapeutics and Bristol-Myers Squibb had submitted a clinical trial application for NKTR-214. Public information shows that this is an agonist targeting the IL-2 signaling pathway, which has previously been granted Breakthrough Therapy Designation by the FDA. (CDE)

Novo Nordisk's Diabetes Combination Weekly Formulation IcoSema Injection Approved for Clinical Use in China

CDE Latest Announcement: Novo Nordisk's Application for the New Drug IcoSema Injection Has Received Clinical Trial Implied Permission, Intended for Development to Treat Diabetes. According to Public Information, IcoSema is a Combination of Long-Acting Insulin Icodec and Long-Acting GLP-1 Analog Semaglutide, Currently Undergoing Phase 3 Clinical Trials for Type 2 Diabetes Worldwide. (CDE)

Zai Lab's Multi-Target Inhibitor Approved for Clinical Trials for the First Time

On the 23rd, the CDE announced that the TPX-0022 capsule introduced by Zai Lab has received two clinical tacit approvals for the proposed development to treat patients with locally advanced or metastatic non-small cell lung cancer, gastric cancer, or solid tumors with MET gene alterations. (CDE)