CDE Releases Second List of Clinically Urgent Overseas Drugs, Five Products Excluded

[May 29, 2019 / Overview of Pharmaceutical News]Allergan Officially Submits IND Application for Atogepant for Preventive Treatment of Migraine; Jiangsu Province Follows Suit or May Follow the “4+7” Volume-Based Procurement; Longjin Pharmaceutical’s Wholly-Owned Subsidiary Enters Generic Drug Market with Nearly RMB 50 Million Investment; $1 Billion! Eli Lilly Acquires Global Exclusive Rights to a Novel Non-Opioid Analgesic... Stay Tuned with Sudu She for Daily Fresh Pharmaceutical and Medical News!(Click the title to access the original text)

Part 1 Policy Brief

| Following Urban Medical Consortia, County-Level Medical Communities Have Also Arrived

On the 28th, the Department of Primary Health Care of the National Health Commission issued the "Notice on Promoting the Construction of Close-knit County-level Medical and Health Consortia," pointing out that by the end of 2020, a new type of county-level medical and health service system would be initially established in 500 counties, gradually forming a community of services, responsibilities, interests, and management. (Medical Geography)

| Anhui Province Releases Latest Standards for Medical Insurance Reimbursement

On the 28th, the General Office of the People's Government of Anhui Province issued the "Implementation Plan (Trial) for Unifying Basic Medical Insurance and Critical Illness Insurance Benefits for Urban and Rural Residents in Anhui Province." The Plan primarily integrates the current benefits of urban and rural resident medical insurance and the New Rural Cooperative Medical Scheme, without introducing new policy provisions. (Pharmaceutical Representative)

| Joint Proposal from 14 Provinces! Abandon Lowest-Price and Exclusive Bid Awards

Recently, a document titled “Proposal Report on Prudently Advancing the Pilot Work of the New Round of Centralized Drug Procurement” has been circulating in the industry. The document, jointly submitted by pharmaceutical associations from 14 provinces to the National Healthcare Security Administration (NHSA), recommends that the NHSA prudently advance the “4+7” centralized procurement program based on lessons learned. It advises closely monitoring existing issues, conducting multi-dimensional risk assessments, soliciting opinions from industry associations and enterprises, and promoting implementation in an orderly manner through phased, batched, and categorized approaches. (Saibailan Medical Devices)

| Jiangsu Province to Follow or Potentially Adopt the "4+7" Volume-Based Procurement Program

Recently, the Health Commission of Wuxi City, Jiangsu Province, issued the "Key Points for Municipal Health and Wellness Work in 2019," explicitly stating that it would align with the national drug volume-based procurement (VBP) "4+7" prices and facilitate the entry of price-reduced drugs into hospitals. This document confirms earlier industry rumors that the Jiangsu Provincial Healthcare Security Administration is conducting research on Wuxi City’s comprehensive adoption of the "4+7" price linkage mechanism. The market implementation is expected to launch in the second quarter. After a one-quarter trial period, other prefecture-level cities in Jiangsu Province are scheduled to fully adopt the "4+7" price linkage in the fourth quarter or the first quarter of the following year. (Sai Bailan)

Part 2 Industrial and Economic Observation

| Yixintang Plans to Raise RMB 1.6 Billion, Intends to Inject RMB 230 Million in Capital Increases into Four Subsidiaries |

On May 29, it was reported that Yixintang held the 14th meeting of its fourth board of directors yesterday, conducting on-site and remote voting on 11 proposals, including the "Proposal on the Issuance of Medium-Term Notes." Yixintang plans to inject RMB 230 million in capital into four wholly-owned subsidiaries and intends to publicly issue medium-term notes and short-term financing bills to raise RMB 1.6 billion. The funds will be primarily used to supplement the company's working capital, repay interest-bearing debts, and support other production and business activities compliant with national laws, regulations, and policy requirements. (Iyiou)

| Longjin Pharmaceutical's Wholly-Owned Subsidiary Enters Generic Drug Market with Nearly RMB 50 Million Investment

May 28 News: Recently, Yunnan Longjin Fantian Biotechnology Co., Ltd., a wholly-owned subsidiary of Longjin Pharmaceutical, signed the "Agreement on Joint Establishment of a Company" with its partners Wuxi Jinhuisheng Technology Co., Ltd. and Shanghai Rongyu Biopharmaceutical Technology Co., Ltd. The parties plan to establish a limited liability company in Suzhou, Jiangsu Province, to engage in the research and development of generic drugs. The registered capital of the joint venture will be RMB 97 million, with Longjin Fantian holding a 51% equity stake and contributing RMB 49.47 million. (Iyiou)

| GSK and Pfizer Establish Joint Venture

On May 24 (U.S. local time), the CCI announced its approval of the joint venture established by pharmaceutical company Pfizer and healthcare company GlaxoSmithKline (GSK). GSK CEO Emma Walmsley will serve as the CEO of the new joint venture until her departure. In December 2018, GSK stated that it had reached an agreement with Pfizer to merge their consumer health businesses and establish a new joint venture, in which GSK would hold a 68% controlling stake and Pfizer would hold a 32% stake. (Arterial Network)

| Zipline Completes $190 Million Series C Financing

Zipline, a medical drone manufacturer, recently completed a $190 million Series C financing round, pushing its post-money valuation above $1 billion. The company will use the funds to further expand its markets in Africa, South Asia, Southeast Asia, and the Americas. In these regions, Zipline’s medical drones can deliver medicines to remote areas with underdeveloped road and rail transport systems. (Arterial Network)

Part 3 Pharmaceutical and Medical News

| Another Breakthrough in Anti-Tumor Drugs: Sihuan Pharmaceutical’s Third-Generation EGFR Inhibitor XZP-5809 Approved for Clinical Trials

On the morning of May 29, Sihuan Pharmaceutical, a biopharmaceutical company listed on the Hong Kong Stock Exchange, announced that its independently developed Class 1 innovative drug, the third-generation EGFR inhibitor XZP-5809, had received approval for clinical trials from the National Medical Products Administration. (Sina Medical News)

| Allergan Officially Submits IND Application for Atogepant for the Preventive Treatment of Migraine

On May 29, the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) showed that Allergan had formally submitted an Investigational New Drug (IND) application for Atogepant, with the acceptance number JXHL1900114. Reportedly, this is the second oral CGRP receptor antagonist to file an IND application in China. (Sina Pharmaceutical News)

| CDE Announces the Second Batch of Overseas New Drugs Urgently Needed for Clinical Use, with Five Products Excluded |

On May 29, the Center for Drug Evaluation of the National Medical Products Administration issued a notice, officially releasing the second batch of the list of overseas new drugs in urgent clinical need, which includes 26 varieties with no objections, such as Biopten Granules. (Sina Pharmaceutical News)

| First Chemotherapy-Free Regimen for NHL! Revlimid Combined with Rituximab Approved by FDA

Celgene Announced on May 28 That the U.S. FDA Has Approved the Revlimid (Lenalidomide) and Rituximab Combination Therapy (R²) for Adult Patients with Previously Treated Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL). Additionally, Celgene Has Submitted a Supplemental Application to Japanese Regulatory Authorities for the R² Regimen in the Treatment of Relapsed/Refractory Indolent B-Cell Non-Hodgkin Lymphoma (NHL). (Sina Medical News)

| Hansoh Acquires China Development and Commercialization Rights for “Breakthrough Therapy” Inebilizumab for $220 Million

On May 28, Viela Bio/Hansoh Pharma announced the signing of a collaboration agreement for the development in China of the CD19 monoclonal antibody inebilizumab for the treatment of neuromyelitis optica spectrum disorders (NMOSD) and other autoimmune diseases, as well as hematologic malignancies. (PharmCube)

| BioMarin’s Phase III Study of Hemophilia A Gene Therapy Meets Expectations; Marketing Application to Be Filed |

BioMarin Announces on May 28 That Gene Therapy Valocogene Roxaparvovec (valrox) for Hemophilia A Met Pre-Specified Clinical Criteria for Regulatory Review in the US and EU. The company stated it will meet with the US FDA and the EU EMA to review Phase III study data and other elements of the submission dossier, and plans to announce the regulatory submission timeline in the third quarter of this year. (Sina Medical News)

| $1 Billion! Eli Lilly Acquires Global Exclusive Rights to a Novel Non-Opioid Analgesic

On May 28, Eli Lilly announced an in-licensing agreement, securing exclusive global rights to CNTX-0290, a pain therapy candidate from Centrexion Therapeutics. Under the terms of the agreement, Lilly will pay Centrexion an upfront payment of $47.5 million, along with up to $575 million in development and regulatory milestone payments. Upon successful commercialization of CNTX-0290, Centrexion will also be eligible for $375 million in sales milestone payments and tiered royalties ranging from low single digits to low double digits. (Sina Pharmaceutical News)

| A Well-Known Pharmaceutical Company in Jiangxi Summoned for Talks! Listed as a Key Regulatory Target

On the 28th, the Jiangxi Provincial Medical Products Administration released the “Announcement on Unannounced Inspections and Handling of Drug Distribution in Jiangxi Province.” The announcement stated that the Jiangxi Provincial MPA conducted an unannounced inspection of Jiangxi Jimin Kexin Pharmaceutical Trading Co., Ltd., identified violations of Good Supply Practice (GSP) regulations, and consequently held regulatory interviews, mandated rectification within a specified timeframe, and designated the company as a key supervisory target. (Medical Representative)

| Novartis’ Two Blockbuster Products Receive FDA Approval on the Same Day

On May 24, two blockbuster products from Novartis received FDA approval. One is Zolgensma, an innovative gene therapy for the treatment of spinal muscular atrophy in children under two years of age; the other is Piqray, a PI3K inhibitor, which is used in combination with fulvestrant for the treatment of patients with HR+/HER2- advanced or metastatic breast cancer harboring PIK3CA mutations. (CPhI Online)

| A Pharmaceutical Company Announces 37% Workforce Reduction and CEO Dismissal

Dynavax, a company developing hepatitis B vaccines and immunotherapeutic drugs, recently announced its withdrawal from the immuno-oncology pipeline, laying off 82 employees—37% of its current workforce—and dismissing its CEO. According to industry media FierceBiotech, these measures aim to create a leaner development model at the commercialization stage, allowing the company to better focus on sales of its star product, the hepatitis B vaccine HEPLISAV-B. (Saibailan)

| First Batch of Class III Medical AI Certificates Enters Approval Phase: Commercialization Door for Such Products Is About to Open

Recently, Ji Xin, CEO of SHANGGONG, a medical AI company, revealed that its AI-powered automated screening product for diabetic retinopathy has passed testing by the National Institutes for Food and Drug Control (NIFDC) and entered the clinical trial phase. This marks the official commencement of the approval process for Class III medical device certification, long anticipated by the industry. (Ba Dian Jian Wen)

| Researchers Discover a New Class of Anti-Cancer Drugs

Researchers at New York University developed and investigated the biological activities of five novel metal-organic hybrid knotted molecules, known as metal-organic trefoil knots (M-TKs). These molecules can effectively deliver metals to cancer cells, demonstrating potential as a new class of anticancer drugs. The study was published in Chemical Science. (Bioon)

| Scientists Discover New Gene That Regulates Muscle Cells

Scientists at York University in Canada have identified a unique pair of genes, Smad7 and β-catenin, that work synergistically in the body to regulate muscle cell differentiation, growth, and repair. These genes play a crucial role in the gene expression and differentiation of muscle cells, potentially leading to new therapeutic targets for preventing the spread of muscle cancers. (Bioon)

| Largest-Ever Sequencing Study Links Rare DNA Variants to Type 2 Diabetes

An international consortium of scientists analyzed protein-coding genes in nearly 46,000 individuals and discovered that rare DNA variants are associated with type 2 diabetes. This study is among the largest of its kind to date, incorporating data from individuals of European, African American, Hispanic/Latino, East Asian, and South Asian ancestry. (Bioon)