BGI Group Addresses Layoff Reports; Hengrui's Novel Antidepressant Receives IND Approval

[May 14, 2019 / Pharmaceutical News Overview]Celgene’s New Anti-Cancer Drug Receives FDA Breakthrough Therapy Designation; Hengrui’s Blockbuster Antidepressant Approved for Clinical Trials; Buchang Pharmaceuticals’ Annual Report Subject to Regulatory Inquiry; BGI Group Responds to Layoff Controversy; Fudan-Zhangjiang’s STAR Market Application Accepted; National Healthcare Security Administration: Reimbursement Rate for Critical Illness Insurance Increased from 50% to 60%... Daily Pharma and Medical News Briefing – Join Us for a Quick Read!(Click the title to access the original text)

Part 1 Policy Brief

|National Healthcare Security Administration: The reimbursement rate for critical illness insurance has been increased from 50% to 60%

Recently, the National Healthcare Security Administration, in conjunction with the Ministry of Finance, issued the “Notice on Doing a Good Job in Basic Medical Security for Urban and Rural Residents in 2019” (No. 30 [2019] of the National Healthcare Security Administration). The document pointed out that, regarding reimbursement for critical illness insurance, first, the deductible threshold should be lowered and unified, in principle determined at 50% of the per capita disposable income of residents from the previous year; if it is already below this proportion, no adjustment is required. Second, the reimbursement rate should be increased from 50% to 60%. (Sina Pharmaceutical News)

|Five Ministries Issue Document Encouraging Doctors to Open Clinics; Pilot Programs to Be Launched in 10 Cities|

On the 13th, the National Health Commission, the National Development and Reform Commission, the Ministry of Finance, the Ministry of Human Resources and Social Security, and the National Healthcare Security Administration jointly formulated the "Guiding Opinions on Launching Pilot Programs to Promote the Development of Clinics," encouraging physicians who have practiced in medical institutions for at least five years and hold intermediate or senior professional titles to establish specialized clinics on a full-time or part-time basis. Furthermore, from 2019 to 2020, pilot programs to promote clinic development will be launched in ten cities, including Beijing, Shanghai, and Shenyang. (Sina Pharmaceutical News)

|Beijing Municipal Medical Administration Bureau Exits the Historical Stage! Municipal Hospital Management Center Established

On the 13th, the Beijing Municipal Hospital Administration announced that, effective immediately, it has been restructured into the Beijing Hospital Management Center and has commenced operations. Pan Suyan has been appointed as Secretary of the Party Committee and Director; Bian Baosheng, Lü Yiping, and Liu Jianmin have been appointed as Standing Members of the Party Committee and Deputy Directors, at the deputy bureau-director level; Xu Changshun has been appointed as Deputy Inspector. (Health界)

| Ministry of Education Announces: Recruitment of 6,700 Tuition-Free Medical Students

Recently, the official website of the Ministry of Education issued the "Notice on Doing a Good Job in the Enrollment and Training of Tuition-Free Undergraduate Medical Students with Targeted Employment Contracts for Rural Areas in Central and Western Regions Supported by the Central Finance in 2019," announcing the enrollment and training plan for tuition-free undergraduate medical students with targeted employment contracts for rural areas in central and western regions in 2019, providing 6,700 tuition-free medical study quotas for central and western regions! (Primary Care Physicians Community)

Part 2 Listed Companies

|Fudan-Zhangjiang's STAR Market Listing Application Accepted; Plans to Raise RMB 650 Million

On the 13th, the official website of the STAR Market of the Shanghai Stock Exchange announced a new list of companies accepted for listing, with Fudan-Zhangjiang finally making its “belated appearance.” To date, 109 companies have obtained the “admission ticket” to the STAR Market. Among them, 86 have received inquiry letters, and one has had its review suspended. (PharmaCube)

| Buchang Pharmaceutical Faces Inquiry: Required to Disclose Details of RMB 8 Billion in Sales Expenses and Academic Promotion Activities |

Recently, Buchang Pharma disclosed in an announcement that the company had received a "Post-Review Inquiry Letter regarding Shandong Buchang Pharmaceutical Co., Ltd.'s 2018 Annual Report" from the Shanghai Stock Exchange (SSE). The SSE requested Buchang Pharma to provide further supplementary disclosures on issues such as sales models and revenue recognition, selling expenses, gross profit margins by business segment, R&D expenditures, and monetary funds, taking into account industry conditions and the company's operational performance. (Medical Representative)

|BGI Group Responds to Layoff Controversy as Subsidiary BGI Genomics Sees Continued Decline in Performance

On the 13th, media reports indicated that BGI Holdings, the controlling shareholder of BGI Genomics, a leader in gene sequencing, is undergoing “downsizing,” including layoffs and asset divestitures. On the same day, BGI Group responded publicly, stating that since the beginning of this year, its management team has formulated a business strategy of “strategic focus,” placing greater emphasis on supporting its two core business segments: BGI Genomics (the listed company) and MGI Tech. (The Paper)

Part 3 Investment and Financing

| Blackstone Acquires Nearly Half Stake in South Korean Drug Distributor for $945 Million

Blackstone Group, headquartered in the United States, recently announced that it has agreed to acquire Geo-Young, a South Korean wholesale pharmaceutical distributor, and has reached an agreement with the company’s founders. Blackstone’s private equity fund has agreed to purchase a 46% stake in Geo-Young from another private equity firm, Anchor Equity Partners, for 1.1 trillion won ($945.2 million). (Arterial Network)

| ElevateBio Completes $150 Million Series A Financing

On the 13th, biotechnology company ElevateBio completed a $150 million Series A financing round. Headquartered in Cambridge, Massachusetts, USA, ElevateBio focuses on immunotherapy, regenerative medicine, and gene therapy. (Arterial Network)

|Backed by the Gates Foundation and BMS, Microbiome Immunotherapy Startup Raises $45.5 Million

Vedanta Biosciences Announces Completion of $45.5 Million Series C FinancingRecently, Vedanta Biosciences announced the completion of a $45.5 million Series C financing round. The proceeds from this round will be used to advance the development of Vedanta’s microbiome therapeutic candidate pipeline, including the Phase 1/2 clinical trial of VE416 for the treatment of food allergies and the Phase 1b/2 clinical trial of VE800 in combination with Opdivo for the treatment of advanced or metastatic cancer. (Chuangjianhui)

| Perkbox Completes £13.5 Million Funding Round to Develop Private Health Insurance Services

Recently, VCBeta learned from foreign media sources that Perkbox, a provider of employee experience platforms, raised £13.5 million in a new round of equity financing. The company plans to use the funds to expand its global business, introduce new platform features, and scale up the development and distribution of new products. (VCBeta)

Part 4 Pharmaceutical News and Medical Updates

|Eisai Initiates Phase III Clinical Trial of BAN2401 for Early Alzheimer’s Disease

Eisai Announces Initiation of Global Phase III Clinical Study of BAN2401 in Patients with Early Alzheimer’s Disease. BAN2401 is an anti-amyloid beta protofibril antibody co-developed by Eisai and Biogen. (PR Newswire)

|Hengrui’s Blockbuster Antidepressant Approved for Clinical Trials, with R&D Investment Exceeding 10 Million Yuan

On the 14th, Hengrui Medicine announced that the company and its subsidiary, Shanghai Hengrui Pharmaceutical Co., Ltd., recently received the "Clinical Trial Notification" approved and issued by the National Medical Products Administration for (R)-ketamine hydrochloride nasal spray, and will conduct clinical trials in the near future. (Sina Medical News)

| 1.3 Billion RMB Injection Approved: Low-Molecular-Weight Heparin’s 6.8 Billion RMB Market Welcomes Another Competitor |

On the 14th, Changshan Pharmaceutical announced that the company recently received the "Drug Registration Approval" for Enoxaparin Sodium Injection issued by the National Medical Products Administration. Relevant data shows that in 2017, the sales of Enoxaparin Sodium Injection at public medical institutions in China amounted to RMB 1.343 billion. The original manufacturer of this product is Sanofi, and currently, seven generic drug manufacturers have obtained approval for their products to be marketed. (Menet Network)

|Celgene's New Anti-Cancer Drug Receives FDA Breakthrough Therapy Designation; Marketing Application to Be Submitted by Year-End

Celgene Announces FDA Grants Breakthrough Therapy Designation to Its Novel Anti-Cancer Drug Pomalyst for the Treatment of HIV-Positive Kaposi’s Sarcoma Patients Who Have Previously Received Systemic Chemotherapy, as Well as HIV-Negative Kaposi’s Sarcoma Patients. The Breakthrough Therapy Designation Will Accelerate the Development and Review Process of New Drugs. (WuXi AppTec)

|Reduces Risk of Disease Progression by 85%: FDA Approves New Drug for Treating Diabetes Complications

Regeneron Announces FDA Approval of Eylea for the Treatment of All Stages of Diabetic Retinopathy to Reduce the Risk of Vision Loss in Patients (WuXi AppTec)

| GRAIL’s Liquid Biopsy for Early Detection of Multiple Cancers Receives FDA Approval

GRAIL, a company dedicated to the early diagnosis of cancer, announced that its multi-cancer liquid biopsy test has been granted Breakthrough Device Designation by the FDA. This test will be used for the early detection of multiple cancer types in individuals aged 50 and older. (WuXi AppTec)

|Novel Mechanism! New Schizophrenia Drug Receives FDA Breakthrough Therapy Designation

Sunovion and PsychoGenics Announce FDA Breakthrough Therapy Designation for Investigational New Drug SEP-363856 for the Treatment of SchizophreniaRecently, Sunovion and PsychoGenics announced that their investigational new drug, SEP-363856, has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of schizophrenia. It is poised to become the first novel antipsychotic medication for schizophrenia that does not exert its therapeutic effects through binding to dopamine D2 receptors. (WuXi AppTec)

|The Banlangen of the Monoclonal Antibody World? After HIV and Breast Cancer, Leronlimab Takes on NASH!

CytoDyn recently announced a collaboration agreement with Dr. Daniel Lindne of the Cleveland Clinic to evaluate the ability of leronlimab to prevent non-alcoholic steatohepatitis (NASH) in humanized mouse models. (Sina Medical News)

| Peritech Pharma Obtains Patents in China and Russia

Peritech Pharma, a specialized anorectal pharmaceutical company, announced that the delivery platforms for its two over-the-counter drugs, PP-110 for the treatment of hemorrhoids and PP-120 for the treatment of anal pruritus, have been granted patents applicable in China and Russia. (PR Newswire)

| Focus on Oncology! Servier’s U.S. Subsidiary Begins Operations

Last summer, Servier announced plans to establish a subsidiary in Boston, USA. Less than a year after this announcement, the new company, Servier Pharmaceuticals, officially opened its doors on May 13, with initial operations focused on the development of oncology therapies. The company currently employs approximately 100 people. (Sina Medical News)

|GSP Certificates of Three Pharmaceutical Companies in Guangdong Province Revoked

On the 13th, the Guangdong Provincial Medical Products Administration issued the “Announcement of the Guangdong Provincial Medical Products Administration on the Revocation of GSP Certification Certificates (No. 52, 2019),” revoking the Good Supply Practice (GSP) certifications of three pharmaceutical enterprises, including Shantou Maolin Pharmaceutical Co., Ltd. (Medical Observer Network)

| 576 Licensed Pharmacists' Exam Results Invalidated (List Attached)

Recently, the Yunnan Provincial Personnel Examination Authority released the “Announcement on the Handling of Scores for Some Candidates in the Yunnan Test Area of the 2018 Licensed Pharmacist Qualification Examination.” The Yunnan Provincial Personnel Examination Institute organized verification work at all registration and review sites across the province. Based on the verification results, the scores of the following 576 individuals who took the 2018 Licensed Pharmacist Qualification Examination will be deemed “invalid.” (Saibailan)

| Nature Highlight: Gene Therapy Promotes Cardiac Regeneration

Researchers from King's College London have discovered a therapy that can induce cardiac cell regeneration after a heart attack. (Bioon)

|Research finds that inhibiting ribosome biogenesis is a new approach for treating multi-stage cancer

A study from Uppsala University shows that new ribosome synthesis contributes to cancer cell metastasis. Ribosomes are cellular components responsible for protein production. These findings, published recently in the journal Nature Communications, open up new possibilities for novel therapeutic strategies against advanced-stage cancer. (Bioon)