Two Domestic Class 1 Oncology New Drugs from RemeGen and Zelgen Biopharmaceuticals Approved for Market Launch

【June 9, 2021 / Pharmaceutical News Digest】Pfizer's 20-valent pneumococcal conjugate vaccine approved by US FDA; FDA delays review of Incyte's Jakafi application by 3 months; 3D electronic laparoscope approved for market launch; Blue Sail Medical Vice President Yang Fan resigns...Daily Fresh Pharmaceutical & Medical News: Quick Briefs to Keep You Informed!

Part 1 Policy Briefing

Three Departments Jointly Issue Notice on Further Raising Funding Standards for Resident Medical Insurance in 2021

On the 8th, the National Healthcare Security Administration, the Ministry of Finance, and a third department jointly issued a notice on improving the unified basic medical insurance system for urban and rural residents and the critical illness insurance system, and effectively ensuring medical security for urban and rural residents. The notice outlines eight key requirements, primarily focusing on strengthening medical insurance payment management, as well as enhancing the centralized volume-based procurement and price management of drugs and medical consumables. (National Healthcare Security Administration)

National Health Commission: Establishes Expert Group to Advance Tiered Diagnosis and Treatment and Medical Consortium Development

On June 7, the National Health Commission issued a Notice on the Establishment of an Expert Group to Advance the Development of the Tiered Diagnosis and Treatment System and Medical Consortia, which will conduct assessments and supervise the implementation of related work across China. (National Health Commission)

Announcement of the National Medical Products Administration on the Cancellation of a Medical Device Registration Certificate

On June 9, the National Medical Products Administration issued an announcement that, in accordance with the provisions of the Measures for the Administration of Medical Device Registration and upon the application of the enterprise, the medical device registration certificate for Nikon Corporation, Registration Certificate No.: Guo Xie Zhu Jin 20172226595, Product Name: Biological Microscope, is hereby cancelled. (National Medical Products Administration)

Genomic Sequencing Similarity Exceeds 98% Among All Positive Cases in Guangzhou

On June 9, Li Tiegang, Deputy Director of the Disease Control Division of the Guangzhou Municipal Health Commission, stated that the genome sequence similarity among all positive cases in Guangzhou currently exceeds 98%, indicating that all positive cases belong to the same transmission chain. Further source tracing will require additional time. (Guangzhou Municipal Health Commission)

Part 2 Industry & Economy Observation

Bluesail Medical Vice President Yang Fan Resigns

On June 8, Blue Sail Medical announced in a disclosure on the Shenzhen Stock Exchange that Mr. Yang Fan, Vice President of the company, has tendered his resignation due to personal reasons. Following his resignation, he will not hold any positions within the company or its subsidiaries. The handover and transition of his responsibilities have been smoothly completed, and his departure will not adversely affect the company's normal operations and production activities. (Blue Sail Medical Announcement)

`Baiyang Pharmaceutical IPO Plans to Publicly Issue 52.6 Million Shares`

On June 9, Baiyang Pharmaceutical released the Preliminary Inquiry and Roadshow Announcement for its initial public offering and listing on the ChiNext Board. The company plans to publicly issue 52.6 million shares, accounting for 10.02% of the total share capital post-issuance. All shares to be issued are new shares, and the existing shareholders of the issuer will not publicly offer their held shares. Following this public offering, the company's total share capital will be 525.1 million shares. (Sina Pharmaceutical News)

PHARSCIN PHARMA: Signs "Framework Agreement on Strategic Cooperation for Innovative Drug Development" with PHIL RIVERS TECHNOLOGY Co., Ltd. and Other Parties

On June 9, PHARSCIN PHARMA announced that the Company, together with PHIL RIVERS TECHNOLOGY Co.,Ltd and the Western Institute of Computing Technology, Chinese Academy of Sciences, signed the 《Strategic Cooperation Framework Agreement on Innovative Drug Development》 in Beijing on June 9, 2021. The three parties unanimously agreed to establish a win-win strategic cooperative relationship on the basis of complementary advantages, mutual benefits, and common development. (PHARSCIN PHARMA Announcement)

Haoyuan Pharma Listed on the STAR Market

On June 8, Haoyuan Pharma was listed on the STAR Market under the stock code 688131. A total of 18.6 million RMB-denominated ordinary shares were issued in this offering at an issue price of RMB 64.99 per share, raising a total of RMB 1.209 billion. (Haoyuan Pharma announcement)

VWISE Medical Completes Nearly RMB 100 Million Series A+ Funding Round

On June 9, Suzhou VIVIS Medical Technology Co., Ltd. completed a nearly 100 million RMB Series A+ financing round, led by Yuanhe Origin with participation from Nuowei Medical. (VCBeat)

Part 3: Pharma & Medical News

Next-Generation ADC Meets Phase 3 Clinical Endpoints in HER2-Positive Breast Cancer Patients

On June 8, Byondis announced that its next-generation investigational antibody-drug conjugate (ADC), trastuzumab duocarmazine, met the primary endpoint of progression-free survival (PFS) in the Phase 3 TULIP clinical trial. In patients with previously treated, unresectable locally advanced or metastatic HER2-positive breast cancer, the drug demonstrated a statistically significant improvement in PFS compared to physician's choice of therapy. (WuXi AppTec)

UK NICE Approves Roche's Tecentriq for First-Line Treatment of PD-L1-Positive Lung Cancer

The UK's National Institute for Health and Care Excellence (NICE) recently issued guidelines recommending Roche's anti-PD-L1 therapy Tecentriq as monotherapy for the first-line treatment of metastatic non-small cell lung cancer (NSCLC). The specific eligible population for Tecentriq comprises adult patients with metastatic NSCLC whose tumors express PD-L1 on at least 50% of tumor cells or at least 10% of tumor-infiltrating immune cells, and who do not harbor EGFR or ALK genomic aberrations. (Sina Medical News)

Pfizer's 20-Valent Pneumococcal Conjugate Vaccine Approved by U.S. FDA

Pfizer announced today that the U.S. FDA has approved Prevnar 20 (20-valent pneumococcal conjugate vaccine) for use in adults aged 18 years and older to prevent invasive disease and pneumonia caused by the 20 pneumococcal serotypes included in the vaccine. (Sina Pharma News)

Novel Alpha-Radiation Cancer Therapy Receives FDA Breakthrough Device Designation

Recently, Alpha Tau Medical announced that its alpha radiation cancer therapy, Alpha DaRT, has received Breakthrough Device Designation from the U.S. FDA for the treatment of cutaneous and oral squamous cell carcinoma in patients with no curative standard of care. (Chuangjianhui)

FDA Delays Review of Incyte's Jakafi Application by 3 Months

Affected by the ripple effect of negative safety signals associated with Pfizer’s Xeljanz, Incyte announced on Tuesday that the FDA has also delayed the approval decision date for Jakafi’s regulatory application for the treatment of steroid-refractory chronic graft-versus-host disease by three months, with the new target action date for Jakafi in this indication set for September 22. (Sina Pharma News)

First! RemeGen's Disitamab Vedotin for Injection Conditionally Approved for Marketing

On June 9, the National Medical Products Administration (NMPA) issued an announcement conditionally approving Disitamab Vedotin for Injection, submitted by RemeGen, for marketing. This drug is an innovative antibody-drug conjugate independently developed in China, indicated for the treatment of patients with HER2-overexpressing locally advanced or metastatic gastric cancer who have received at least two prior lines of systemic chemotherapy. (NMPA)

NMPA Approves Donafenib Tosylate Tablets for Marketing

On June 9, the official website of the National Medical Products Administration (NMPA) announced that the NMPA recently approved, through the priority review and approval procedure, the marketing of Donafenib Tosylate Tablets, a Class 1 innovative drug submitted by Suzhou Zelgen Biopharmaceuticals Co., Ltd. This drug is an innovative product independently developed in China with independent intellectual property rights. It is indicated for patients with unresectable hepatocellular carcinoma who have not previously received systemic therapy. (National Medical Products Administration)

Another COVID-19 Inactivated Vaccine Approved for Use in China: Full Vaccination Requires 2 Doses

On June 9, the first batch of the KeweiFu novel coronavirus inactivated vaccine, independently developed by the Institute of Medical Biology, Chinese Academy of Medical Sciences (CAMS), was launched and supplied for emergency use in China. The immunization schedule for this COVID-19 inactivated vaccine is consistent with that of similar vaccines, requiring a two-dose regimen with an interval of 2 to 4 weeks between doses. It is currently approved for individuals aged 18 years and above. (Sina Medical News)

3D Electronic Laparoscope Approved for Marketing

On June 8, the National Medical Products Administration (NMPA) issued an announcement stating that, upon review, it has approved the registration application for the innovative product "3D Electronic Laparoscope" manufactured by MicroPort MedBot (Shanghai) Co., Ltd. It is reported that the device provides imaging via a video monitor for observation, diagnosis, photography, or treatment of the thoracic and abdominal cavities. (NMPA)

Tetrabenazine Tablets Nearing Approval for the Treatment of Huntington's Disease

Recently, the import application for tetrabenazine tablets, a Class 5.1 new drug from Shandong Bausch & Lomb Freda Pharmaceutical Co., Ltd., has entered the administrative review phase. It is expected to be officially approved shortly, becoming the second drug approved in China for the treatment of Huntington's disease. (CPhI Online)

Huabang Health's Methylprednisolone Sodium Succinate for Injection Passes Generic Drug Consistency Evaluation

On June 9, Huabang Health announced that its wholly-owned subsidiary, Huabang Pharmaceutical, recently received the "Notice of Approval for Supplementary Drug Application" for the chemical drug Methylprednisolone Sodium Succinate for Injection, approved and issued by the National Medical Products Administration (NMPA). The drug has passed the Generic Drug Consistency Evaluation. Clinically, it is generally used for the acute and critical phases in critically ill patients, as well as for maintenance therapy following emergency treatment. (Announcement from Huabang Health)

Bayer's Innovative Cell and Gene Therapies Enter Clinical Trials

On June 8, Bayer announced that its subsidiary BlueRock Therapeutics successfully transplanted DA01, a pluripotent stem cell-derived dopaminergic neuron therapy, into a Parkinson’s disease patient for the first time in a Phase 1 clinical trial. Meanwhile, its subsidiary Asklepios Biopharmaceuticals is also advancing a gene therapy for Parkinson’s disease. (WuXi AppTec)

Janssen's BCMA/CD3 Bispecific Antibody Approved for Clinical Trials in China

According to a public notice on the official CDE website, teclistamab injection, a Class 1 biological innovative drug developed by Janssen (a Johnson & Johnson company), has been approved for clinical trials for the treatment of multiple myeloma. Reportedly, it is a bispecific antibody targeting B-cell maturation antigen (BCMA) and the CD3 receptor on the surface of T lymphocytes. (CDE Official Website)