Hansoh Secures First Domestic Generic Approval for Prostate Cancer Drug; NICE Rejects J&J's Darzalex for Myeloma

【August 30, 2021 / Medical News Digest】Hansoh Pharma secures China's first generic approval for a prostate cancer drug; NICE rejects Johnson & Johnson's myeloma drug Darzalex; Guangdong MPA issues policy to streamline registration and approval; Biocytogen files for Hong Kong IPO……Daily Latest Pharma & Medical News: Your Quick Digest!

Part 1 Policy Brief

Implementation Plan Released on Deepening the “Separation of Licenses and Permits” Reform to Further Stimulate the Development Vitality of Market Entities

On the 30th, the NMPA issued a notice on the 《Implementation Plan of the National Medical Products Administration on Implementing the State Council's Reform of "Separation of Permits and Business Licenses" to Further Stimulate the Vitality of Market Entities》. In accordance with the 《Notice》, a total of 6 enterprise-related administrative licensing items in the drug regulatory sector have been incorporated into the 《Reform List of Central-Level Administrative Licensing Items for Enterprise Business Operations (2021 Free Trade Zone Version)》. Pilot reform efforts will be intensified within the pilot free trade zones, featuring the direct cancellation of approval for 3 items, the conversion of approval to filing for 2 items, and the implementation of a notification and commitment system for 1 item. (NMPA)

National Healthcare Security Administration Issues List of Public Service Items for Centralized Procurement of Drugs and Medical Consumables

On the 30th, in accordance with the *Opinions on Establishing a "Good/Bad Review" System for Government Services to Improve Government Service Quality* (Guo Ban Fa [2019] No. 51) issued by the General Office of the State Council, and pursuant to the requirements of the *Work Plan for Establishing a "Good/Bad Review" System for Healthcare Security Government Services* and the *Working Mechanism of the National Healthcare Security Administration for Deepening the Reform of Delegating Power, Improving Regulation, and Upgrading Services to Transform Government Functions*, the National Healthcare Security Administration issued a notice on the list of public service items for the centralized procurement of drugs and medical consumables. (National Healthcare Security Administration)

Guidelines on the Reform of the Remuneration System in Public Hospitals Released

On the 27th, the National Health Commission issued the *Guiding Opinions on Deepening the Reform of the Remuneration System in Public Hospitals*, marking the official commencement of public hospital compensation system reforms. The *Guiding Opinions* requires localities to broaden funding channels for deepening this reform: first, by unlocking dividends from the reform itself; second, through government financial investment; and third, via hospital cost-control measures. It explicitly stipulates that for hospitals reducing medical insurance fund expenditures due to the standardized implementation of centralized drug procurement and use, their annual total medical insurance budget allocations shall not be reduced. (National Health Commission)

Guangdong Provincial Medical Products Administration Releases Policy on Simplified Registration and Approval

On the 27th, the Guangdong Provincial Medical Products Administration issued the "Announcement on Simplifying the Registration and Approval Process for Traditional Chinese Patent Medicines for External Use Already Marketed in Hong Kong and Macao". The Announcement comprises 15 articles, primarily clarifying the policy's scope of application, basic requirements, specific simplification measures and supplementary requirements for the registration of external-use Chinese patent medicines from Hong Kong and Macao, as well as the relevant responsibilities of enterprises. (Guangdong Provincial Medical Products Administration)

Part 2: Industry Insights

Shanghai Pharma Semi-Annual Report: H1 Net Profit RMB 3.568 Billion, Up 46% Year-on-Year

On the 30th, Shanghai Pharma released its 2021 semi-annual report, reporting operating revenue of RMB 105.237 billion, a year-on-year increase of 20.73%; net profit attributable to shareholders of the listed company was RMB 3.568 billion, up 46.05% year-on-year. (Company Announcement)

Junshi Biosciences Half-Year Report: Operating Revenue RMB 2.114 Billion, Up 267.77% Year-on-Year

On the 30th, Junshi Biosciences released its semi-annual report. During the reporting period, operating revenue reached RMB 2.114 billion, compared to RMB 575 million in the same period last year, a year-on-year increase of 267.77%; net profit attributable to shareholders of the listed company was RMB 9 million, compared to negative RMB 600 million in the same period last year; net profit attributable to shareholders of the listed company after deducting non-recurring gains and losses was negative RMB 113 million, compared to negative RMB 606 million in the same period last year. (Company Announcement)

Heqirui Pharmaceuticals Appoints Dr. Henri Doods as Chief Executive Officer

Recently, Herui Pharmaceuticals announced the appointment of its former President and Head of Clinical Development, Dr. Henri Nico Doods, as Chief Executive Officer. Prior to joining Herui Pharmaceuticals, Dr. Henri Nico Doods served as Senior Vice President and Global Head of Research Beyond Borders (RBB) at Boehringer Ingelheim. (Sina Pharmaceutical News)

Biocytogen's Hong Kong IPO

Recently, according to a disclosure by the Hong Kong Stock Exchange (HKEX), Biocytogen has submitted a listing application. Currently, Biocytogen has established an R&D pipeline comprising 12 products in development, of which 4 antibody molecules have entered the clinical stage, 6 products are in the preclinical stage, and 2 antibody molecules have been out-licensed or partnered. (HKEX)

Part 3: Pharmaceutical & Medical News

NICE Rejects Johnson & Johnson's Myeloma Drug Darzalex

Recently, NICE published a draft guideline recommending against the use of the Darzalex-VTd regimen in the National Health Service for the first-line treatment of adult patients with multiple myeloma who are eligible for autologous stem cell transplantation. Darzalex-VTd is a four-drug regimen comprising Johnson & Johnson’s myeloma drug Darzalex, Takeda’s proteasome inhibitor Velcade, the immunomodulatory agent thalidomide, and the corticosteroid dexamethasone. (Sina Medical News)

Arming Oncolytic Viruses with a "New Weapon" Yields Positive Results in Pancreatic Cancer Treatment

Recently, TILT Biotherapeutics announced that TILT-452, an oncolytic virus expressing an IL-2 variant developed using the company's oncolytic virus immunotherapy platform, achieved positive results in preclinical studies. In a pancreatic cancer hamster model, TILT-452 significantly reduced tumor volume and prolonged animal survival. Meanwhile, histological studies demonstrated that TILT-452 can modulate the tumor microenvironment. (WuXi AppTec)

Bayer Announces Phase 3 Clinical Results for "First-in-Class" Therapy

Recently, Bayer announced that its "first-in-class" therapy Kerendia met the primary endpoint in the Phase 3 FIGARO-DKD clinical trial conducted in patients with type 2 diabetes and chronic kidney disease, reducing the risk of the composite cardiovascular endpoint by 13%. (WuXi AppTec)

Positive Phase II Results for Agenus Anti-PD-1 Monoclonal Antibody in Refractory Cervical Cancer

Recently, Agenus announced that the Phase 2 clinical trial results of its anti-PD-1 monoclonal antibody balstilimab as monotherapy for recurrent/metastatic cervical cancer have been published online in the international peer-reviewed journal *Gynecologic Oncology*. (WuXi AppTec)

Bristol-Myers Squibb PD-1 Inhibitor Approved for New Indication in China

On the 30th, the official website of the NMPA indicated that Bristol-Myers Squibb's PD-1 inhibitor nivolumab injection was granted a drug approval number. According to industry sources, the approved indication is speculated to be for the first-line treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma. (NMPA)

Ono/Takeda "Immunotherapy + Targeted Therapy" Regimen Approved in Japan

Recently, Ono Pharmaceutical and Takeda Pharmaceutical jointly announced that Japanese regulatory authorities have approved the anti-PD-1 therapy Opdivo in combination with the targeted anticancer drug Cabometyx for the first-line treatment of adult patients with unresectable or metastatic renal cell carcinoma. (Bioon)

Japan Approves Merck's Keytruda for Breast Cancer and Colorectal Cancer

Recently, Merck’s blockbuster oncology drug Keytruda secured two additional regulatory approvals in Japan for breast cancer and colorectal cancer, respectively. The therapy now has approved indications for nine cancer types in Japan. (Sina Medical News)

Yuheng Pharmaceutical/WuXi Biologics PD-1 Approved for Marketing

On the 30th, the official website of the NMPA revealed that siprelimab, a fully human innovative anti-PD-1 monoclonal antibody co-developed by Harbin Gloria Pharmaceuticals and WuXi Biologics, has been approved for marketing. It is indicated for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma after two or more prior lines of therapy, making it the sixth China-made PD-1 monoclonal antibody to receive approval. (NMPA)

Hansoh Pharma's Enzalutamide Soft Capsules Approved for Marketing

On the 30th, the NMPA official website indicated that Hansoh Pharma's enzalutamide soft capsules have been granted marketing approval for the treatment of advanced castration-resistant prostate cancer, becoming the first generic drug for prostate cancer. (NMPA)

CSPC Pharmaceutical Group's Oseltamivir Capsules Approved for Marketing

Recently, the official website of the National Medical Products Administration (NMPA) announced that CSPC Pharmaceutical Group's Oseltamivir Capsules have been granted marketing approval. Oseltamivir is a specific neuraminidase inhibitor that prevents the release of mature influenza viruses from host cells, thereby inhibiting viral spread within the human body and exerting a therapeutic effect against influenza. (NMPA)

Fuan Pharmaceutical's Tigecycline for Injection Passes Generic Consistency Evaluation

On the 30th, Fuan Pharmaceutical announced that its wholly-owned subsidiary, Renmin Pharmaceutical, recently received an Approval Notice for Supplementary Drug Application issued by the NMPA, confirming that its product, Tigecycline for Injection, has passed the Quality and Efficacy Consistency Evaluation for Generic Drugs. Tigecycline for Injection is primarily indicated for the treatment of complicated skin and skin structure infections, complicated intra-abdominal infections, and community-acquired bacterial pneumonia in adult patients aged 18 years and above. (Company Announcement)

Chipscreen Biosciences' JAK3 Inhibitor Approved for Clinical Trials in the US

On the 29th, Chipscreen Biosciences announced that its Investigational New Drug (IND) application for CS12192, an independently developed candidate for the treatment of graft-versus-host disease, recently received FDA approval. CS12192 is a highly selective JAK3 kinase inhibitor that also partially inhibits JAK1 and TBK1 kinases. Currently, no drugs of this class are on the market. (Pharma Observer)

Shanghai Pharma's SPH6516 Tablets Receive Implied Approval for Clinical Trial

On the 30th, the official website of the CDE showed that Shanghai Pharmaceuticals' Class 1 innovative drug SPH6516 tablets has been granted implied approval for clinical trials, intended for the treatment of advanced malignant solid tumors. (CDE)

Clinical Trial of Insulin Degludec Injection by Shuanglu Pharmaceutical Approved

On the 30th, Beijing SL Pharmaceutical Co., Ltd. announced that it recently received the 《Notice of Approval for Clinical Trial of Drug》 issued by the NMPA regarding Insulin Degludec Injection. (Company Announcement)