China-U.S. Phase One Trade Deal Strengthens Pharmaceutical Intellectual Property Protections

On January 16, the Ministry of Commerce released the Economic and Trade Agreement between the Government of the People’s Republic of China and the Government of the United States of America. The agreement explicitly states that, to promote innovation and cooperation between China and the United States in the pharmaceutical sector and better meet patient needs, both parties shall provide effective protection and enforcement for intellectual property rights related to pharmaceuticals, including patents and undisclosed test data or other data submitted to meet marketing approval requirements. Sections III and IV of the agreement set forth detailed provisions in this regard.

▲1. China should permit pharmaceutical patent applicants to rely on supplementary data during the patent examination, reexamination, and judicial proceedings to satisfy relevant patentability requirements, including sufficiency of disclosure and inventive step.

▲2. The United States declares that the treatment provided by its existing measures is equivalent to the treatment stipulated in this Article.

▲1. If China permits, as a condition for approving the sale of drugs, including biologics, that persons other than the original submitter of safety and efficacy data may rely on prior evidence or information regarding the product’s safety and efficacy (such as evidence of prior approval for sale in China or other regions) to obtain approval, China shall provide:

(a) A system for issuing notice to a patent holder, licensee, or market approval holder when another party is seeking to sell the product during the term of any applicable patent covering the approved product or its approved method of use;

(b) the patent holder referred to in item (c) has had sufficient time and opportunity to seek available remedies before selling the allegedly infringing product; and (c) judicial or administrative proceedings and expedited remedial procedures, such as preliminary injunctions or equivalent effective provisional measures, to timely resolve disputes concerning the validity or infringement of applicable patents related to an approved drug or its approved methods of use.

▲2. China shall establish a national pharmaceutical system consistent with paragraph 1, including providing causes of action to allow patent holders, licensees, or marketing approval holders to seek civil judicial proceedings prior to the marketing approval of alleged infringing products, for litigation and expedited remedies to resolve disputes concerning the validity or infringement of applicable patents. China may also provide administrative procedures for the resolution of such disputes.

▲3. The United States declares that the treatment provided by its existing measures is equivalent to the treatment stipulated in this Article.

▲1. Both parties shall provide for the extension of patent terms to compensate for unreasonable delays that occur during the patent grant or drug marketing approval process.

▲2. China should stipulate that:

(a) China shall extend the patent term at the request of the patentee to compensate for unreasonable delays that occur during the granting of the patent, provided such delays are not attributable to the applicant. For the purposes of this Article, unreasonable delays shall include, at a minimum, patent delays exceeding four years from the date of filing in China, or exceeding three years from the date of the request for substantive examination.

(b) At the request of the patent owner, China shall make adjustments to the term of a patent covering a new pharmaceutical product that has been approved for marketing in China, or a patent covering a method of using or manufacturing such an approved product, to compensate the patent owner for unreasonable curtailment of the effective patent term resulting from the marketing approval process related to the first commercial use of that product in China. Any such adjustment shall confer upon the patented claims for the product, its method of use, or its method of manufacture all exclusive rights originally granted under the issued patent, subject to the same limitations and exceptions applicable to the approved product and the approved method of use of the product. China may limit the duration of such adjustment to no more than five years, and may limit the resulting effective patent term to no more than 14 years from the date of approval in the Chinese market.

▲3. The United States declares that the treatment provided by its existing measures is equivalent to the treatment stipulated in this Article.

Genomics Company Color Completes $75 Million Series D Financing to Continue Developing Genetic Testing Platform

On November 16, Color, a precision genomics company, announced the completion of a $75 million Series D financing round. The round was co-led by venture capital firms T. Rowe Price and Viking Global Investors. The proceeds will be used to further develop its genetic testing platform and apply genomic testing technologies to the field of preventive healthcare.

WuXi Biologics Acquires a Bayer Biologics Manufacturing Plant in Germany

On January 16, WuXi Biologics and Bayer jointly announced that they had reached an agreement under which WuXi Biologics will take over the operations of a biologics manufacturing facility in Leverkusen, Germany, purchase related equipment, and assume a long-term lease agreement associated with the site. Under the proposed manufacturing collaboration agreement, the facility will be operated by WuXi Biologics and serve as a supplemental manufacturing service provider for Bayer’s product Kovaltry® (recombinant antihemophilic factor). Subject to customary closing conditions, the transaction is expected to be completed within the coming months; financial details were not disclosed.

BMS Immunotherapy Combination Opdivo + Yervoy Receives FDA Priority Review for First-Line Treatment of NSCLC Patients

On January 15, Bristol Myers Squibb (BMS) announced that the U.S. Food and Drug Administration (FDA) had accepted its supplemental Biologics License Application (sBLA) and granted it Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of May 15, 2020. The sBLA seeks approval for the combination therapy of Opdivo (nivolumab) and Yervoy (ipilimumab) as a first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC) whose tumors have no EGFR or ALK genomic aberrations.

Pharmaceutical Company Clovis’ Anti-Cancer Drug Rubraca Receives FDA Priority Review for Treating BRCA-Mutated Prostate Cancer

On January 15, pharmaceutical company Clovis Oncology announced that the U.S. Food and Drug Administration (FDA) had accepted a supplemental New Drug Application (sNDA) for Rubraca (rucaparib), a targeted anticancer drug, and granted it Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of May 15, 2020. Rubraca is indicated as a monotherapy for the treatment of adult patients with BRCA1/2-mutated, recurrent, metastatic castration-resistant prostate cancer (CRPC).

Pharmaceutical Company Recordati’s Cortisol Synthesis Inhibitor Isturia Approved by EU for Treating Cushing’s Syndrome

On the 15th, Italian pharmaceutical company Recordati announced that the European Commission (EC) has granted marketing authorization for the orphan drug Isturia® (osilodrostat), indicated for the treatment of endogenous Cushing’s syndrome (CS) in adults. The active pharmaceutical ingredient of Isturia® is osilodrostat, a cortisol synthesis inhibitor that acts by inhibiting 11β-hydroxylase, the enzyme responsible for the final step in adrenal cortisol biosynthesis.

Astellas’ Second-Generation FLT3 Inhibitor Xospata Approved in Canada

On January 15, Japanese pharmaceutical company Astellas announced that Health Canada had approved the targeted anticancer drug Xospata (gilteritinib). This once-daily oral medication is indicated as a monotherapy for the treatment of adult patients with relapsed (disease recurrence) or refractory (drug-refractory) acute myeloid leukemia (AML) harboring FLT3 mutations (FLT3mut+).

Alexion’s Long-Acting C5 Complement Inhibitor Ultomiris Enters Phase III Clinical Trial for ALS Treatment

On January 15, Alexion Pharmaceuticals announced plans to initiate a pivotal Phase III study evaluating Ultomiris (ravulizumab) for the treatment of amyotrophic lateral sclerosis (ALS). Named CHAMPION-ALS, this 50-week, randomized, double-blind, placebo-controlled, multicenter, global Phase III trial aims to assess the efficacy and safety of Ultomiris in a broad ALS patient population.

BGI Genomics Says Subsidiary Develops Nucleic Acid Test Kit for Novel Coronavirus Outbreak in Wuhan

Recently, BGI Genomics Co., Ltd. announced on its official Weibo account that in response to the outbreak of the novel coronavirus in Wuhan, its subsidiary, Shenzhen Huada Yingyuan Medical Technology Co., Ltd. (formerly the Infection Prevention and Control Division), urgently mobilized its research and production resources and successfully developed a nucleic acid detection kit for the novel coronavirus at the earliest opportunity. The kit is now available for use by disease control and prevention agencies and medical institutions at all levels.

Ping An Group Launches “Step-by-Step Treasure Hunt” Cancer Mutual Aid Plan

On January 15, Ping An Group’s cancer mutual aid plan, “Bu Bu Duo Bao,” was officially launched on the Ping An Good Doctor app. The plan claims that users can join at no cost and may receive up to RMB 3 million in cancer treatment reimbursement. To date, more than 53,000 people have joined.

Guizhou Bailing’s Compound for Pimotidine Mesylate for Injection Granted Invention Patent

On January 15, Guizhou Bailing announced that the Company had received an invention patent certificate issued by the China National Intellectual Property Administration. The patent, titled “Purine-based N-hydroxypyrimidine carboxamide derivatives and their preparation methods and uses,” is a compound patent for the Class 1.1 new chemical drug project, Puysita Mesylate for Injection, jointly developed by the Company and West China Hospital of Sichuan University for the treatment of hematologic malignancies.

Boruida Biology Granted Three Invention Patents

Recently, Wuhan Boruida Biotechnology Co., Ltd. was granted three invention patents. The authorized patents are: "A Human Chimeric Antigen Receptor for Treating Hematologic Malignancies and Its Application," "Combined Application of Oncolytic Viruses and CAR-T for the Treatment of Solid Tumors," and "A CAR-NK Cell, Its Preparation Method, and Application." These achievements highlight the company's strong emphasis on intellectual property and its robust R&D capabilities in CAR-T immune cell therapy for both solid tumors and hematologic malignancies.

GenScript and Genopis Sign Strategic Cooperation Agreement for GMP Plasmid Production Services

On January 14, GenScript Biotech announced the signing of a strategic cooperation agreement with Genopis for GMP plasmid production services. Through this strategic partnership, GenScript and Genopis have established a revenue-sharing agreement aimed at jointly developing, marketing, and manufacturing GMP-grade plasmids on a global scale.

*Nature*: Research Team at Tongji University Discovers New Mechanism Underlying the Pathogenesis of Tuberculosis Infection

On January 15, Tongji University held a press conference to announce a new discovery from the collaborative research between Professor Ge Baoxue’s team at Shanghai Pulmonary Hospital, Tongji University, and Academician Rao Zihe’s team at ShanghaiTech University. The study revealed that a protein secreted by Mycobacterium tuberculosis exhibits remarkable “cunning” by hijacking human host proteins to attack the body’s own immune defenses, thereby enhancing its virulence and leading to the development of tuberculosis. These medical research findings were published online in the prestigious international academic journal Nature.