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Electronic Arts pledges free use for five accessibility patents [ 2021-10-22 ]
Electronic Arts pledges free use for five accessibility patents Recently, Electronic Arts (EA) announced a patent pledge that gives other companies and developers free access to five of its current accessibility-related patents and technology. The company promised not to enforce against any party for infringing any of the listed patents. Instead, EA hopes to encourage “innovation” and build new features that make video games more inclusive on a much larger scale by opening up the patents.  Electronic Arts (EA) is an American video game company founded in 1982. The company owns many popular and famous games, such as The Sims, SimCity, Apex Legends, Madden NFL and FIFA. Each of the games has more than 30 or 50 million sales volume. Significantly, esports involves FIFA and Apex Legends into the event list. Apex Legends has up to 1 billion players, and it is so popular that it has a Switch version. Within the freely available patents, one of which grabs everyone’s attention -- Apex Legends’ ping system (patent No. US 11097189). The ping system in Apex Legends, which excellently allows players to make communication and teamwork quick and easy without hearing or speaking, has been praised both as an impressive alternative to voice chat and as a great accessibility feature for players with a variety of disabilities.  The other patents include the technology widely used in the FIFA and Madden NFL. The innovations can automatically detect and modify colors (patent No. US 10118097 and CN 107694092) and contrast ratios (patent No. US 10878540) to improve gamers’ visibility with colorblindness and low vision. Furthermore, one of the patents relates to personalized sound technology, helping players with hearing issues by modifying or creating music based on their preferences (patent No. US 10790919).   The code of the mentioned technology is published on EA’s GitHub, and it is open to all developers. Thus, the developers can use it or adapt it for their games without spending the costs to research. It is good that EA shares the patents for free use and aims to create an accessibility-increased gaming environment for players. However, it is not “unconditional” to use the listed patents. In the pledge, EA mentioned that it may terminate the promise for a specific party which files a patent infringement lawsuit or other patent proceedings against EA. We can see parts of EV’s ambition behind the announcement—to build a large game developer league and a community of shared interests.     Reference: https://www.ea.com/commitments/positive-play/accessibility-patent-pledge https://iknow.stpi.narl.org.tw/Post/Read.aspx?PostID=14562 https://www.polygon.com/22639469/apex-legends-electronic-arts-patent-pledge-accessibility-developers https://www.theverge.com/2021/8/24/22638535/ea-accessibility-patent-pledge-apex-legends-ping-system https://www.gamesradar.com/ea-secures-a-patent-for-the-apex-legends-ping-system-and-its-giving-it-away-for-free/ https://dotesports.com/apex-legends/news/apex-legends-ping-system-is-now-patent-free-for-accessibility https://www.nintendolife.com/news/2021/08/apex_legends_ping_system_now_patent-free_as_ea_announces_accessibility_pledge Recently, Electronic Arts (EA) announced a patent pledge that gives other companies and developers free access to five of its current accessibility-related patents and technology. The company promised not to enforce against any party for infringing any of the listed patents. Instead, EA hopes to encourage “innovation” and build new features that make video games more inclusive on a much larger scale by opening up the patents.    Electronic Arts (EA) is an American video game company founded in 1982. The company owns many popular and famous games, such as The Sims, SimCity, Apex Legends, Madden NFL and FIFA. Each of the games has more than 30 or 50 million sales volume. Significantly, esports involves FIFA and Apex Legends into the event list. Apex Legends has up to 1 billion players, and it is so popular that it has a Switch version.   Within the freely available patents, one of which grabs everyone’s attention -- Apex Legends’ ping system (patent No. US 11097189). The ping system in Apex Legends, which excellently allows players to make communication and teamwork quick and easy without hearing or speaking, has been praised both as an impressive alternative to voice chat and as a great accessibility feature for players with a variety of disabilities.    The other patents include the technology widely used in the FIFA and Madden NFL. The innovations can automatically detect and modify colors (patent No. US 10118097 and CN 107694092) and contrast ratios (patent No. US 10878540) to improve gamers’ visibility with colorblindness and low vision. Furthermore, one of the patents relates to personalized sound technology, helping players with hearing issues by modifying or creating music based on their preferences (patent No. US 10790919).   The
The forum on "China's Intellectual Property-related Reform Measures and New Trends in Patent Litigation" will be held successfully! [ 2021-10-22 ]
The forum on "China's Intellectual Property-related Reform Measures and New Trends in Patent Litigation" will be held successfully! In response to the call for building a strong country with intellectual property rights, at 2 o'clock in the afternoon of October 21, the forum on "China's reform measures related to intellectual property rights and new trends in patent litigation" will be successfully held in Nanjing Jiangbei New District Industrial Technology Research and Innovation Park. The event was hosted by the Science and Technology Innovation Bureau of Nanjing Jiangbei New Area Management Committee, Nanjing Jiangbei New Area Industrial Technology Research and Innovation Park, Nanjing Intellectual Property Rights Protection Assistance Center Jiangbei New District Center, Nanjing Huaxun Intellectual Property Consultant Co., Ltd., Nanjing Intellectual Property Co-organized by the Protection Center (Nanjing Intellectual Property Rights Protection Assistance Center), Taiwan Pharmaceutical Development Association, and Gene Online. The director of Nanjing Intellectual Property Protection Center, Mou Xiaojian, delivered a speech. Director Mu expressed his warm congratulations on the holding of this event and introduced in detail the new pattern of intellectual property protection in Nanjing. He said: At present, Nanjing has implemented a rights protection assistance network in the municipal area. With full coverage, Nanjing Intellectual Property Protection Center is willing to closely communicate and interact with Nanjing's innovation entities, and provide relevant public welfare services such as rapid pre-review, rapid rights protection, and comprehensive utilization for enterprises in need. In addition, Huang Funan, CEO of Gene Online, was unable to come to congratulate due to the epidemic, and recorded a congratulatory video. In the video, he said: China Innovative Pharmaceuticals has already made many outstanding achievements on the international stage, and these are inseparable from intellectual property rights. The support of the company can also show the importance of intellectual property rights to biotechnology and pharmaceutical companies. This event invites four industry experts to focus on China's reform measures related to intellectual property rights and new trends in patent litigation, discuss with companies and universities, and make arrangements in advance. Dr. Qingchen Hou, general manager of Nanjing Huaxun Intellectual Property Consulting Co., Ltd., introduced the "Guidelines for Building a Powerful Country with Intellectual Property Rights (2021-2035)" and explained his views from four aspects: background, strategic layout, overall requirements, and organizational guarantees. . Subsequently, a detailed analysis of China's patent linkage system was carried out, and compared with the same types of cases at home and abroad, questions were raised: Why should we reward the first person who successfully challenged patents? Not the first person to file a P4 application? And have a series of discussions with you. Director Jiang Haijun of the Intellectual Property Protection Legal Committee of the Nanjing Lawyers Association gave a speech on three points: the problems after the amendment of the patent law, the enforceability of the amount of compensation, and the legal conflicts related to service inventions. Regarding the patent right evaluation report, he emphasized that the patentee, interested party or accused infringer can also proactively issue a patent right evaluation report. "Patent is a work of art that combines technology and law" is a message shared by Mr. Feng Tao from Jiangsu Junbo Law Firm at this event. Mr. Feng analyzes the big data of Chinese patent litigation cases through graphs and examples. Explore. The last topic of the event was shared by Guo Huangying, Intellectual Property Manager of Nanjing Huaxun Intellectual Property Agency (General Partnership)-China's Patent Infringement Judgment Principles and New Developments. Manager Guo explained to everyone the principles of patent infringement judgment and the necessity of patent infringement search and analysis before producing and selling products. In the intellectual property industry, ECCOM has been providing high-quality and professional comprehensive intellectual property services to enterprises and universities one step at a time. It also hopes that under the leadership of the state and the government, it will contribute to the building of a strong intellectual property nation in China. Make a contribution.
Types of patents that are easily overlooked- Design Patent [ 2021-09-26 ]
Types of patents that are easily overlooked- Design Patent In recent years, as the public’s awareness of intellectual property has increased, people have begun to consciously use the patent law to protect their intellectual property rights. However, in the process of implementation, they often only focus on invention patent and utility model patent, and tend to ignore the protection of design patent. Recently, Midea sued Haotaitai for two models of CXW-300-D998 and CXW-300-D908 Haotaitai brand range hoods In the case of suspected infringement of its design patent (patent number: ZL201930621598.X), the Guangzhou Intellectual Property Court made a first-instance judgment after hearing that it determined that the two products of Haotaitai constituted infringement, and ordered it to immediately stop the infringement and compensate Midea, The company's economic losses and reasonable expenses totaled 360,000 yuan. In fact, appearance infringement cases have occurred from time to time before, such as: "Molly" blind box design patent case, "Siemens" switch design patent infringement dispute case received a compensation of 6 million yuan, three Casio watch design patents were infringed Received a compensation of 8.8 million yuan and so on. The reason why people ignore the protection of design patents, in the final analysis, is that they have insufficient knowledge of design patents. Today, let's take a look at what is protected by design patents and what rights protections can we apply for? Design patent definition: Article 2 of the "Patent Law", design patent, refers to a new design that is aesthetically pleasing and suitable for industrial applications based on the shape, pattern, or combination of products, and the combination of color, shape, and pattern. Protected range: The shape of the product; the pattern of the product; the shape and pattern of the product; the shape and color of the product; the pattern and color of the product; the shape, pattern and color of the product. Protection period: The term of protection for design patent rights is 15 years, calculated from the date of filing. What are the conditions for applying for a design patent? The design should be aesthetically pleasing Appearance patents should be suitable for industrial applications The design patent application should be novel The design patent application should be inventiveness What are the advantages and functions of design patents? Protect the rights and interests of enterprises in product designs and fight against infringements in market competition. To enhance brand value, the quality and quantity of patents are the embodiment of the company's innovation ability and core competitiveness. Receive consumer recognition. If a company's new product appearance is filed for a patent in a timely manner, its appearance design will enjoy the exclusive right. Nowadays, consumers often choose products with trendy and beautiful appearance when buying their products. Applying for a design patent is a necessary condition for applying for a high-tech enterprise.
Colopl Settles Patent Infringement Lawsuit with Nintendo by Paying $30 Million [ 2021-09-09 ]
Colopl Settles Patent Infringement Lawsuit with Nintendo by Paying $30 Million   This August, Nintendo and a game developer Colopl announced that they have settled for patent infringement regarding White Cat Project (Shironeko Project in Japanese), a smartphone game developed by Colopl. Although both companies did not publicly share exact details of the settlement, at least it is sure that Colopl agreed to pay 3.3 billion yen (about US$30.2 million) as the settlement fee for the proceedings, including the future license of Nintendo's patents.    How did the battle begin?  Being developed and published by a Japanese game developer, Colopl, White Cat Project is a free-to-play action role-playing game for Android and iOS systems. The mobile game was launched in July 2014 as well as got a television anime adaptation in 2020. It is incredibly popular to have more than 50 million downloads. Furthermore, the game is set to receive a Switch version titled "Shironeko New Project".    In September 2016, Nintendo noted the Colopl's game and considered that the game had infringed on several of Nintendo's technology patents. The two companies communicated with each other for over a year; however, Nintendo did not accept the explanations from Colopl, and Nintendo filed a lawsuit against Colopl at the beginning of 2018.    Nintendo claimed that Colopl infringed 6 of its patents. These patents protect touch-screen joystick functionality (patent no. JP3734820), multiplayer connectivity (patent no. JP5595991, JP6271692), confirmation screens in sleep mode (patent no. JP4010533), character attacks based on touch input locations (patent no. JP4262217), and a shadow effect placed on characters hidden behind the game geometry (patent no. JP3637031).   These patents almost cover various ways of game technology, especially the patent  JP5595991 and JP6271692. Their patent family is wide-reaching, and many divisional applications of the family are pending in Japan. They protect a communication game system and its related devices. It is not easy to detect the patent's existence and boundary since this kind of hardcore technique is so common in the gaming field and our daily lives.     The five-year patent war has been settled.  After a five-year dispute, the situation appeared to turn in Nintendo's favor as the Switch maker increased its monetary demands, which convinced Colopl to strike a deal that lets it use the disputed patents. Furthermore, a Switch version of White Cat Project remains in the works at Colopl.    With the extraordinary losses of Colopl, the legal battle between the two companies came to an end.  
The First COVID-19 Vaccine Approved by FDA [ 2021-08-27 ]
The First COVID-19 Vaccine Approved by FDA On August 23, 2021, the U.S. Food and Drug Administration approved Pfizer-BioNTech COVID-19 Vaccine. As the first COVID-19 vaccine approved by FDA, it has been marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. Since Dec. 11, 2020, this vaccine has been available under emergency use authorization (EUA) in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. Comirnaty contains messenger RNA (mRNA), which is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty is administered as a series of two doses, three weeks apart. The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The Comirnaty Prescribing Information includes a warning about these risks. To support the FDA’s approval decision, the agency analyzed effectiveness and safety data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death. The FDA’s approval of this vaccine is a milestone as people all over the world continue to battle the COVID-19 pandemic. As the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product. The Pfizer-BioNTech COVID-19 Vaccine now becomes Pfizer’s highest-selling product. The sales revenue reached 7.8 billion US dollars in the second quarter. The cumulative sales in the first half of the year were 11.3 billion US dollars. It is expected to achieve approximately 33.5 billion US dollars in revenue for the whole year. In the Greater China region, Fosun Pharma announced a strategic cooperation agreement with BioNTech as early as March 16, 2020. Fosun Pharma was authorized by BioNTech to exclusively develop and commercialize vaccine products against COVID-19 in mainland China, Hong Kong, Macau, and Taiwan based on its proprietary mRNA technology platform. In the process of global joint research and development, Fosun Pharma has conducted in-depth cooperation with BioNTech in clinical research, pharmacological data, and pharmacovigilance. The successful development of Comirnaty contains the wisdom of the Chinese scientific research team. On May 9, 2021, Fosun Pharma stated that it plans to invest in a joint venture with BioNTech to realize the localized production and commercialization of mRNA COVID-19 vaccine products. Once the approval is passed, Fosun Pharma and BioNTech will quickly promote domestic localized production and make a domestically produced mRNA vaccine.
Can artificial intelligence (AI) be patent inventors? [ 2021-08-16 ]
Can artificial intelligence (AI) be patent inventors? Have you ever been aware of the inventors’ existence in patent applications?   During the patent application process or in patent wars, the main point always focuses on patentees and patents themselves. However, this time inventors are in the spotlight. The decisions from the Companies and Intellectual Property Commission of South Africa and the Federal Court of Australia bombarded the patent world. It is about how technology challenges patent law. On 28th July, the Companies and Intellectual Property Commission of South Africa granted the first patent on an invention created by an artificial intelligence (AI) inventor, DABUS. South Africa becomes the first country which recognizes AI as an inventor.   DABUS (device for the autonomous bootstrapping of unified sentience) is an AI system created by Stephen Thaler, an expert in the field of AI. The system imitates human brainstorming and creates new inventions, and it is capable of functioning independently and complexly. DABUS invented an emergency warning light and a food container that improves grip and heat transfer. Thaler has filed the patent application listing DABUS as the inventor in patent offices around the world, including the US, the UK, Europe, Australia, and South Africa; however, only South Africa granted the patent. The other countries stated that inventors on a patent application must have “legal capacity” or must be “natural persons”.   On the other hand, on 30th July the Federal Court of Australia ruled an artificial intelligence (AI) system can be an inventor under the Australian Patents Act. The decision in Thaler v Commissioner of Patents [2021]  FCA 879 is the first judicial determination in favor of AI inventorship.   The Honorable Justice Beach said, “First, an inventor is an agent noun; an agent can be a person or thing that invents. Second, so to hold reflects the reality in terms of many otherwise patentable inventions where it cannot sensibly be said that a human is the inventor. Third, nothing in the Act dictates the contrary conclusion.”   The Justice considered that patentable inventions are not all created by humans, and further explained, “……that position confuses the question of ownership and control of a patentable invention including who can be a patentee. …… Only a human or other legal person can be an owner, controller or patentee. That of course includes an inventor who is a human. But it is a fallacy to argue from this that an inventor can only be a human. An inventor may be an artificial intelligence system, but in such a circumstance could not be the owner, controller or patentee of the patentable invention.” Following the court’s decision, Thaler’s application will be sent back to the Australian Patent Office to reconsider the reasons for their rejection.   Whether AI can be listed as an inventor in AI-generated inventions is still debating. In addition, based on the decisions from South Africa and Australia, they brought us back to rethinking not only inventors’ position but also what inventors mean in the patent field.
Huawei and Verizon, patent litigation to reconciliation [ 2021-07-28 ]
Huawei and Verizon, patent litigation to reconciliation Huawei and Verizon Communications have agreed to settle two lawsuits alleging patent infringement, it was reported on July 12, Beijing time. Over the past 20 years, Huawei has reportedly conducted extensive cross-licensing negotiations with major patent holders in the telecom industry, and has signed more than 100 patent licensing agreements with major ICT manufacturers in the United States, Europe, Japan and South Korea. Together of the two separate cases, already in Texas last week trial. But late on Sunday local time, Huawei and Verizon filed joint motions in two US courts to dismiss both cases, as well as Verizon's counterclaim. In February 2020, Huawei sued Verizon, accusing the company of unauthorized use of more than a dozen Huawei patents in computer networks, download security, and video communications, seeking damages and royalties. In response to today's settlement, Huawei said in a statement: "We are pleased that the two companies have reached a settlement that ends their patent litigation. The terms of the agreement are confidential." People familiar with the matter said huawei's claims could exceed $1 billion. Huawei also noted that it has "more than 100,000 patents in force worldwide, including approximately 10,000 in the United States." Verizon has yet to comment, but said last year that the lawsuits were little more than a public relations stunt. In addition, Verizon has countersued Huawei for patent infringement. "We simply ask Verizon to respect Huawei's investment in research and development and either pay for the use of our patents or refrain from using them," Huawei said last year. Since 2015, huawei won the intellectual property rights of income accumulative total more than $1.4 billion, history accumulated more than 6 billion dollars to pay royalties for legitimate use other company's patent, with 80% paid to American companies. Only high investment can bring high return. The technology that leads the world is huawei's money. Billions and billions of research and development of a technology, with what provided free of charge to each other. So the royalty fees charged by huawei won't give up, how many patent verizon specific to huawei is unknown, but can be seen from the attitude of tough royalties huawei, technology is the absolute principle. With technology, we can promote the development of science and technology, and with technology, we are not afraid of intransigence. Huawei will insist on research and development, more technical breakthrough, form a larger system of patented technology.
Kerendia Receives FDA Approval for Slowing chronic kidney disease in Type 2 Diabetes [ 2021-07-15 ]
Kerendia Receives FDA Approval for Slowing chronic kidney disease in Type 2 Diabetes This month FDA announced that they have approved Kerendia (finerenone) tablets for the treatment of patients with chronic kidney disease associated with type 2 diabetes. Kerendia is indicated to delay chronic kidney disease progression. It is able to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adult diabetic patients. Now the drug has also been submitted for marketing authorization in China, European Union and other countries. There are 422 million people with diabetes, and there are up to 40% of all patients with type 2 diabetes develop chronic kidney disease. Diabetes is one of the most common causes of chronic kidney disease and kidney failure. Chronic kidney disease is the gradual loss of kidney function over a period of months to years. It occurs when the kidneys are damaged and cannot filter blood normally, and sometimes can progress to kidney failure. The patients are also at high risk of heart disease because of defective filtering. Kerendia is the first and only nonsteroidal mineralocorticoid receptor antagonist (MRA) for Type 2 diabetic patients with chronic kidney disease, compared to SGLT2 inhibitors, Farxiga (dapagliflozin) and Invokana (canagliflozin). It blocks overactivation of the mineralocorticoid receptor (MR) which contributes to fibrosis and inflammation. The drug is able to target fibrosis and inflammation to slow kidney disease progression. The efficacy of Kerendia was evaluated in a randomized, multicenter, double-blind, placebo-controlled in the phase III trial. There were 5,674 patients in the study. The study found that Kerendia beat placebo when it came to kidney function. That included fending off or slowing progression to kidney failure and kidney death. Furthermore, the study also found that Kerendia reduced the risk of cardiovascular death, non-fatal heart attack, and hospitalization for heart failure.   Kerendia received priority review and fast track designations for their application, and it will be commercially available in the U.S. by the end of July.   資料來源： https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-drug-reduce-risk-serious-kidney-and-heart-complications-adults-chronic-kidney-disease https://www.pharmalive.com/bayers-kerendia-receives-u-s-fda-approval/ https://finance.yahoo.com/news/bayers-kerendia-scores-long-awaited-111105329.html https://www.businesswire.com/news/home/20210709005441/en/Bayer%E2%80%99s-KERENDIA%C2%AE-finerenone-Receives-U.S.-FDA-Approval-for-Treatment-of-Patients-with-Chronic-Kidney-Disease-Associated-with-Type-2-Diabetes https://www.healio.com/news/endocrinology/20200710/finerenone-delays-diabetic-kidney-disease-progression-fideliodkd  
FDA approves the first C3 inhibitor for adults with serious rare blood disease [ 2021-05-21 ]
FDA approves the first C3 inhibitor for adults with serious rare blood disease On May 14th, 2021, Apellis Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new injection treatment, EMPAVELI™ (pegcetacoplan), for adults with paroxysmal nocturnal hemoglobinuria (PNH). It is the first and only PNH medication that targets C3, the central protein in the complement system. Paroxysmal nocturnal hemoglobinuria, PNH in short, is a rare, acquired, life-threatening blood disorder. The key features of the disease are red blood cell destruction, blood clots, and impaired bone marrow function. PNH results from gene mutations that affect red blood cells. Patients with mutated PIGA on the X chromosome have abnormal hematopoietic stem cells which produce defective red blood cells. The destructive blood cells can be detected and destroyed by the immune system, which results in hemolytic anemia, or other symptoms, such as red discoloration of the urine. The prevalence rate is about 1 to 1.5 people per million. Individuals are typically diagnosed around ages 35 to 40, and the PNH patients have an average survival of 8-15 years after diagnosis. Nevertheless, around 25% of the patients may live more than 25 years with only minor symptoms. As the first and FDA-approved targeted C3 therapy, EMPAVELI (pegcetacoplan) has better effectiveness than C5 inhibitors. It can treat PNH adults who have never undergone PNH treatment or the patients who previously took C5 inhibitors, Soliris® (eculizumab), or Ultomiris® (ravulizumab). The approval of Empaveli was based on data from a multi-center, randomized, head-to-head Phase III study (ClinicalTrials.gov: NCT03500549) which compared the efficacy and safety of Empaveli to Soliris in 80 adults with PNH. The patients were divided into two groups which were randomly assigned to received either Empaveli 1,080 mg/20mL twice weekly or their current dose of Soliris for 16 weeks. The severity of anemia was compared in the two treatment groups which had the average 8.7 g/dL hemoglobin at baseline. Normal hemoglobin values in adult men and women are more than 14 g/dL and 12 g/dL respectively. After the 16-week treatment, patients in the Empaveli group averagely increased 2.4 g/dL of their hemoglobin. Meanwhile, patients in the Soliris group averagely decreased 1.5 g/dL of their hemoglobin. Moreover, 85% of the Empaveli -treated patients were transfusion free compared to 15% of the Soliris-treated patients over 16 weeks. Empaveli is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (Empaveli REMS; https://empavelirems.com/#Main) due to the risk of serious infections. In addition, the most common side effects are injection site reactions, viral/ microbial infections, diarrhea, abdominal pain, respiratory tract infection, and fatigue. It must be said that Empaveli is a significant milestone that boosts the development of C3 therapies for rare diseases. The approval of EMPAVELI not only gives more treatment options of PNH but also brings new promise for the PNH community.
Hengrui Medicine's application for the listing of CDK4/6 inhibitors has been accepted [ 2021-04-29 ]
Hengrui Medicine's application for the listing of CDK4/6 inhibitors has been accepted On April 27, the Center for Drug Evaluation (CDE) announced that the new drug listing application submitted by Hengrui Medicine's Class 1 new drug CDK 4/6 (cyclin-dependent kinase 4 and 6)inhibitor SHR6390 tablets has been accepted, and the indication is: combined with Fulvestrant for hormone receptor (HR) positive and treatment of recurrent or metastatic breast cancer that is negative for human epidermal growth factor receptor 2 (HER2) after endocrine therapy. Breast cancer is the most common cancer among women worldwide. The most common subtype is the HR positive/HER2 negative subtype, which accounts for 70% of the total number of Breast cancer patients. Approximately 30% of patients diagnosed with HR-positive and HER2-negative early breast cancer are still at risk of cancer recurrence. At present, the combination therapy of CDK 4/6 inhibitors and endocrine drugs has become a new model for reversing the resistance of endocrine therapy, significantly improving the prognosis of patients with HR-positive advanced Breast cancer. CDK 4/6 is a key regulator that drives cell division. Studies have found that CDK 4/6 is overexpressed in many cancer cells, leading to uncontrolled cell division cycles and unlimited proliferation. Clinical studies have confirmed that more than half of breast cancer patients overexpress cyclin D (cyclin D), and most of them are HR-positive breast cancer patients. Because cyclin D directly acts on CDK 4/6, CDK 4/6 has become an important molecular target for patients with HR-positive metastatic breast cancer. SHR6390 is an oral, high-efficiency and selective small molecule CDK 4/6 inhibitor developed by Hengrui Medicine, which is a Class 1 new drug. It can selectively inhibit CDK 4/6 kinase activity, thereby blocking the CDK 4/6-retinoblastoma protein (Rb) signaling pathway, thereby inducing tumor cell G1 blockade, and selectively inhibiting the high expression of Rb Of tumor cells proliferate. Therefore, SHR6390 plays a decisive role in blocking the process of cells from G1 phase to S phase, thereby effectively inhibiting tumor cell proliferation, achieving the effect of anti-tumor and prolonging the survival of patients. Public information shows that SHR6390 has reached the pre-designated superiority standard in a multi-center, randomized, controlled, double-blind phase 3 clinical study named SHR6390-III-301. Compared with placebo and fulvestrant, it accepts SHR6390 combined with Fulvestrant can significantly prolong the progression-free survival of patients. The arrival of Hengrui Medicine SHR6390 is expected to bring new treatment options for breast cancer patients.  
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