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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 418 drug applications between 11 July 2026 and 17 July 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 47 drug names.

2026/07/11 – 2026/07/17

Period
2026/07/11 to 2026/07/17, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
418
Drugs with new generic filings (by drug name, de-duplicated)
47
Accepted this week, now under review
136

DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.

Names with a public page are linked.

New acceptances this week

By application type and drug type

418filings, 65 of them generic

By application type

Application typeFilings
Supplement251
Generic65
New drug57
Import26
Unspecified14
Import re-registration5

By drug type

Drug typeFilings
Chemical drug210
TCM130
Therapeutic biologic67
Prophylactic biologic7
Biologic4

DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.

Most new generic filings, by drug

47 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ethyl Iosapentate Capsules3227
2Dotinurad Tablets3155
3Brivaracetam Tablets3119
4瑞维那新吸入溶液 · No verified English name2253
5Buprenorphine Transdermal Patches216
6Gatifloxacin Eye Drops213
7Oxaliplatin Injection214
8Baricitinib Tablets2132
9Cefuroxime Sodium for Injection218
10甲苯磺酸卢美哌隆胶囊 · No verified English name212

DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.

Most new acceptances, by company

260 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Pfizer Inc.1020
2An Kang Zheng Da Pharmaceutical Co., Ltd. romanized650
3Les Laboratoires Servier640
4Amgen Inc.610
5Hangzhou Bai Xin Biopharmaceuticals Technology Co., Ltd. romanized610
6Shanxi Huang He Zhong Yao Co., Ltd. romanized550
7Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized550
8Novo Nordisk A/S520
9Beijing Xian Sheng Xiang Rui Bio Zhi Pin Co., Ltd. romanized520
10Nanjing Tong Ren Tang Pharma Co., Ltd. romanized440

DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.

Under-review list changes

Compared across this platform's snapshots of the under-review list

Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.

DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.

Class 3 and new-drug acceptances

110 this week

AcceptedDrugApplicants
2026/07/17Import · Class 1 Afimkibart注射液 · No verified English nameJXSL2600171 F. Hoffmann-La Roche Ltd.
2026/07/17Import · Class 1 Afimkibart注射液 · No verified English nameJXSL2600170 F. Hoffmann-La Roche Ltd.
2026/07/17Import · Class 2.4 塞普替尼胶囊 · No verified English nameJXHS2600077 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd
2026/07/17Import · Class 2.4 塞普替尼胶囊 · No verified English nameJXHS2600076 Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd
2026/07/17Generic · Class 3 Bilastine Oral SolutionCYHS2601719 Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/07/17Generic · Class 3 Dexmedetomidine Hydrochloride InjectionCYHS2601718 Kang Nuo Biopharmaceutical Co., Ltd. romanized
2026/07/17Generic · Class 3 Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2601714 ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2026/07/17Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601711 Fujian Da Pu Biopharmaceuticals Co., Ltd. romanized; Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized
2026/07/17Generic · Class 3 Gatifloxacin Eye DropsCYHS2601710 Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2026/07/17Generic · Class 3 Gatifloxacin Eye DropsCYHS2601709 Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2026/07/17New drug · Class 2.3 季德胜蛇药片 · No verified English nameCXZL2600062 Jing Hua Pharmaceutical Group Co., Ltd. romanized
2026/07/17New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2600745 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/07/17New drug · Class 1 注射用LM-2417 · No verified English nameCXSL2600744 Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/07/17New drug · Class 1 HX15001注射液 · No verified English nameCXSL2600743 Hua Shen Zhi Yao Bio Technology (Suzhou) Co., Ltd. romanized
2026/07/17New drug · Class 1 SCTB41注射液 · No verified English nameCXSL2600742 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/07/17New drug · Class 3.3 达雷妥尤单抗注射液(皮下注射) · No verified English nameCXSL2600741 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/07/17New drug · Class 2.4 妥拉美替尼胶囊 · No verified English nameCXHL2600869 Shanghai Ke Zhou Drug Co., Ltd. romanized
2026/07/17New drug · Class 1 RCZY690片 · No verified English nameCXHL2600868 Yan Tai Rong Chang Pharmaceutical Co., Ltd. romanized
2026/07/17New drug · Class 1 RCZY690片 · No verified English nameCXHL2600867 Yan Tai Rong Chang Pharmaceutical Co., Ltd. romanized
2026/07/17New drug · Class 1 DIP-1018胶囊 · No verified English nameCXHL2600866 Zhejiang University romanized; Zhejiang University Jin Hua Research Institute romanized; Name not romanized; Ao Rui Te Pharma Co., Ltd. romanized
2026/07/17New drug · Class 1 DIP-1018胶囊 · No verified English nameCXHL2600865 Zhejiang University romanized; Zhejiang University Jin Hua Research Institute romanized; Name not romanized; Ao Rui Te Pharma Co., Ltd. romanized
2026/07/16Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600169 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/07/16Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600168 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/07/16Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600167 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/07/16Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600166 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/07/16Generic · Class 3 苯磺酸氨氯地平口服溶液 · No verified English nameCYHS2601703 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Hefei Cheng Zhi Biopharmaceutical Co., Ltd. romanized
2026/07/16Generic · Class 3 Brivaracetam TabletsCYHS2601699 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2026/07/16Generic · Class 3 Brivaracetam TabletsCYHS2601698 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2026/07/16Generic · Class 3 Brivaracetam TabletsCYHS2601697 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2026/07/16New drug · Class 3.3 精蛋白锌重组赖脯胰岛素混合注射液(25R) · No verified English nameCXSS2600108 Tong Hua Dong Bao Pharma Co., Ltd. romanized

80 more not listed (at most 30 rows).

DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.

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