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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 565 drug applications between 6 May 2026 and 12 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 52 drug names.

2026/05/06 – 2026/05/12

Period
2026/05/06 to 2026/05/12, 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
565
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
128

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

565filings, 69 of them generic

By application type

Application typeFilings
Supplement322
New drug103
Generic69
Import40
Unspecified22
Import re-registration9

By drug type

Drug typeFilings
Chemical drug255
TCM201
Therapeutic biologic89
Biologic17
Prophylactic biologic3

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

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dotinurad Tablets4255
2Galanthamine Hydrobromide Oral Solution315
3瑞维那新吸入溶液 · No verified English name2253
4Sitagliptin and Metformin Hydrochloride Extended-release Tablets2212
5Lidocaine and Tetracaine Cream212
6Piracetam Injection219
7Tolvaptan Orally Disintegrating Tablets215
8Nafamostat Mesilate for Injection2138
9甲磺酸帕珠沙星氯化钠注射液 · No verified English name212
10Trazodone Hydrochloride Sustained-release Tablets2120

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

321 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB2130
2Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized17150
3Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized1280
4Qilu Pharmaceutical Co., Ltd.941
5Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized660
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
7Novo Nordisk A/S550
8Bao Guang Pharma (Chengdu) Co., Ltd. romanized550
9Qinghai Di Ma Er Zang Yao Pharma Co., Ltd. romanized550
10Pfizer Inc.540

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

161 this week

AcceptedDrugApplicants
2026/05/12Import · Class 1 Sorfequiline片 · No verified English nameJXHL2600163 The Global Alliance for TB Drug Development Inc.; Global Health Innovation Institute
2026/05/12Generic · Class 3 Sodium Thiosulfate InjectionCYHS2601085 Zhongguo Da Zhong Pharmaceutical Co., Ltd. romanized
2026/05/12Generic · Class 3 Vitamin K1 InjectionCYHS2601084 Chongqing Lai Mei Pharma Co., Ltd. romanized; Nanjing Chen Gong Pharmaceutical Co., Ltd. romanized
2026/05/12Generic · Class 3 甲磺酸帕珠沙星氯化钠注射液 · No verified English nameCYHS2601083 HUNAN WARRANT PHARMACEUTICAL CO.,LTD; Hunan Kang Yuan Pharmaceutical Co., Ltd. romanized
2026/05/12Generic · Class 3 甲磺酸帕珠沙星氯化钠注射液 · No verified English nameCYHS2601082 HUNAN WARRANT PHARMACEUTICAL CO.,LTD; Hunan Kang Yuan Pharmaceutical Co., Ltd. romanized
2026/05/12Generic · Class 3 Tolvaptan Orally Disintegrating TabletsCYHS2601080 Jiangxi Shimei Pharmaceutical Co., Ltd
2026/05/12Generic · Class 3 Emedastine Difumarate Sustained-release CapsulesCYHS2601079 Hainan Mei Kang Da Pharma Co., Ltd. romanized; Sichuan De Feng Pharma Co., Ltd. romanized
2026/05/12Generic · Class 3 Tolvaptan Orally Disintegrating TabletsCYHS2601078 Jiangxi Shimei Pharmaceutical Co., Ltd
2026/05/12Generic · Class 3 Galanthamine Hydrobromide Oral SolutionCYHS2601077 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2026/05/12Generic · Class 3 Galanthamine Hydrobromide Oral SolutionCYHS2601076 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2026/05/12Generic · Class 3 Galanthamine Hydrobromide Oral SolutionCYHS2601075 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2026/05/12Generic · Class 3 托吡酯口服溶液 · No verified English nameCYHS2601069 Guo Yao Rui Fu Lai Pharma Co., Ltd. romanized; Hubei Duo Rui Pharma Co., Ltd. romanized
2026/05/12New drug · Class 3.1 桃红四物汤颗粒 · No verified English nameCXZS2600026 Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized
2026/05/12New drug · Class 2.3 麝香通心滴丸 · No verified English nameCXZL2600042 Nei Menggu Kang En Bei Pharma Co., Ltd. romanized
2026/05/12New drug · Class 1 SPY002-091, 200 mg/mL IV · No verified English nameCXSL2600506 Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/05/12New drug · Class 1 SPY002-091, 200 mg/mL SC · No verified English nameCXSL2600505 Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/05/12New drug · Class 2.4 SPY003-207, 180 mg/mL SC · No verified English nameCXSL2600504 Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/05/12New drug · Class 2.4 SPY003-207, 150 mg/mL IV · No verified English nameCXSL2600503 Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/05/12New drug · Class 2.4 SPY001-001, 180 mg/mL SC · No verified English nameCXSL2600502 Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/05/12New drug · Class 2.4 SPY001-001, 150mg/mL IV · No verified English nameCXSL2600501 Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/05/12New drug · Class 2.2 酪酸梭菌活菌滴剂(胶囊型) · No verified English nameCXSL2600500 Hangzhou Yuan Da Biopharmaceutical Co., Ltd. romanized
2026/05/12New drug · Class 1 注射用 B024 · No verified English nameCXSL2600499 Shanghai Shang Yao Jiao Lian Pharmaceuticals Technology Co., Ltd. romanized
2026/05/12New drug · Class 2.2 注射用重组人尿激酶原 · No verified English nameCXSL2600498 Tian Shi Li Biopharmaceuticals Co., Ltd. romanized
2026/05/12New drug · Class 1 CT0596 CAR T细胞注射液 · No verified English nameCXSL2600497 You Kai Ze Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2026/05/12New drug · Class 1 IxCell hUC-MSC-P注射液 · No verified English nameCXSL2600496 Shanghai Ai Sa Er Biopharmaceuticals Co., Ltd. romanized
2026/05/12New drug · Class 1 注射用ALK201 · No verified English nameCXSL2600495 Shanghai An Ling Ke Biopharmaceuticals Co., Ltd. romanized
2026/05/12New drug · Class 1 9MW5211注射液 · No verified English nameCXSL2600494 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2026/05/12New drug · Class 2.2 依沃西单抗注射液 · No verified English nameCXSL2600493 Kang Fang Sai Nuo Pharmaceuticals Co., Ltd. romanized
2026/05/12New drug · Class 1 JSKN033注射液 · No verified English nameCXSL2600492 Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2026/05/12New drug · Class 1 GFS202A注射液 · No verified English nameCXSL2600491 Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized

131 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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