YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 351 drug applications between 5 March 2026 and 11 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 33, covering 26 drug names.

2026/03/05 – 2026/03/11

Period
2026/03/05 to 2026/03/11, 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
351
Drugs with new generic filings (by drug name, de-duplicated)
26
Accepted this week, now under review
99

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

351filings, 33 of them generic

By application type

Application typeFilings
Supplement221
New drug65
Generic33
Import15
Unspecified9
Import re-registration8

By drug type

Drug typeFilings
Chemical drug171
TCM97
Therapeutic biologic71
Biologic6
Prophylactic biologic6

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

26 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Cetitizine Hydrochloride Oral Solution316
2Polyvinyl Alcohol Eye Drops2224
3Tacrolimus Capsules212
4Sacubitril Valsartan Sodium Tablets2170
5磷苯妥英钠注射用浓溶液 · No verified English name216
6Acetate And Glucose Electrolytes Injection214
7Acetylcysteine Injection1153
8Acetylcysteine Tablets118
9Sodium Lactate Ringer's Irrigation Solution115
10二甲双胍恩格列净片(I) · No verified English name112

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

193 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bayer Vital GmbH1610
2Hong Ji Tang Pharmaceutical (Lai Wu Qu) Co., Ltd. romanized14110
3Hubei Ji An Tang Pharma Co., Ltd. romanized12120
4Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized1210
5Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized920
6Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized640
7Janssen Research & Development LLC630
8Qilu Pharmaceutical Co., Ltd.540
9Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized440
10Eli Lilly and Company420

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

94 this week

AcceptedDrugApplicants
2026/03/11Import · Class 1 LY4005130注射液 · No verified English nameJXSL2600076 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/11Import · Class 1 RO7589655注射液 · No verified English nameJXSL2600073 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/03/11Import · Class 1 RO7589655注射液 · No verified English nameJXSL2600072 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/03/11Import · Class 1 RO7589655注射液 · No verified English nameJXSL2600071 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/03/11Import · Class 1 RO7589655注射液 · No verified English nameJXSL2600070 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/03/11Import · Class 1 LY4005130注射液 · No verified English nameJXSL2600069 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2026/03/11Import · Class 2.4 Adagrasib 片 · No verified English nameJXHL2600080 Mirati Therapeutics Inc. a Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd
2026/03/11Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2600644 Hunan Chun Jian Pharmaceutical Technology Co., Ltd. romanized; Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized
2026/03/11Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2600640 Guizhou Qian Yao Group Pharmaceutical Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2026/03/11New drug · Class 2.2 卡度尼利单抗注射液 · No verified English nameCXSL2600322 Kang Fang Pharma Co., Ltd. romanized
2026/03/11New drug · Class 1 注射用BGB-B2033 · No verified English nameCXSL2600321 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2026/03/11New drug · Class 1 IBI3005 · No verified English nameCXSL2600320 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/03/11New drug · Class 3.2 新型佐剂流感病毒裂解疫苗 · No verified English nameCXSL2600319 Hua Lan Bio Yi Miao Co., Ltd. romanized
2026/03/11New drug · Class 1 IBI3014 · No verified English nameCXSL2600318 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/03/11New drug · Class 3.3 人生长激素注射液 · No verified English nameCXSL2600317 Jun He Meng Biopharmaceutical (Hangzhou) Co., Ltd. romanized
2026/03/11New drug · Class 1 硫酸益母草碱片 · No verified English nameCXHL2600295 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized
2026/03/11New drug · Class 1 硫酸益母草碱片 · No verified English nameCXHL2600294 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized
2026/03/11New drug · Class 1 硫酸益母草碱片 · No verified English nameCXHL2600293 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized
2026/03/11New drug · Class 1 硫酸益母草碱片 · No verified English nameCXHL2600292 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized
2026/03/11New drug · Class 2.4 L-5-甲基四氢叶酸钙片 · No verified English nameCXHL2600291 Beijing Si Li An Pharma Co., Ltd. romanized
2026/03/11New drug · Class 1 APG-5918片 · No verified English nameCXHL2600290 Suzhou Ya Sheng Pharma Co., Ltd. romanized; Guangzhou Shun Jian Biopharmaceuticals Technology Co., Ltd. romanized
2026/03/11New drug · Class 1 APG-5918片 · No verified English nameCXHL2600289 Suzhou Ya Sheng Pharma Co., Ltd. romanized; Guangzhou Shun Jian Biopharmaceuticals Technology Co., Ltd. romanized
2026/03/11New drug · Class 1 CB03-154片 · No verified English nameCXHL2600288 Shanghai Zhi Meng Pharmaceuticals Technology Co., Ltd. romanized
2026/03/11New drug · Class 2.2 E562 · No verified English nameCXHL2600287 Guangdong Hong Shan Hu Pharma Co., Ltd. romanized
2026/03/11New drug · Class 1 HL-400缓释片 · No verified English nameCXHL2600286 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2026/03/11New drug · Class 1 HL-400缓释片 · No verified English nameCXHL2600285 Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized
2026/03/10Import · Class 1 JNJ-87189401 注射液 (皮下注射) · No verified English nameJXSL2600075 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/03/10Import · Class 1 JNJ-87189401 注射液 (皮下注射) · No verified English nameJXSL2600074 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2026/03/10Generic · Class 3 Sodium Lactate Ringer's Irrigation SolutionCYHS2600637 Shandong Hua Mao Pharma Co., Ltd. romanized
2026/03/10Generic · Class 3 Dexketoprofen Trometamol InjectionCYHL2600033 SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED

64 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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