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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 458 drug applications between 2 September 2026 and 8 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 66, covering 53 drug names.

2026/09/02 – 2026/09/08

Period
2026/09/02 to 2026/09/08, 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
458
Drugs with new generic filings (by drug name, de-duplicated)
53
Accepted this week, now under review
378

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

458filings, 66 of them generic

By application type

Application typeFilings
Supplement261
New drug85
Generic66
Import29
Import re-registration13
Unspecified4

By drug type

Drug typeFilings
Chemical drug202
TCM163
Therapeutic biologic90
Prophylactic biologic2
In vitro diagnostic reagent1

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

53 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Adapalene And Benzoyl Peroxide Gel3230
2富马酸奥赛利定注射液 · No verified English name313
3Lactulose Oral Solution2134
4Dotinurad Tablets2155
5Ticagrelor Tablets2110
6Rosuvastatin Calcium Tablets2118
7Trazodone Hydrochloride Sustained-release Tablets2120
8Fexofenadine Hydrochloride Tablets2110
9Sodium Bicarbonate Injection2110
10Minoxidil Liniment2152

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

267 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized13130
2Changchun Jin Sai Pharma Co., Ltd. romanized820
3AbbVie Inc.810
4Beijing Kang Nuo Ya Biopharmaceuticals Co., Ltd. romanized810
5Gan Li Pharma Shandong Co., Ltd. romanized810
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
7Beijing Kang Di Ni Pharma Co., Ltd. romanized550
8Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized540
9Pfizer Inc.530
10Novartis Pharma AG440

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

140 this week

AcceptedDrugApplicants
2026/09/08Import · Class 1 BH-30643片 · No verified English nameJXHL2600399 BlossomHill Therapeutics Inc.; Caidya Biopharmaceutical Co. Ltd.
2026/09/08Import · Class 1 BH-30643片 · No verified English nameJXHL2600398 BlossomHill Therapeutics Inc.; Caidya Biopharmaceutical Co. Ltd.
2026/09/08Generic · Class 3 坎地沙坦酯氢氯噻嗪片(Ⅰ) · No verified English nameCYHS2602244 Anhui Jia He Pharma Co., Ltd. romanized
2026/09/08Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide Tablets(II)CYHS2602243 Anhui Jia He Pharma Co., Ltd. romanized
2026/09/08Generic · Class 3 富马酸奥赛利定注射液 · No verified English nameCYHS2602242 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2026/09/08Generic · Class 3 富马酸奥赛利定注射液 · No verified English nameCYHS2602241 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2026/09/08Generic · Class 3 富马酸奥赛利定注射液 · No verified English nameCYHS2602240 Chengdu Easton Biopharmaceuticals Co.,Ltd.
2026/09/08Generic · Class 3 腹膜透析液(碳酸氢盐-G2.5%) · No verified English nameCYHS2602238 Anhui Feng Yuan Pharma Co., Ltd. romanized
2026/09/08Generic · Class 3 腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2602237 Anhui Feng Yuan Pharma Co., Ltd. romanized
2026/09/08Generic · Class 3 Sodium Bicarbonate InjectionCYHS2602234 Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized
2026/09/08Generic · Class 3 Sodium Bicarbonate InjectionCYHS2602233 Jiao Zuo Shi Min Kang Pharma Co., Ltd. romanized
2026/09/08New drug · Class 1.1 开心散加味颗粒 · No verified English nameCXZL2600089 Qingdao Yi Sheng Kang He Bio Technology Co., Ltd. romanized
2026/09/08New drug · Class 1.2 YN17 · No verified English nameCXZL2600088 Zhejiang Yong Ning Pharma Co., Ltd. romanized
2026/09/08New drug · Class 1.2 注射用YN17 · No verified English nameCXZL2600087 Zhejiang Yong Ning Pharma Co., Ltd. romanized
2026/09/08New drug · Class 1 SYS6088注射液 · No verified English nameCXSL2600977 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/09/08New drug · Class 1 SENL103自体T细胞注射液 · No verified English nameCXSL2600976 Hebei Sen Lang Bio Technology Co., Ltd. romanized
2026/09/08New drug · Class 1 SENL103自体T细胞注射液 · No verified English nameCXSL2600975 Hebei Sen Lang Bio Technology Co., Ltd. romanized
2026/09/08New drug · Class 1 注射用IMD1005 · No verified English nameCXSL2600974 Shanghai Ying Mai De Medical Technology Co., Ltd. romanized
2026/09/08New drug · Class 1 SHR-4375注射液 · No verified English nameCXSL2600973 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/09/08New drug · Class 1 JV101注射液 · No verified English nameCXSL2600972 Shanghai Yu Fang Biopharmaceuticals Technology Co., Ltd. romanized
2026/09/08New drug · Class 1 HDM4002注射液 · No verified English nameCXSL2600971 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2026/09/08New drug · Class 1 注射用SIM0505 · No verified English nameCXSL2600970 Shanghai Xian Sheng Zai Ming Pharmaceuticals Bio Technology Co., Ltd. romanized
2026/09/08New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2600969 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/09/08New drug · Class 1 SHR-4610注射液 · No verified English nameCXSL2600968 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/09/08New drug · Class 2.2 罗赛促红素α注射液 · No verified English nameCXSL2600967 Guangdong San Sheng Pharmaceutical Co., Ltd. romanized
2026/09/08New drug · Class 2.4 泽布替尼胶囊 · No verified English nameCXHS2600127 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/09/08New drug · Class 1 HX9428片 · No verified English nameCXHL2601091 Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized
2026/09/08New drug · Class 1 HX9428片 · No verified English nameCXHL2601090 Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized
2026/09/08New drug · Class 1 TAN-118乳膏 · No verified English nameCXHL2601089 Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized
2026/09/08New drug · Class 1 TAN-118乳膏 · No verified English nameCXHL2601088 Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized

110 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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