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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 433 drug applications between 3 September 2026 and 9 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 62, covering 50 drug names.

2026/09/03 – 2026/09/09

Period
2026/09/03 to 2026/09/09, 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
433
Drugs with new generic filings (by drug name, de-duplicated)
50
Accepted this week, now under review
352

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

433filings, 62 of them generic

By application type

Application typeFilings
Supplement261
New drug84
Generic62
Import16
Import re-registration7
Unspecified3

By drug type

Drug typeFilings
Chemical drug192
TCM157
Therapeutic biologic81
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

50 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sodium Bicarbonate Injection3210
2Adapalene And Benzoyl Peroxide Gel3230
3富马酸奥赛利定注射液 · No verified English name313
4Dotinurad Tablets2155
5Ticagrelor Tablets2110
6Ambroxol Hydrochloride Oral Solution2146
7Fexofenadine Hydrochloride Tablets2110
8Minoxidil Liniment2152
9Mirogabalin Besilate Tablets2161
10Pemafibrate Tablets1123

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

257 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
3Beijing Kang Nuo Ya Biopharmaceuticals Co., Ltd. romanized810
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
5Shenzhen Han Yu Pharma Co., Ltd. romanized610
6Henan Bai Nian Kang Xin Pharma Co., Ltd. romanized550
7Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized540
8Novartis Pharma AG440
9Jilin Yu Ren Pharmaceutical Co., Ltd. romanized440
10Jilin Bai Qi 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

127 this week

AcceptedDrugApplicants
2026/09/09Generic · Class 3 Sodium Bicarbonate InjectionCYHS2602252 Shanxi Cheng Ze Yuan Bio Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized
2026/09/09Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2602251 Shandong Nuo He Kang Pharma Co., Ltd. romanized
2026/09/09Generic · Class 3 Triamcinolone Acetonide and Econazole Nitrate CreamCYHS2602250 Jiangsu Hua Han Pharmaceuticals Technology Co., Ltd. romanized; TC Pharmaceuticals (Jiangsu) Co., Ltd
2026/09/09New drug · Class 1 注射用SAL02681 · No verified English nameCXSL2600984 Nanjing Sai Le Si Biopharmaceutical Co., Ltd. romanized
2026/09/09New drug · Class 1 UGX202注射液 · No verified English nameCXSL2600983 Suzhou Xing Ming You Jian Bio Technology Co., Ltd. romanized
2026/09/09New drug · Class 1 注射用SAL02682 · No verified English nameCXSL2600982 Nanjing Sai Le Si Biopharmaceutical Co., Ltd. romanized
2026/09/09New drug · Class 1 SQ-25042眼内注射溶液 · No verified English nameCXSL2600981 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2026/09/09New drug · Class 1 SQ-25042眼内注射溶液 · No verified English nameCXSL2600980 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2026/09/09New drug · Class 1 SQ-25042眼内注射溶液 · No verified English nameCXSL2600979 Shenyang Xing Qi Yan Yao Co., Ltd. romanized
2026/09/09New drug · Class 1 异体3D间充质基质细胞注射液 · No verified English nameCXSL2600978 Jian Yuan (Beijing) Zai Sheng Yi Xue Technology Co., Ltd. romanized; Zhang Jia Kou Jian Yuan Jing Zhun Yi Xue Co., Ltd. romanized
2026/09/09New drug · Class 1 瑞普泊肽注射液 · No verified English nameCXHS2600129 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/09/09New drug · Class 1 瑞普泊肽注射液 · No verified English nameCXHS2600128 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/09/09New drug · Class 1 注射用GGA-sNIR · No verified English nameCXHL2601104 Guangzhou Shi Yun Bio Technology Co., Ltd. romanized
2026/09/09New drug · Class 1 ZL-65片 · No verified English nameCXHL2601103 Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized
2026/09/09New drug · Class 1 ZL-65片 · No verified English nameCXHL2601102 Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized
2026/09/09New drug · Class 1 ZL-65片 · No verified English nameCXHL2601101 Chengdu Ze Ling Biopharmaceuticals Technology Co., Ltd. romanized
2026/09/09New drug · Class 1 HY3003注射液 · No verified English nameCXHL2601100 Shenzhen Han Yu Pharma Co., Ltd. romanized
2026/09/09New drug · Class 1 HY3003注射液 · No verified English nameCXHL2601099 Shenzhen Han Yu Pharma Co., Ltd. romanized
2026/09/09New drug · Class 1 HY3003注射液 · No verified English nameCXHL2601098 Shenzhen Han Yu Pharma Co., Ltd. romanized
2026/09/09New drug · Class 1 HY3003注射液 · No verified English nameCXHL2601097 Shenzhen Han Yu Pharma Co., Ltd. romanized
2026/09/09New drug · Class 1 HY3003注射液 · No verified English nameCXHL2601096 Shenzhen Han Yu Pharma Co., Ltd. romanized
2026/09/09New drug · Class 1 HY3003注射液 · No verified English nameCXHL2601095 Shenzhen Han Yu Pharma Co., Ltd. romanized
2026/09/09New drug · Class 1 YKYY036注射液 · No verified English nameCXHL2601094 Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Yue Kang Pharma Group Hangzhou Tian Long Pharma Co., Ltd. romanized
2026/09/09New drug · Class 1 GPN01564雾化吸入剂 · No verified English nameCXHL2601093 Yuan Da Pharmaceuticals Technology (Wuhan) Co., Ltd. romanized; Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized
2026/09/09New drug · Class 1 SV-1993注射液 · No verified English nameCXHL2601092 Beijing Sen Miao Bio Technology Co., Ltd. romanized
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.

97 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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