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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 358 drug applications between 6 December 2025 and 12 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 81, covering 59 drug names.

2025/12/06 – 2025/12/12

Period
2025/12/06 to 2025/12/12, 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
358
Drugs with new generic filings (by drug name, de-duplicated)
59
Accepted this week, now under review
112

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

358filings, 81 of them generic

By application type

Application typeFilings
Supplement143
New drug96
Generic81
Import re-registration17
Unspecified16
Import5

By drug type

Drug typeFilings
Chemical drug220
TCM69
Therapeutic biologic47
Biologic12
Prophylactic biologic6
In vitro diagnostic reagent4

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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution5334
2Minoxidil Liniment4252
3Norepinephrine Bitartrate Injection329
4Finerenone Tablets3269
5Metformin Hydrochloride And Empagliflozin Extended Release Tablets3112
6Pregabalin Capsules3112
7Emedastine Difumarate Eye Drops229
8复方醋酸钠葡萄糖注射液 · No verified English name218
9多种微量元素注射液(IV) · No verified English name214
10左羟丙哌嗪糖浆 · No verified English name210

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

224 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fresenius Kabi Austria GmbH610
2Biao Xin Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized610
3Gansu Tian Shui Qi Huang Pharma Co., Ltd. romanized550
4Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized530
5Bayer AG520
6Terumo Corporation Kofu Factory510
7Shi Yao Group Bai Ke (Shandong) Biopharmaceutical Co., Ltd. romanized510
8Shanghai Ke Hua Bio Gong Cheng Co., Ltd. romanized440
9Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized440
10Ha Yao Group Shi Yi Tang Pharmaceutical Factory 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

133 this week

AcceptedDrugApplicants
2025/12/12Generic · Class 3 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2504267 Jiangsu Huai An Shuang He Pharma Co., Ltd. romanized
2025/12/12Generic · Class 3 复方醋酸钠葡萄糖注射液 · No verified English nameCYHS2504266 Jiangsu Huai An Shuang He Pharma Co., Ltd. romanized
2025/12/12Generic · Class 3 Indocyaninegreen for InjectionCYHS2504265 Zhejiang Hang Kang Pharma Co., Ltd. romanized
2025/12/12Generic · Class 3 硝苯地平缓释片(Ⅱ) · No verified English nameCYHS2504263 Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized
2025/12/12New drug · Class 2.2 斯鲁利单抗注射液 · No verified English nameCXSS2500141 Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2025/12/12New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2501076 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/12/12New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2501075 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/12/12New drug · Class 1 SM17单克隆抗体注射液(皮下注射) · No verified English nameCXSL2501074 Xing Lian Pharma (Suzhou) Co., Ltd. romanized
2025/12/12New drug · Class 1 注射用洛贝米柳 · No verified English nameCXHS2500154 Nanjing Ning Dan Xin Yao Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/12/12New drug · Class 2.4 戈利昔替尼胶囊 · No verified English nameCXHL2501383 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized
2025/12/11Generic · Class 3 Dexrazoxane for InjectionCYHS2504264 ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.
2025/12/11Generic · Class 3 Benzbromarone TabletsCYHS2504255 Zhejiang Hao Ge Pharma Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/12/11Generic · Class 3 Minoxidil LinimentCYHS2504247 Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized
2025/12/11Generic · Class 3 Minoxidil LinimentCYHS2504246 Bao Ding Tian Hao Pharmaceutical Co., Ltd. romanized
2025/12/11Generic · Class 3 左氧氟沙星滴耳液 · No verified English nameCYHS2504245 Yunnan Dai Yao Co., Ltd. romanized
2025/12/11New drug · Class 1.1 葛石通脉颗粒 · No verified English nameCXZL2500127 Zhongguo Zhong Yi Ke College Zhong Yi Lin Chuang Ji Chu Yi Xue Research Institute romanized
2025/12/11New drug · Class 1.1 清胆止痒颗粒 · No verified English nameCXZL2500126 Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized
2025/12/11New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2500140 Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized
2025/12/11New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2500139 Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized
2025/12/11New drug · Class 3.3 地舒单抗注射液 · No verified English nameCXSS2500138 Hua Lan An Kang Bio Co., Ltd. romanized
2025/12/11New drug · Class 1 FS-8002注射液 · No verified English nameCXSL2501073 Shanghai Pu Shi Pharmaceuticals Technology Co., Ltd. romanized
2025/12/11New drug · Class 1 自体天然肿瘤浸润淋巴细胞注射液 · No verified English nameCXSL2501072 Shanghai Jun Sai Bio Co., Ltd. romanized; Shanghai Jun Sai Bio Pharma Co., Ltd. romanized
2025/12/11New drug · Class 2.1; 2.3 SHR-2524注射液 · No verified English nameCXSL2501071 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/12/11New drug · Class 2.1; 2.3 SHR-2524注射液 · No verified English nameCXSL2501070 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2025/12/11New drug · Class 1 NS-136片 · No verified English nameCXHL2501382 Niu Ou Shen Pharmaceuticals (Shanghai) Co., Ltd. romanized
2025/12/11New drug · Class 1 NS-136片 · No verified English nameCXHL2501381 Niu Ou Shen Pharmaceuticals (Shanghai) Co., Ltd. romanized
2025/12/11New drug · Class 1 AN9025胶囊 · No verified English nameCXHL2501380 Hangzhou A Nuo Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/11New drug · Class 1 GW5282片 · No verified English nameCXHL2501379 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized; Ge Wu Bio Technology (Jiangsu) Co., Ltd. romanized
2025/12/11New drug · Class 1 AN9025胶囊 · No verified English nameCXHL2501378 Hangzhou A Nuo Biopharmaceuticals Technology Co., Ltd. romanized
2025/12/11New drug · Class 1 GW5282片 · No verified English nameCXHL2501377 Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized; Ge Wu Bio Technology (Jiangsu) Co., Ltd. romanized

103 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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