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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 397 drug applications between 16 December 2025 and 22 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 70, covering 43 drug names.

2025/12/16 – 2025/12/22

Period
2025/12/16 to 2025/12/22, 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
397
Drugs with new generic filings (by drug name, de-duplicated)
43
Accepted this week, now under review
89

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

397filings, 70 of them generic

By application type

Application typeFilings
Supplement221
New drug81
Generic70
Import9
Unspecified8
Import re-registration8

By drug type

Drug typeFilings
Chemical drug200
TCM124
Therapeutic biologic67
Biologic4
Prophylactic biologic2

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

43 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Mirogabalin Besilate Tablets4161
2Baricitinib Tablets3232
3Finerenone Tablets3269
4Lidocaine and Prilocaine Cream3124
5Sildenafil Citrate Tablets3112
6草酸艾司西酞普兰口服溶液 · No verified English name3111
7Nystatin Oral Suspension223
8Glucosamine Sulfate Capsules2251
9利伐沙班口崩片 · No verified English name214
10Divalproex Sodium Extended-Release Tablets210

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

220 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng De Shang Pharma Co., Ltd. romanized38320
2Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized12120
3Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized830
4Novo Nordisk A/S820
5Ha Yao Group San Jing Er Tong Da Pharmaceutical Factory (Co., Ltd.) romanized640
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
7Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized550
8Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized535
9Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized520
10Beijing Lian Er Tang 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

110 this week

AcceptedDrugApplicants
2025/12/22Import · Class 2.2 注射用德达博妥单抗 · No verified English nameJXSS2500151 Daiichi Sankyo Europe GmbH; Simtra Deutschland GmbH
2025/12/22Import · Class 1 注射用MK-2400 · No verified English nameJXSL2500244 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2025/12/22Import · Class 2.2; 2.1 泰它西普注射液 · No verified English nameJXSL2500243 Vor Biopharma Inc.; RemeGen Co. Ltd.
2025/12/22Import · Class 1 AZD5305 · No verified English nameJXHL2500389 AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd.
2025/12/22Generic · Class 3 Verapamil Hydrochloride InjectionCYHS2504349 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2025/12/22Generic · Class 3 利伐沙班口崩片 · No verified English nameCYHS2504348 Jiangxi Shimei Pharmaceutical Co., Ltd
2025/12/22Generic · Class 3 利伐沙班口崩片 · No verified English nameCYHS2504347 Jiangxi Shimei Pharmaceutical Co., Ltd
2025/12/22Generic · Class 3 Ketorolac Trometamol TabletsCYHS2504346 Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd.
2025/12/22Generic · Class 3 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2504343 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2025/12/22Generic · Class 3 唑尼沙胺片 · No verified English nameCYHS2504341 Hunan Shang Zhong He Biopharmaceuticals Co., Ltd. romanized; Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized
2025/12/22Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2504337 Haerbin Shi Kang Long Pharma Co., Ltd. romanized
2025/12/22Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2504336 Haerbin Shi Kang Long Pharma Co., Ltd. romanized
2025/12/22Generic · Class 3 草酸艾司西酞普兰口服溶液 · No verified English nameCYHS2504335 Haerbin Shi Kang Long Pharma Co., Ltd. romanized
2025/12/22New drug · Class 3.4 人凝血酶原复合物 · No verified English nameCXSS2500143 Yuan Da Shu Yang Sheng Ming Ke Xue (Chengdu) Co., Ltd. romanized
2025/12/22New drug · Class 1 注射用LNF2105 · No verified English nameCXSL2501107 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2025/12/22New drug · Class 1 NT-001注射液 · No verified English nameCXSL2501106 Shanghai Nai Kang Bio Technology Co., Ltd. romanized
2025/12/22New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2501105 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/12/22New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2501104 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/12/22New drug · Class 1 610细胞注射液 · No verified English nameCXSL2501103 Beijing Ka Ti Medical Technology Co., Ltd. romanized
2025/12/22New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2501102 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/12/22New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2501101 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/12/22New drug · Class 2.2 伊基奥仑赛注射液 · No verified English nameCXSL2501100 Nanjing Xun Lu Biopharmaceuticals Co., Ltd. romanized
2025/12/22New drug · Class 1 INT-210胶囊 · No verified English nameCXHL2501428 Yi Kun Xing Jian Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2025/12/22New drug · Class 1 INT-210胶囊 · No verified English nameCXHL2501427 Yi Kun Xing Jian Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2025/12/22New drug · Class 1 H021肠溶片 · No verified English nameCXHL2501426 Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized
2025/12/22New drug · Class 2.3 BTP4327 · No verified English nameCXHL2501425 Jiangsu Nuo He Bi Tuo Xin Yao Research and Development Co., Ltd. romanized; Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized; Beijing Bai Ao Pharma Co., Ltd. romanized
2025/12/22New drug · Class 1 HSK46575片 · No verified English nameCXHL2501424 Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2025/12/22New drug · Class 1 HSK46575片 · No verified English nameCXHL2501423 Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2025/12/22New drug · Class 1 HSK46575片 · No verified English nameCXHL2501422 Liaoning Hai Si Ke Pharmaceutical Co., Ltd. romanized
2025/12/22New drug · Class 1 RGT-274-CR胶囊 · No verified English nameCXHL2501419 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized

80 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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