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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 384 drug applications between 17 December 2025 and 23 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 71, covering 47 drug names.

2025/12/17 – 2025/12/23

Period
2025/12/17 to 2025/12/23, 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
384
Drugs with new generic filings (by drug name, de-duplicated)
47
Accepted this week, now under review
80

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

384filings, 71 of them generic

By application type

Application typeFilings
Supplement199
New drug90
Generic71
Unspecified10
Import7
Import re-registration7

By drug type

Drug typeFilings
Chemical drug193
TCM125
Therapeutic biologic58
Biologic5
Prophylactic biologic3

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

47 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Loxoprofen Sodium Patches4230
2Baricitinib Tablets3232
3Finerenone Tablets3269
4Lidocaine and Prilocaine Cream3124
5Sildenafil Citrate Tablets3112
6Oseltamivir Phosphate Capsules3139
7草酸艾司西酞普兰口服溶液 · No verified English name3111
8Colistimethate Sodium for Injection222
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

203 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Sheng De Shang Pharma Co., Ltd. romanized46390
2Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized11110
3Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized1020
4Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized830
5Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
6Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized550
7Ha Yao Group San Jing Er Tong Da Pharmaceutical Factory (Co., Ltd.) romanized530
8Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized535
9Name not 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

117 this week

AcceptedDrugApplicants
2025/12/23Import · Class 1 Frexalimab注射液 · No verified English nameJXSL2500245 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2025/12/23Generic · Class 3 Haloperidol Oral SolutionCYHS2504360 Hainan Si Da Pharmaceutical Co., Ltd. romanized
2025/12/23Generic · Class 3 Paracetamol And Ibuprofen Oral SuspensionCYHS2504357 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/12/23Generic · Class 3 贝美前列素涂剂 · No verified English nameCYHL2500228 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2025/12/23Generic · Class 3 Colistimethate Sodium for InjectionCYHL2500227 Hebei Sheng Xue Da Cheng Pharmaceutical Co., Ltd. romanized
2025/12/23Generic · Class 3 氟[18F]妥西吡注射液 · No verified English nameCYHL2500226 Hangzhou Yi Li Pharmaceuticals Co., Ltd. romanized
2025/12/23New drug · Class 3.3 QL2109注射液 · No verified English nameCXSL2501120 Qilu Pharmaceutical Co., Ltd.
2025/12/23New drug · Class 1 JWK001注射液 · No verified English nameCXSL2501116 Chengdu Jin Wei Ke Bio Technology Co., Ltd. romanized
2025/12/23New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2501115 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/12/23New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2501114 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/12/23New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2501113 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/12/23New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2501112 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/12/23New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSL2501111 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2025/12/23New drug · Class 1 GK01活菌散 · No verified English nameCXSL2501110 Zhejiang Mai Ya Ta Jun Jian Zhi Neng Technology Co., Ltd. romanized
2025/12/23New drug · Class 3.2 皮下注射人免疫球蛋白 · No verified English nameCXSL2501109 Shenzhen Shi Wei Guang Bio Zhi Pin Co., Ltd. romanized
2025/12/23New drug · Class 1 GC801注射液 · No verified English nameCXSL2501108 Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized
2025/12/23New drug · Class 1 RX608片 · No verified English nameCXHL2501445 Suzhou Run Xin Bio Technology Co., Ltd. romanized
2025/12/23New drug · Class 1 RX608片 · No verified English nameCXHL2501444 Suzhou Run Xin Bio Technology Co., Ltd. romanized
2025/12/23New drug · Class 1 VG081821AC片 · No verified English nameCXHL2501443 Zhejiang Chun He Pharmaceuticals Technology Co., Ltd. romanized
2025/12/23New drug · Class 1 VG081821AC片 · No verified English nameCXHL2501442 Zhejiang Chun He Pharmaceuticals Technology Co., Ltd. romanized
2025/12/23New drug · Class 1 VG081821AC片 · No verified English nameCXHL2501441 Zhejiang Chun He Pharmaceuticals Technology Co., Ltd. romanized
2025/12/23New drug · Class 1 D3S-002片 · No verified English nameCXHL2501440 Name not romanized
2025/12/23New drug · Class 1 D3S-002片 · No verified English nameCXHL2501439 Name not romanized
2025/12/23New drug · Class 1 D3S-002片 · No verified English nameCXHL2501438 Name not romanized
2025/12/23New drug · Class 2.4 Regadenoson InjectionCXHL2501437 Jiangxi Yin Tao Pharma Co., Ltd. romanized
2025/12/23New drug · Class 1 D3S-002片 · No verified English nameCXHL2501436 Name not romanized
2025/12/23New drug · Class 1 D3S-001胶囊 · No verified English nameCXHL2501435 Name not romanized
2025/12/23New drug · Class 1 BL0020注射液 · No verified English nameCXHL2501434 Shanghai Bi Ling Bio Technology Co., Ltd. romanized
2025/12/23New drug · Class 1 INT-210胶囊 · No verified English nameCXHL2501433 Yi Kun Xing Jian Biopharmaceuticals (Shanghai) Co., Ltd. romanized
2025/12/23New drug · Class 1 INT-210胶囊 · No verified English nameCXHL2501432 Yi Kun Xing Jian Biopharmaceuticals (Shanghai) Co., Ltd. romanized

87 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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