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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 339 drug applications between 14 January 2026 and 20 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 52 drug names.

2026/01/14 – 2026/01/20

Period
2026/01/14 to 2026/01/20, 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
339
Drugs with new generic filings (by drug name, de-duplicated)
52
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

339filings, 69 of them generic

By application type

Application typeFilings
Supplement168
Generic69
New drug59
Import34
Import re-registration5
Unspecified4

By drug type

Drug typeFilings
Chemical drug181
Therapeutic biologic77
TCM74
Prophylactic biologic6
Biologic1

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

52 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Loxoprofen Sodium Patches4230
2Dapagliflozin Tablets4284
3Mirogabalin Besilate Tablets3161
4西诺氨酯片 · No verified English name3124
5Deferasirox Tablets213
6头孢呋辛酯干混悬剂 · No verified English name215
7Telmisartan Tablets214
8维立西呱片 · No verified English name218
9Azilsartan Medoxomil Potassium Tablets2135
10Dasatinib Tablets214

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

202 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1830
2Hunan Jiu Dian Nuo Na Pharmaceuticals Technology Co., Ltd. romanized15150
3Rui Li Shi Wan Ting Min Xin Pharmaceutical Co., Ltd. romanized1120
4Boehringer Ingelheim International GmbH640
5Novartis Europharm Limited620
6Amgen Inc.530
7Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized510
8Hangzhou He Kang Pharma Co., Ltd. romanized423
9Hong Ji Tang Pharmaceutical (Lai Wu Qu) Co., Ltd. romanized330
10Hunan Jiudian Pharmaceutical Co., Ltd330

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

108 this week

AcceptedDrugApplicants
2026/01/20Import · Class 1 IMGN151注射液 · No verified English nameJXSL2600020 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/01/20Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600017 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/01/20Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600016 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/01/20Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600015 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/01/20Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600014 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/01/20Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600013 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/01/20Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600012 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/01/20Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600011 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/01/20Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600010 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/01/20Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600009 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/01/20Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600008 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/01/20Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600007 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/01/20Import · Class 1 NNC0487-0111注射液 · No verified English nameJXSL2600006 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/01/20Import · Class 1 PT0253注射液 · No verified English nameJXHL2600019 PAQ Therapeutics Inc.; Pharmaron (Chengdu) Clinical Services Co. Ltd.
2026/01/20Import · Class 1 BI3000202片 · No verified English nameJXHL2600018 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/01/20Import · Class 1 BI3000202片 · No verified English nameJXHL2600017 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/01/20Generic · Class 3 Pentoxifylline Modified Release TabletsCYHS2600230 Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized
2026/01/20Generic · Class 3 Brivaracetam Oral SolutionCYHS2600228 Chengdu Ao Bang Pharma Co., Ltd. romanized; Chengdu Li Er Pharma Co., Ltd. romanized
2026/01/20Generic · Class 3 Oseltamivir Phosphate For Oral SuspensionCYHS2600227 Jilin Sheng Wu Tai Gan Kang Pharma Co., Ltd. romanized
2026/01/20Generic · Class 3 阿普昔腾坦片 · No verified English nameCYHL2600013 CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD.
2026/01/20Generic · Class 3 注射用乳糖酸克拉霉素 · No verified English nameCYHL2600012 Shanghai Bo Zhi Yan Xin Drug Research Co., Ltd. romanized
2026/01/20New drug · Class 2.1 热毒宁颗粒 · No verified English nameCXZS2600004 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2026/01/20New drug · Class 1 注射用BL-B01D1 · No verified English nameCXSS2600012 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized
2026/01/20New drug · Class 1 注射用BR113 · No verified English nameCXSL2600108 Hangzhou Bo Zhi Rui Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized
2026/01/20New drug · Class 3.4 人纤维蛋白粘合剂 · No verified English nameCXSL2600104 Hua Run Bo Ya Biopharmaceutical Group Co., Ltd. romanized
2026/01/20New drug · Class 1 TST001注射液 · No verified English nameCXSL2600103 Suzhou Chuang Sheng Pharmaceuticals Group Co., Ltd. romanized
2026/01/20New drug · Class 1 HX011注射液 · No verified English nameCXSL2600102 Wuhan Hou Xian Biopharmaceuticals Co., Ltd. romanized
2026/01/20New drug · Class 3.3 帕妥珠曲妥珠单抗注射液(皮下注射) · No verified English nameCXSL2600101 Fu Xing Han Lin (Chengdu) Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2026/01/20New drug · Class 3.3 帕妥珠曲妥珠单抗注射液(皮下注射) · No verified English nameCXSL2600100 Fu Xing Han Lin (Chengdu) Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2026/01/20New drug · Class 1 SCTB41注射液 · No verified English nameCXSL2600099 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized

78 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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