YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 341 drug applications between 15 January 2026 and 21 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 66, covering 52 drug names.

2026/01/15 – 2026/01/21

Period
2026/01/15 to 2026/01/21, 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
341
Drugs with new generic filings (by drug name, de-duplicated)
52
Accepted this week, now under review
84

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

341filings, 66 of them generic

By application type

Application typeFilings
Supplement164
Generic66
New drug61
Import39
Unspecified10
Import re-registration1

By drug type

Drug typeFilings
Chemical drug197
Therapeutic biologic81
TCM60
Prophylactic biologic2
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
1Dapagliflozin Tablets4284
2Mirogabalin Besilate Tablets3161
3西诺氨酯片 · No verified English name3124
4Deferasirox Tablets213
5头孢呋辛酯干混悬剂 · No verified English name215
6Loxoprofen Sodium Patches2130
7维立西呱片 · No verified English name218
8Azilsartan Medoxomil Potassium Tablets2135
9Aripiprazole Tablets212
10Finasteride Tablets213

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

204 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1520
2Rui Li Shi Wan Ting Min Xin Pharmaceutical Co., Ltd. romanized1120
3Shaanxi Pharmaceuticals Holding Group Bio Zhi Pin (Han Zhong) Co., Ltd. romanized970
4Kashima Plant Eisai Co. Ltd.660
5Novartis Europharm Limited620
6Amgen Inc.530
7Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized510
8Hunan Jiu Dian Nuo Na Pharmaceuticals Technology Co., Ltd. romanized440
9Boehringer Ingelheim International GmbH430
10F. Hoffmann-La Roche Ltd430

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

116 this week

AcceptedDrugApplicants
2026/01/21Import · Class 1 Cevostamab · No verified English nameJXSL2600022 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2026/01/21Import · Class 1 Cevostamab · No verified English nameJXSL2600021 F. Hoffmann-La Roche Ltd; Roche(China)Holding Ltd.
2026/01/21Import · Class 1 PF-08634404 · No verified English nameJXSL2600019 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/01/21Import · Class 1 PF-08634404 · No verified English nameJXSL2600018 Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd.
2026/01/21Import · Class 1 Cenerimod片 · No verified English nameJXHL2600024 Viatris Innovation GmbH; Viatris Innovation (Beijing) Pharmaceuticals Co. Ltd
2026/01/21Import · Class 1 AZD3470薄膜衣片 · No verified English nameJXHL2600023 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/01/21Import · Class 1 AZD3470薄膜衣片 · No verified English nameJXHL2600022 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/01/21Import · Class 1 AZD3470薄膜衣片 · No verified English nameJXHL2600021 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/01/21Import · Class 1 AZD3470薄膜衣片 · No verified English nameJXHL2600020 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/01/21Generic · Class 3 Lorazepam TabletsCYHS2600244 Beijing Yi Min Pharma Co., Ltd. romanized
2026/01/21Generic · Class 3 二甲基亚砜冲洗液 · No verified English nameCYHS2600238 Beijing Bai Ao Pharma Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized
2026/01/21Generic · Class 3 Brivaracetam Solution for InjectionCYHS2600237 Chengdu Ao Bang Pharma Co., Ltd. romanized; Chengdu Li Er Pharma Co., Ltd. romanized
2026/01/21Generic · Class 3 Gabexate Mesilate For InjectionCYHS2600233 Hainan Brilliant Pharmaceutical Co., Ltd.
2026/01/21New drug · Class 3.1 清肺颗粒 · No verified English nameCXZS2600005 Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized
2026/01/21New drug · Class 3.4 德谷胰岛素利拉鲁肽注射液 · No verified English nameCXSS2600013 Nuo He Nuo De (Zhongguo) Pharmaceutical Co., Ltd. romanized; Name not romanized; Name not romanized
2026/01/21New drug · Class 1 ONC-841注射液 · No verified English nameCXSL2600115 Beijing Ang Ke Mian Yi Technology Co., Ltd. romanized
2026/01/21New drug · Class 1 XJ106-1注射液 · No verified English nameCXSL2600111 Xing Ji Biopharmaceuticals (Beijing) Co., Ltd. romanized
2026/01/21New drug · Class 1 LPJT-026 注射液 · No verified English nameCXSL2600110 Le Pu Jian Tang Pharma (Chongqing) Co., Ltd. romanized
2026/01/21New drug · Class 1 LPJT-026 注射液 · No verified English nameCXSL2600109 Le Pu Jian Tang Pharma (Chongqing) Co., Ltd. romanized
2026/01/21New drug · Class 1 注射用YK012 · No verified English nameCXSL2600107 Yi Ke Si Te (Beijing) Pharmaceuticals Technology Development Co., Ltd. romanized
2026/01/21New drug · Class 1 注射用YK012 · No verified English nameCXSL2600106 Yi Ke Si Te (Beijing) Pharmaceuticals Technology Development Co., Ltd. romanized
2026/01/21New drug · Class 1 注射用SSGJ-612 · No verified English nameCXSL2600105 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2026/01/21New drug · Class 1 RFUS-1646片 · No verified English nameCXHL2600097 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/01/21New drug · Class 1 RFUS-1646片 · No verified English nameCXHL2600096 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/01/21New drug · Class 1 ABA001注射液 · No verified English nameCXHL2600091 Beijing Yang Guang Nuo He Drug Research Co., Ltd. romanized; Beijing A Er Na Technology Co., Ltd. romanized; Beijing An Long Biopharmaceuticals Co., Ltd. romanized
2026/01/21New drug · Class 1 HRS-7156片 · No verified English nameCXHL2600090 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/01/21New drug · Class 1 HRS-7156片 · No verified English nameCXHL2600089 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
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

86 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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