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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 345 drug applications between 16 January 2026 and 22 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 72, covering 56 drug names.

2026/01/16 – 2026/01/22

Period
2026/01/16 to 2026/01/22, 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
345
Drugs with new generic filings (by drug name, de-duplicated)
56
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

345filings, 72 of them generic

By application type

Application typeFilings
Supplement149
Generic72
New drug72
Import39
Unspecified10
Import re-registration3

By drug type

Drug typeFilings
Chemical drug205
Therapeutic biologic82
TCM55
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

56 drugs with new generic filings; top 10 listed

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

212 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Novo Nordisk A/S1210
2Shaanxi Pharmaceuticals Holding Group Bio Zhi Pin (Han Zhong) Co., Ltd. romanized970
3Kashima Plant Eisai Co. Ltd.660
4Novartis Europharm Limited620
5Shanghai Kai Mao Biopharmaceuticals Co., Ltd. romanized510
6Qilu Pharmaceutical Co., Ltd.441
7Boehringer Ingelheim International GmbH430
8F. Hoffmann-La Roche Ltd430
9Pfizer Inc.430
10Amgen Inc.420

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

130 this week

AcceptedDrugApplicants
2026/01/22Import · Class 2.2 马塔西单抗注射液 · No verified English nameJXSS2600005 Pfizer Inc.; Pfizer Manufacturing Belgium NV; Pfizer Investment Co. Ltd.
2026/01/22Import · Class 2.4 LOU064片 · No verified English nameJXHL2600026 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/01/22Import · Class 2.4 LOU064片 · No verified English nameJXHL2600025 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/01/22Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2600256 Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Shandong Jian Dao Pharmaceutical Co., Ltd. romanized
2026/01/22Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2600255 Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized; Shandong Jian Dao Pharmaceutical Co., Ltd. romanized
2026/01/22Generic · Class 3 Nimodipine Oral SolutionCYHS2600251 Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2026/01/22Generic · Class 3 Nimodipine Oral SolutionCYHS2600250 Wen Ling Shi Innovation Biopharmaceuticals Technology Co., Ltd. romanized; Wan Bang De Pharmaceutical Group Co., Ltd. romanized
2026/01/22New drug · Class 1.1 参灵颗粒 · No verified English nameCXZL2600010 Zhejiang Zuo Li Pharma Co., Ltd. romanized
2026/01/22New drug · Class 1.2 障复康胶囊 · No verified English nameCXZL2600009 Gan Jiang Xin Qu Ai Ze Biopharmaceuticals Technology Co., Ltd. romanized
2026/01/22New drug · Class 1.2 木蝴蝶总黄酮提取物 · No verified English nameCXZL2600008 Gan Jiang Xin Qu Ai Ze Biopharmaceuticals Technology Co., Ltd. romanized
2026/01/22New drug · Class 1.1 柴黄降逆颗粒 · No verified English nameCXZL2600007 Beijing Hui Cui Pharmaceuticals Technology Co., Ltd. romanized
2026/01/22New drug · Class 1 JKN2401注射液 · No verified English nameCXSL2600121 Health Yuan Pharma Group Co., Ltd. romanized
2026/01/22New drug · Class 1 PM8002注射液 · No verified English nameCXSL2600120 Bai Ou En Tai (Zhuhai) Pharmaceuticals Research and Development Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/01/22New drug · Class 1 注射用ZG006 · No verified English nameCXSL2600119 Name not romanized; Name not romanized
2026/01/22New drug · Class 1 注射用ZG006 · No verified English nameCXSL2600118 Name not romanized; Name not romanized
2026/01/22New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2600117 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/01/22New drug · Class 1 注射用BAT8008 · No verified English nameCXSL2600116 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2026/01/22New drug · Class 2.2 帕博利珠单抗注射液 · No verified English nameCXSL2600114 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2026/01/22New drug · Class 3.3 西妥昔单抗注射液 · No verified English nameCXSL2600113 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Fu Xing Han Lin (Chengdu) Bio Technology Co., Ltd. romanized
2026/01/22New drug · Class 1 注射用DB-1310 · No verified English nameCXSL2600112 Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/01/22New drug · Class 1 WGI-0301 · No verified English nameCXHL2600103 Zhejiang Hai Chang Biopharmaceuticals Co., Ltd. romanized
2026/01/22New drug · Class 2.4 泽布替尼胶囊 · No verified English nameCXHL2600102 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/01/22New drug · Class 1 RFUS-1646片 · No verified English nameCXHL2600101 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/01/22New drug · Class 1 RFUS-1646片 · No verified English nameCXHL2600100 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/01/22New drug · Class 1 GLR2037片 · No verified English nameCXHL2600099 Gan Li Pharma Co., Ltd. romanized
2026/01/22New drug · Class 1 GLR2037片 · No verified English nameCXHL2600098 Gan Li Pharma Co., Ltd. romanized
2026/01/22New drug · Class 2.2 SMLT24013片 · No verified English nameCXHL2600095 Shaanxi Pharmaceuticals Holding Group Bio Zhi Pin Co., Ltd. romanized
2026/01/22New drug · Class 2.1 盐酸左沙丁胺醇异丙托溴铵吸入溶液 · No verified English nameCXHL2600094 Jinan Jing Sheng Technology Co., Ltd. romanized
2026/01/22New drug · Class 1 KBD104409片 · No verified English nameCXHL2600093 Kang Bai Da (Sichuan) Biopharmaceuticals Technology Co., Ltd. romanized
2026/01/22New drug · Class 1 KBD104409片 · No verified English nameCXHL2600092 Kang Bai Da (Sichuan) Biopharmaceuticals Technology Co., Ltd. romanized

100 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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