YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 416 drug applications between 30 January 2026 and 5 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 78, covering 54 drug names.

2026/01/30 – 2026/02/05

Period
2026/01/30 to 2026/02/05, 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
416
Drugs with new generic filings (by drug name, de-duplicated)
54
Accepted this week, now under review
115

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

416filings, 78 of them generic

By application type

Application typeFilings
Supplement236
Generic78
New drug62
Unspecified16
Import re-registration16
Import8

By drug type

Drug typeFilings
Chemical drug214
TCM149
Therapeutic biologic45
Biologic8

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

54 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

197 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized60460
2Ha Yao Group Bio Gong Cheng Co., Ltd. romanized1680
3Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized930
4Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized660
5Bayer AG620
6Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized620
7Jiangsu Hao Sen Pharma Group Co., Ltd. romanized610
8Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized550
9Jiangxi Wang Shi Pharma Co., Ltd. romanized550
10Ai Min Pharma Group Co., Ltd. romanized550

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

96 this week

AcceptedDrugApplicants
2026/02/05Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2600381 Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized
2026/02/05Generic · Class 3 盐酸溴己新吸入溶液 · No verified English nameCYHS2600380 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2026/02/05Generic · Class 3 盐酸溴己新吸入溶液 · No verified English nameCYHS2600379 Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized
2026/02/05Generic · Class 3 Cyclophosphamide InjectionCYHS2600376 Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized
2026/02/05Generic · Class 3 Cyclophosphamide InjectionCYHS2600375 Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized
2026/02/05Generic · Class 3 Cyclophosphamide InjectionCYHS2600374 Ji Si Mei (Wuhan) Pharmaceutical Co., Ltd. romanized
2026/02/05Generic · Class 3 Ferrous Succinate TabletsCYHS2600370 Zhejiang Yuan Li Jian Pharma Co., Ltd. romanized
2026/02/05New drug · Class 1.1 双鱼颗粒 · No verified English nameCXZS2600012 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2026/02/05New drug · Class 3.1 一贯煎颗粒 · No verified English nameCXZS2600011 Jiu Zhi Tang Co., Ltd. romanized
2026/02/05New drug · Class 1.1 清润养目颗粒 · No verified English nameCXZL2600021 Shanghai Pharmaceuticals Group Zhong Yao Research Institute Co., Ltd. romanized
2026/02/05New drug · Class 1 9MW2821 · No verified English nameCXSL2600177 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2026/02/05New drug · Class 1 CVL006注射液 · No verified English nameCXSL2600176 Fu Kang Bio Technology (Shanghai) Co., Ltd. romanized
2026/02/05New drug · Class 2.2 注射用MK-2870 · No verified English nameCXSL2600175 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2026/02/05New drug · Class 2.2 注射用MK-2870 · No verified English nameCXSL2600174 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2026/02/05New drug · Class 3.3 LPS-001片 · No verified English nameCXSL2600173 Le Pu Pharma Co., Ltd. romanized
2026/02/05New drug · Class 3.3 LPS-001片 · No verified English nameCXSL2600172 Le Pu Pharma Co., Ltd. romanized
2026/02/05New drug · Class 3.3 LPS-001片 · No verified English nameCXSL2600171 Le Pu Pharma Co., Ltd. romanized
2026/02/05New drug · Class 1 IVB107 注射液 · No verified English nameCXSL2600170 Beijing Nuo Wei Biopharmaceuticals Technology Co., Ltd. romanized
2026/02/05New drug · Class 1 SCTB35注射液 · No verified English nameCXSL2600169 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/02/05New drug · Class 1 SCTB35注射液 · No verified English nameCXSL2600168 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/02/05New drug · Class 1 HS-20136注射液 · No verified English nameCXHL2600151 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/02/05New drug · Class 1 HS-20136注射液 · No verified English nameCXHL2600150 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/02/05New drug · Class 1 HS-20136注射液 · No verified English nameCXHL2600149 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/02/05New drug · Class 1 HS-20136注射液 · No verified English nameCXHL2600148 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/02/05New drug · Class 1 HS-20136注射液 · No verified English nameCXHL2600147 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/02/05New drug · Class 1 HS-20136注射液 · No verified English nameCXHL2600146 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2026/02/05New drug · Class 1 INS018_055B雾化吸入剂 · No verified English nameCXHL2600145 Ying Xi Zhi Neng Technology (Shanghai) Co., Ltd. romanized
2026/02/04Generic · Class 3 Bifonazole SolutionCYHS2600356 Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2026/02/04Generic · Class 3 托吡酯口服溶液 · No verified English nameCYHS2600354 Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized
2026/02/04Generic · Class 3 Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2600353 Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized

66 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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