YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 413 drug applications between 6 October 2026 and 12 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 73, covering 49 drug names.

2026/10/06 – 2026/10/12

Period
2026/10/06 to 2026/10/12, 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
413
Drugs with new generic filings (by drug name, de-duplicated)
49
Accepted this week, now under review
367

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

413filings, 73 of them generic

By application type

Application typeFilings
Supplement217
New drug76
Generic73
Import21
Import re-registration18
Unspecified8

By drug type

Drug typeFilings
Chemical drug218
TCM118
Therapeutic biologic75
Biologic2

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

49 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Allopurinol Tablets324
2Ixazomib Citrate Capsules317
3Dihydrocodeine Tartrate Sustained Realese Tablets313
4二硫化硒洗剂 · No verified English name2214
5Glucosamine Sulfate Capsules2251
6Mupirocin Ointment2230
7Dotinurad Tablets2155
8Emedastine Difumarate Sustained-release Capsules2111
9Brivaracetam Tablets2119
10Ticagrelor Tablets2110

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

235 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Dong E E Jiao Co., Ltd. romanized11110
2Pfizer Inc.920
3Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized820
4N. V. Organon810
5Kunming Zhong Pharmaceutical Factory Co., Ltd. romanized770
6Guangxi Bao Rui Tan Pharmaceutical Co., Ltd. romanized640
7Upjohn Manufacturing Ireland Unlimited Company610
8Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized610
9AstraZeneca AB530
10Merck Europe B.V.520

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

128 this week

AcceptedDrugApplicants
2026/10/12Import · Class 2.2 法瑞西单抗注射液 · No verified English nameJXSS2600091 Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG
2026/10/12Import · Class 2.2 法瑞西单抗注射液 · No verified English nameJXSS2600090 Roche Pharma (Schweiz) AG; Vetter Pharma-Fertigung GmbH & Co. KG
2026/10/12Import · Class 2.2 泰它西普注射液 · No verified English nameJXSL2600271 Vor Biopharma Inc.; RemeGen Co. Ltd.
2026/10/12Import · Class 1 LY888891混悬液 · No verified English nameJXSL2600270 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/10/12Import · Class 1 LY5830966片 · No verified English nameJXHL2600440 Ajax Therapeutics Inc. (a wholly owned subsidiary of Eli Lilly and Company); Lilly Suzhou Pharmaceutical Co. Ltd.
2026/10/12Import · Class 1 Fenebrutinib片 · No verified English nameJXHL2600439 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/10/12Generic · Class 3 Emedastine Difumarate Sustained-release CapsulesCYHS2602503 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Guangdong Hao Rui En Pharmaceutical Co., Ltd. romanized
2026/10/12Generic · Class 3 Emedastine Difumarate Sustained-release CapsulesCYHS2602502 Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Guangdong Hao Rui En Pharmaceutical Co., Ltd. romanized
2026/10/12Generic · Class 3 Allopurinol TabletsCYHS2602495 Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized
2026/10/12Generic · Class 3 Timolol Maleate Eye DropsCYHS2602494 Chengdu Pusch Pharmaceutical Co., Ltd.
2026/10/12Generic · Class 3 Timolol Maleate Eye DropsCYHS2602493 Chengdu Pusch Pharmaceutical Co., Ltd.
2026/10/12Generic · Class 3 Sodium Cromoglicate Eye DropsCYHS2602492 Chengdu Pusch Pharmaceutical Co., Ltd.
2026/10/12Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2602491 Shandong Nuo He Kang Pharma Co., Ltd. romanized
2026/10/12Generic · Class 3 尿素[14C]胶囊 · No verified English nameCYHL2600114 Hunan Sai Li Si Yi Xue Bio Technology Co., Ltd. romanized
2026/10/12Generic · Class 3 美阿沙坦钾氯噻酮片 · No verified English nameCYHL2600113 Beijing Foyou Pharma CO.,LTD
2026/10/12Generic · Class 3 美阿沙坦钾氯噻酮片 · No verified English nameCYHL2600112 Beijing Foyou Pharma CO.,LTD
2026/10/12New drug · Class 3.1 半夏白术天麻汤颗粒 · No verified English nameCXZS2600053 Shen Wei Pharma Group Co., Ltd. romanized
2026/10/12New drug · Class 2.2 消炎解毒合剂 · No verified English nameCXZL2600098 Hubei Yi En Pharma Co., Ltd. romanized
2026/10/12New drug · Class 1 注射用GB268 · No verified English nameCXSL2601106 Yi Teng Pharmaceuticals (Zhuhai) Co., Ltd. romanized
2026/10/12New drug · Class 1 QH104A细胞注射液 · No verified English nameCXSL2601105 Beijing Qing Hui Lian Nuo Bio Technology Co., Ltd. romanized
2026/10/12New drug · Class 1 抗狂犬病病毒全人源组合抗体注射液 · No verified English nameCXSL2601104 Liaoning Cheng Da Bio Co., Ltd. romanized; Beijing Cheng Da Tian He Bio Technology Co., Ltd. romanized
2026/10/12New drug · Class 2.2 注射用泰它西普 · No verified English nameCXSL2601103 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2026/10/12New drug · Class 1 注射用LM-338 · No verified English nameCXSL2601102 Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/10/12New drug · Class 1 注射用QLS5314 · No verified English nameCXSL2601101 Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized
2026/10/12New drug · Class 1 注射用HS-20122 · No verified English nameCXSL2601100 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/10/12New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2601099 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/10/12New drug · Class 1 SYS6072 · No verified English nameCXSL2601098 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/10/12New drug · Class 1 9MW5211注射液 · No verified English nameCXSL2601097 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2026/10/12New drug · Class 2.4 盐酸吉卡昔替尼片 · No verified English nameCXHS2600137 Name not romanized
2026/10/12New drug · Class 1 HP570片 · No verified English nameCXHL2601261 Hai Chuang Pharma Co., Ltd. romanized

98 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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