YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 460 drug applications between 16 August 2026 and 22 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 51 drug names.

2026/08/16 – 2026/08/22

Period
2026/08/16 to 2026/08/22, 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
460
Drugs with new generic filings (by drug name, de-duplicated)
51
Accepted this week, now under review
234

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

460filings, 69 of them generic

By application type

Application typeFilings
Supplement264
New drug72
Generic69
Import42
Import re-registration7
Unspecified6

By drug type

Drug typeFilings
Chemical drug218
TCM148
Therapeutic biologic81
Prophylactic biologic10
Biologic3

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

51 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

275 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanghai Min Wei Bio Technology Co., Ltd. romanized1410
2Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized1130
3Eli Lilly and Company820
4Novo Nordisk A/S820
5Pfizer Inc.740
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized720
7Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized660
8Jilin Dao Jun Pharma Co., Ltd. romanized660
9AbbVie Inc.520
10Jilin Gao Miao Pharma Co., Ltd. romanized440

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

129 this week

AcceptedDrugApplicants
2026/08/21Import · Class 3.1 20价肺炎球菌多糖结合疫苗 · No verified English nameJXSL2600221 Pfizer Europe MA EEIG; Pfizer Investment CO. Ltd.
2026/08/21Import · Class 1 注射用BMS-986525 · No verified English nameJXSL2600220 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/08/21Import · Class 2.2 MK-3475A注射液 · No verified English nameJXSL2600219 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/08/21Import · Class 2.2 MK-3475A注射液 · No verified English nameJXSL2600218 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/08/21Import · Class 1 [111In]In-FL-261注射液 · No verified English nameJXHL2600359 Full-Life Techinologies UK Limited; Shanghai Full-life Technologies Co. Ltd.
2026/08/21Import · Class 1 [225Ac]Ac-FL-261注射液 · No verified English nameJXHL2600358 Full-Life Techinologies UK Limited; Shanghai Full-Life Technologies Co. Ltd
2026/08/21Generic · Class 3 Brivaracetam TabletsCYHS2602090 Zhejiang Nord Pharmaceutical Co., Ltd
2026/08/21Generic · Class 3 Brivaracetam TabletsCYHS2602089 Zhejiang Nord Pharmaceutical Co., Ltd
2026/08/21Generic · Class 3 Brivaracetam TabletsCYHS2602088 Zhejiang Nord Pharmaceutical Co., Ltd
2026/08/21Generic · Class 3 中性腹膜透析液(乳酸盐-G1.35%) · No verified English nameCYHS2602086 Hebei Tian Cheng Pharma Co., Ltd. romanized
2026/08/21Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2602085 Hebei Guang Xiang Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2026/08/21Generic · Class 3 Doxycycline Hyclate for InjectionCYHS2602083 Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized
2026/08/21Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2602082 Shi Yao Yin Hu Pharmaceutical Co., Ltd. romanized
2026/08/21Generic · Class 3 Mesalazine Gastro-Resistant Prolonged-Release GranulesCYHS2602081 Shanghai Hui Yong Pharmaceutical Co., Ltd. romanized
2026/08/21New drug · Class 2.2 YFZ-002 · No verified English nameCXZL2600079 Su Zhou Yi Fan Pharma Co., Ltd. romanized
2026/08/21New drug · Class 2.2 YFZ-002 · No verified English nameCXZL2600078 Su Zhou Yi Fan Pharma Co., Ltd. romanized
2026/08/21New drug · Class 1 注射用奥帕替苏米单抗 · No verified English nameCXSS2600131 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized; Yan Tai Mai Bai Rui International Biopharmaceuticals Co., Ltd. romanized
2026/08/21New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2600895 Shenzhen Shi Yin Guan Bio Technology Co., Ltd. romanized
2026/08/21New drug · Class 2.2 信迪利单抗注射液 · No verified English nameCXSL2600894 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/08/21New drug · Class 3.2 蛋白C · No verified English nameCXSL2600893 Guangxi Lai Shi Biopharmaceutical Co., Ltd. romanized
2026/08/21New drug · Class 1 Pumitamig注射液 · No verified English nameCXSL2600892 Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/08/21New drug · Class 2.2 注射用MK-2870 · No verified English nameCXSL2600891 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2026/08/21New drug · Class 2.2 注射用MK-2870 · No verified English nameCXSL2600890 Mo Sha Dong Research and Development (Zhongguo) Co., Ltd. romanized
2026/08/21New drug · Class 2.2 HRG2010胶囊 · No verified English nameCXHS2600121 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/21New drug · Class 2.2 HRG2010胶囊 · No verified English nameCXHS2600120 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/08/21New drug · Class 2.2; 2.3; 2.4 纳曲酮利培酮植入剂 · No verified English nameCXHL2601038 Shenzhen Shan Kang Pharmaceuticals Technology Co., Ltd. romanized
2026/08/21New drug · Class 1 HJ065片 · No verified English nameCXHL2601037 Hua Jian Wei Lai (Chengdu) Technology Co., Ltd. romanized
2026/08/21New drug · Class 1 HJ065片 · No verified English nameCXHL2601036 Hua Jian Wei Lai (Chengdu) Technology Co., Ltd. romanized
2026/08/21New drug · Class 1 奥莱泊肽注射液 · No verified English nameCXHL2601035 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized
2026/08/21New drug · Class 1 奥莱泊肽注射液 · No verified English nameCXHL2601034 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized

99 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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