YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 545 drug applications between 3 January 2026 and 9 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 135, covering 91 drug names.

2026/01/03 – 2026/01/09

Period
2026/01/03 to 2026/01/09, 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
545
Drugs with new generic filings (by drug name, de-duplicated)
91
Accepted this week, now under review
186

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

545filings, 135 of them generic

By application type

Application typeFilings
Supplement236
New drug142
Generic135
Unspecified16
Import13
Import re-registration3

By drug type

Drug typeFilings
Chemical drug329
TCM107
Therapeutic biologic97
Biologic6
Prophylactic biologic6

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

91 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

308 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Nei Menggu Da Tang Pharma Co., Ltd. romanized15150
2Shenzhen Xin Li Tai Pharma Co., Ltd. romanized1320
3Sichuan Tian De Pharmaceutical Co., Ltd. romanized990
4Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized990
5Gan Li Pharma Shandong Co., Ltd. romanized910
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized820
7Janssen-Cilag International NV810
8Guangdong Wan Nian Qing Pharmaceutical Co., Ltd. romanized660
9ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.626
10Name not romanized610

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

186 this week

AcceptedDrugApplicants
2026/01/09Import · Class 2.4 宗艾替尼片 · No verified English nameJXHL2600008 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd
2026/01/09Generic · Class 3 Metformin Hydrochloride Oral SolutionCYHS2600123 Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/01/09Generic · Class 3 托吡酯口服溶液 · No verified English nameCYHS2600116 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2026/01/09Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2600112 Zhejiang Nord Pharmaceutical Co., Ltd
2026/01/09Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2600110 Hua Ren Pharma (Ri Zhao) Co., Ltd. romanized
2026/01/09Generic · Class 3 盐酸伊伐布雷定口服溶液 · No verified English nameCYHS2600105 Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2026/01/09Generic · Class 3 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2600101 Shaanxi Xiang Ju Pharma Group Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2026/01/09Generic · Class 3 贝美前列素涂剂 · No verified English nameCYHL2600004 Fu Yuan Pharma Co., Ltd. romanized
2026/01/09New drug · Class 3.3 阿达木单抗注射液 · No verified English nameCXSS2600006 Hua Lan An Kang Bio Co., Ltd. romanized
2026/01/09New drug · Class 1 GR1803注射液 · No verified English nameCXSS2600003 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2026/01/09New drug · Class 1 SCTC21C注射液 · No verified English nameCXSL2600049 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/01/09New drug · Class 1.2 YKYY026注射液 · No verified English nameCXSL2600048 Beijing Yue Kang Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Hangzhou Tian Long Pharma Co., Ltd. romanized
2026/01/09New drug · Class 1 注射用BR2060 · No verified English nameCXSL2600047 Hangzhou Bo Zhi Rui Biopharmaceutical Co., Ltd. romanized; Zhejiang Bo Rui Biopharmaceutical Co., Ltd. romanized
2026/01/09New drug · Class 2.2 注射用维贝柯妥塔单抗 · No verified English nameCXSL2600046 Le Pu Bio Technology Co., Ltd. romanized
2026/01/09New drug · Class 1 LAE102注射液 · No verified English nameCXSL2600045 Lai Kai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/01/09New drug · Class 1 重组人血小板源生长因子凝胶 · No verified English nameCXSL2600042 Name not romanized
2026/01/09New drug · Class 1 重组人血小板源生长因子凝胶 · No verified English nameCXSL2600041 Name not romanized
2026/01/09New drug · Class 1 重组人血小板源生长因子凝胶 · No verified English nameCXSL2600040 Name not romanized
2026/01/09New drug · Class 1 重组人血小板源生长因子凝胶 · No verified English nameCXSL2600039 Name not romanized
2026/01/09New drug · Class 1 重组人血小板源生长因子凝胶 · No verified English nameCXSL2600038 Name not romanized
2026/01/09New drug · Class 1 重组人血小板源生长因子凝胶 · No verified English nameCXSL2600037 Name not romanized
2026/01/09New drug · Class 1 SCTB41注射液 · No verified English nameCXSL2600035 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2026/01/09New drug · Class 2.6 吸附无细胞百白破(组分)联合疫苗(成人青少年及儿童用) · No verified English nameCXSL2600034 Beijing Min Hai Bio Technology Co., Ltd. romanized
2026/01/09New drug · Class 2.4 Nalbuphine Hydrochloride InjectionCXHS2600013 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/01/09New drug · Class 2.4 Nalbuphine Hydrochloride InjectionCXHS2600012 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/01/09New drug · Class 2.4 Nalbuphine Hydrochloride InjectionCXHS2600011 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/01/09New drug · Class 1 丁二酸复瑞替尼胶囊 · No verified English nameCXHS2600010 Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized
2026/01/09New drug · Class 2.3 普卢格列汀二甲双胍缓释片 · No verified English nameCXHS2600009 CSPC OUYI PHARMACEUTICAL CO., LTD.
2026/01/09New drug · Class 2.3 普卢格列汀二甲双胍缓释片 · No verified English nameCXHS2600008 CSPC OUYI PHARMACEUTICAL CO., LTD.
2026/01/09New drug · Class 1 QLS1317片 · No verified English nameCXHL2600057 Shanghai Qi Lu Pharmaceutical Research Center Co., Ltd. romanized

156 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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