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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 516 drug applications between 12 August 2026 and 18 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 81, covering 57 drug names.

2026/08/12 – 2026/08/18

Period
2026/08/12 to 2026/08/18, 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
516
Drugs with new generic filings (by drug name, de-duplicated)
57
Accepted this week, now under review
252

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

516filings, 81 of them generic

By application type

Application typeFilings
Supplement310
Generic81
New drug66
Import46
Unspecified8
Import re-registration5

By drug type

Drug typeFilings
Chemical drug257
TCM177
Therapeutic biologic75
Prophylactic biologic5
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

57 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

285 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Shanghai Min Wei Bio Technology Co., Ltd. romanized1410
2F. Hoffmann-La Roche Ltd1330
3Jilin Gao Miao Pharma Co., Ltd. romanized990
4Eli Lilly and Company930
5Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized882
6Yi Chang Ren Fu Pharma Co., Ltd. romanized844
7Novo Nordisk A/S820
8Xin Da Bio Technology Co., Ltd. romanized810
9Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized760
10AstraZeneca AB740

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

135 this week

AcceptedDrugApplicants
2026/08/18Import · Class 1.1 艰难梭菌佐剂疫苗 · No verified English nameJXSL2600209 Pfizer Inc.; Pfizer Investment CO Ltd.
2026/08/18Import · Class 1 LY900043注射液 · No verified English nameJXHL2600353 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/18Import · Class 1 LY900043注射液 · No verified English nameJXHL2600352 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/18Import · Class 1 LY900043注射液 · No verified English nameJXHL2600351 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/18Import · Class 1 LY900043注射液 · No verified English nameJXHL2600350 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/18Import · Class 1 LY900043注射液 · No verified English nameJXHL2600349 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/18Import · Class 1 LY900043注射液 · No verified English nameJXHL2600348 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/18Import · Class 1 LY900043注射液 · No verified English nameJXHL2600347 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD.
2026/08/18Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2602049 Tianjin Tian Shi Li Zhi Jiao Pharma Co., Ltd. romanized
2026/08/18Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2602046 Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanized
2026/08/18Generic · Class 3 Pirfenidone TabletsCYHS2602045 Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized
2026/08/18New drug · Class 2.4 重组人血清白蛋白注射液 · No verified English nameCXSS2600127 Shenzhen Pu Luo Ji Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Pu Luo Ji Pharmaceuticals Technology Co., Ltd. romanized
2026/08/18New drug · Class 1 BC008-1A注射液 · No verified English nameCXSL2600878 Sichuan Lu Zhou Bu Zhang Biopharmaceutical Co., Ltd. romanized
2026/08/18New drug · Class 1 CG-BM1异体人骨髓间充质干细胞注射液 · No verified English nameCXSL2600877 Guangzhou Sai Juan Bio Technology Co., Ltd. romanized
2026/08/18New drug · Class 2.4 玛舒拉沙韦片 · No verified English nameCXHS2600119 Jiangxi Ke Rui Pharma Co., Ltd. romanized
2026/08/17Import · Class 1 VAY736注射液 · No verified English nameJXSL2600208 Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd.
2026/08/17Import · Class 1 ALPN-303注射液 · No verified English nameJXSL2600207 Vertex Pharmaceuticals Incorporated; Name not romanized
2026/08/17Import · Class 1 CDR132L注射液 · No verified English nameJXHL2600346 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/08/17Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2602035 Sichuan Qun Le Kang Pharma Co., Ltd. romanized; Jiangxi He Ying Pharma Co., Ltd. romanized
2026/08/17Generic · Class 3 螺内酯片 · No verified English nameCYHS2602033 Jin Wei Shi (Tianjin) Technology Co., Ltd. romanized; TIANJIN LISHENG PHARMACEUTICAL CO., LTD
2026/08/17Generic · Class 3 螺内酯片 · No verified English nameCYHS2602032 Jin Wei Shi (Tianjin) Technology Co., Ltd. romanized; TIANJIN LISHENG PHARMACEUTICAL CO., LTD
2026/08/17Generic · Class 3 Cetirizine Hydrochloride InjectionCYHS2602030 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Haerbin Yu Heng Pharmaceutical Co., Ltd. romanized
2026/08/17Generic · Class 3 Bilastine Orally disintegrating TabletsCYHS2602029 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Jilin Sheng Xi Dian Pharma Technology Development Co., Ltd. romanized
2026/08/17Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2602027 Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Yu Song Yuan Pharma Co., Ltd. romanized
2026/08/17Generic · Class 3 Indobufen TabletsCYHS2602023 Shenzhen Shi Lang Bo Biopharmaceuticals Co., Ltd. romanized; Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized
2026/08/17New drug · Class 1.1 天葛定眩颗粒 · No verified English nameCXZL2600077 Sichuan Guang Da Pharmaceutical Co., Ltd. romanized
2026/08/17New drug · Class 2.2 安尼妥单抗注射液 · No verified English nameCXSS2600126 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized; Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized
2026/08/17New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600125 Zhi Tai Pharma (Tai Zhou) Co., Ltd. romanized
2026/08/17New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600124 Zhi Tai Pharma (Tai Zhou) Co., Ltd. romanized
2026/08/17New drug · Class 1 SHR-1139注射液 · No verified English nameCXSL2600876 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized

105 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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