YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 431 drug applications between 9 June 2026 and 15 June 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 77, covering 53 drug names.

2026/06/09 – 2026/06/15

Period
2026/06/09 to 2026/06/15, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
431
Drugs with new generic filings (by drug name, de-duplicated)
53
Accepted this week, now under review
128

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

431filings, 77 of them generic

By application type

Application typeFilings
Supplement268
Generic77
New drug63
Import16
Import re-registration4
Unspecified3

By drug type

Drug typeFilings
Chemical drug229
TCM145
Therapeutic biologic55
Prophylactic 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

53 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

258 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company830
2Pfizer Inc.630
3Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized623
4Amgen Inc.610
5Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized550
6Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized550
7Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized520
8Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
9Bao Tou Zhong Yao Co., Ltd. romanized440
10Beijing Tong Ren Tang Pharmaceutical 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

108 this week

AcceptedDrugApplicants
2026/06/15Generic · Class 3 Metoprolol Succinate Extended-release CapsulesCYHS2601415 Shandong Hua Su Pharmaceutical Co., Ltd. romanized
2026/06/15Generic · Class 3 Metoprolol Succinate Extended-release CapsulesCYHS2601414 Shandong Hua Su Pharmaceutical Co., Ltd. romanized
2026/06/15Generic · Class 3 Vitamin K1 InjectionCYHS2601413 Shenzhen Xin Qi Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2026/06/15Generic · Class 3 头孢克肟胶囊 · No verified English nameCYHS2601412 Hunan Zhuang Yuan Pharmaceutical Co., Ltd. romanized; Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized
2026/06/15Generic · Class 3 盐酸甲氧氯普胺口服溶液 · No verified English nameCYHS2601409 Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized
2026/06/15Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601408 Chengdu Easton Biopharmaceuticals Co.,Ltd.; Chengdu Tong De Pharma Co., Ltd. romanized
2026/06/15New drug · Class 1 注射用AMT-116 · No verified English nameCXSL2600638 Pu Zhong Fa Xian Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/06/15New drug · Class 1 注射用HY07121(皮下注射) · No verified English nameCXSL2600637 Name not romanized
2026/06/15New drug · Class 1 BG-75202片 · No verified English nameCXHL2600714 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/06/15New drug · Class 1 BG-75202片 · No verified English nameCXHL2600713 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/06/15New drug · Class 1 BG-75202片 · No verified English nameCXHL2600712 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2026/06/15New drug · Class 1 FXR0906注射液 · No verified English nameCXHL2600711 Fu Xing Pharmaceuticals Industry Development (Shenzhen) Co., Ltd. romanized
2026/06/12Import · Class 1 AZD2936 · No verified English nameJXSL2600141 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/06/12Import · Class 2.4 BMS-986510胶囊 · No verified English nameJXHL2600218 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/06/12Import · Class 2.4 BMS-986510胶囊 · No verified English nameJXHL2600217 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/06/12Import · Class 2.4 BMS-986510胶囊 · No verified English nameJXHL2600216 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/06/12Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601406 Chongqing Huapont Pharmaceutical Co., Ltd.
2026/06/12Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2601405 Chongqing Huapont Pharmaceutical Co., Ltd.
2026/06/12Generic · Class 3 Cyclophosphamide InjectionCYHS2601403 Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized
2026/06/12Generic · Class 3 Minoxidil LinimentCYHS2601401 Hubei Kang Zheng Pharma Co., Ltd. romanized
2026/06/12Generic · Class 3 Minoxidil LinimentCYHS2601400 Hubei Kang Zheng Pharma Co., Ltd. romanized
2026/06/12Generic · Class 3 Cetirizine Hydrochloride InjectionCYHS2601399 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2026/06/12New drug · Class 2.2 皮内注射用重组卡介苗 · No verified English nameCXSL2600636 Chengdu An Yong Ding Ye Bio Technology Co., Ltd. romanized
2026/06/12New drug · Class 1 重组抗IL-4Rα人源化单克隆抗体注射液 · No verified English nameCXSL2600635 San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized
2026/06/12New drug · Class 1 AZD5863 · No verified English nameCXSL2600634 A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized
2026/06/12New drug · Class 1 GC012F注射液 · No verified English nameCXSL2600633 Gen Xi Bio Technology (Shanghai) Co., Ltd. romanized; A Si Li Kang Investment (Zhongguo) Co., Ltd. romanized; Suzhou Gen Xi Bio Technology Co., Ltd. romanized
2026/06/12New drug · Class 1 注射用Efimosfermin alfa · No verified English nameCXSL2600632 Ge Lan Su Shi Ke (Zhongguo) Investment Co., Ltd. romanized
2026/06/12New drug · Class 1 IBI3040 · No verified English nameCXHL2600710 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/06/12New drug · Class 1 IBI3032 · No verified English nameCXHL2600709 Xin Da Bio Technology Co., Ltd. romanized
2026/06/12New drug · Class 1 IBI3032 · No verified English nameCXHL2600708 Xin Da Bio Technology Co., Ltd. romanized

78 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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