YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 313 drug applications between 24 November 2023 and 30 November 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 84, covering 65 drug names.

2023/11/24 – 2023/11/30

Period
2023/11/24 to 2023/11/30, 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
313
Drugs with new generic filings (by drug name, de-duplicated)
65
Accepted this week, now under review
0

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

313filings, 84 of them generic

By application type

Application typeFilings
Supplement158
Generic84
New drug44
Import19
Unspecified4
Import re-registration4

By drug type

Drug typeFilings
Chemical drug214
TCM46
Therapeutic biologic44
Prophylactic biologic7
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

65 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Tadalafil Tablets3123
2地氯雷他定口服溶液 · No verified English name3126
3Acetylcysteine Injection2253
4Cytarabine for Injection222
5Risperidone Tablets210
6布洛芬混悬滴剂 · No verified English name210
7Torsemide Injection211
8Sildenafil Citrate Tablets2112
9Flumazenil Injection212
10Amisulpride Injection211

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

203 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Sichuan Jin Xin Kang Da Pharmaceuticals Technology Co., Ltd. romanized1090
2CSL Behring GmbH710
3Chongqing Xi Er An Pharma Co., Ltd. romanized650
4Shanxi Shuang Yan Pharma Co., Ltd. romanized540
5Merck Sharp & Dohme LLC510
6Shandong Er Ye Pharmaceutical Co., Ltd. romanized510
7Hebei Wan Bang Fu Lin Pharma Co., Ltd. romanized440
8Qilu Pharmaceutical (Hainan) Co., Ltd422
9Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized333
10Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized323

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

101 this week

AcceptedDrugApplicants
2023/11/30Import · Class 1 ALXN1850注射液 · No verified English nameJXSL2300215 Alexion Pharmaceuticals Inc.; AstraZeneca Global R&D (China) Co. Ltd.
2023/11/30Import · Class 2.4 Alectinib Hydrochloride CapsulesJXHS2300109 Roche Registration GmbH; Excella GmbH & Co. KG; Chugai Pharma Manufacturing Co. Ltd.; Roche(China) Holding Ltd.
2023/11/30Generic · Class 3 Eltrombopag Lamine For Oral SuspensionCYHS2303319 Shandong Ze Zheng Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2023/11/30Generic · Class 3 Sevelamer Carbonate Powder for oral suspensionCYHS2303316 Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized
2023/11/30Generic · Class 3 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2303308 Sheng Jia (Bin Hai) Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2023/11/30Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2303307 Hefei Ke Da Bio Technology Co., Ltd. romanized; Anhui Dong Sheng You Bang Pharmaceutical Co., Ltd. romanized
2023/11/30Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2303306 Hefei Ke Da Bio Technology Co., Ltd. romanized; Anhui Dong Sheng You Bang Pharmaceutical Co., Ltd. romanized
2023/11/30Generic · Class 3 Potassium Phosphates InjectionCYHS2303305 Jiangxi Bo Tai Pharma Co., Ltd. romanized; Jiangxi Dong Fu Pharmaceutical Co., Ltd. romanized
2023/11/30Generic · Class 3 Thioctic Acid TabletsCYHS2303304 Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized
2023/11/30Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2303303 Hefei Ke Da Bio Technology Co., Ltd. romanized; Anhui Dong Sheng You Bang Pharmaceutical Co., Ltd. romanized
2023/11/30Generic · Class 3 Thioctic Acid TabletsCYHS2303302 Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized
2023/11/30New drug · Class 1 菲诺利单抗注射液 · No verified English nameCXSS2300088 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2023/11/30New drug · Class 1 JWK001注射液 · No verified English nameCXSL2300827 Chengdu Jin Wei Ke Bio Technology Co., Ltd. romanized
2023/11/30New drug · Class 1 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2300826 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2023/11/30New drug · Class 1 IUAb190708注射液 · No verified English nameCXSL2300825 Ying Nuo Ou Qi Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2023/11/30New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2300824 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2023/11/30New drug · Class 1 SHR0302片 · No verified English nameCXHS2300108 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/11/30New drug · Class 1 氘恩扎鲁胺软胶囊 · No verified English nameCXHS2300107 Hai Chuang Pharma Co., Ltd. romanized; Ren Fu Pu Ke Pharma (Wuhan) Co., Ltd. romanized
2023/11/30New drug · Class 2.4 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2301323 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2023/11/30New drug · Class 2.2 JW202232吸入气雾剂 · No verified English nameCXHL2301322 Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized
2023/11/30New drug · Class 2.2 JW202232吸入气雾剂 · No verified English nameCXHL2301321 Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized
2023/11/30New drug · Class 2.3 CP006吸入粉雾剂 · No verified English nameCXHL2301320 Shanghai Xin Huang He Pharmaceutical Co., Ltd. romanized
2023/11/30New drug · Class 2.2 JW202232吸入气雾剂 · No verified English nameCXHL2301319 Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized
2023/11/30New drug · Class 2.2 LN2201片 · No verified English nameCXHL2301318 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2023/11/30New drug · Class 2.2 LN2201片 · No verified English nameCXHL2301317 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2023/11/30New drug · Class 2.2 LN2201片 · No verified English nameCXHL2301316 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2023/11/29Generic · Class 3 Acetylcysteine InjectionCYHS2303299 Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.
2023/11/29Generic · Class 3 Salbutamol Sulfate injectionCYHS2303298 Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/11/29Generic · Class 3 Gatifloxacin Eye DropsCYHS2303293 Guangzhou Ren Heng Pharmaceuticals Technology Co., Ltd. romanized; Hefei Hua Wei Pharma Co., Ltd. romanized
2023/11/29Generic · Class 3 Calcium Gluconate in Sodium Chloride InjectionCYHS2303292 Shijiazhuang No.4 Pharmaceutical Co., Ltd.

71 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.