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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 416 drug applications between 5 September 2026 and 11 September 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 65, covering 51 drug names.

2026/09/05 – 2026/09/11

Period
2026/09/05 to 2026/09/11, 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
416
Drugs with new generic filings (by drug name, de-duplicated)
51
Accepted this week, now under review
351

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

416filings, 65 of them generic

By application type

Application typeFilings
Supplement256
New drug78
Generic65
Import11
Import re-registration4
Unspecified2

By drug type

Drug typeFilings
Chemical drug178
TCM149
Therapeutic biologic82
Prophylactic biologic4
Biologic2
In vitro diagnostic reagent1

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

#DrugNew generic filingsFiling companiesUnder review, all years
1Sodium Bicarbonate Injection3210
2Oseltamivir Phosphate Capsules3239
3富马酸奥赛利定注射液 · No verified English name313
4Dotinurad Tablets2155
5Vonoprazan Fumarate Tablets2160
6Nilotinib Capsules216
7Ticagrelor Tablets2110
8Ambroxol Hydrochloride Oral Solution2146
9Fexofenadine Hydrochloride Tablets2110
10Ziprasidone Hydrochloride Capsules219

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

255 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized13130
2Shaanxi Hua Xi Pharmaceutical Co., Ltd. romanized990
3Beijing Kang Nuo Ya Biopharmaceuticals Co., Ltd. romanized810
4Shaanxi Ou Ke Pharma Co., Ltd. romanized660
5Bo Hui Biopharmaceutical (Yunnan) Co., Ltd. romanized650
6Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized620
7Shenzhen Han Yu Pharma Co., Ltd. romanized610
8Jiangxi Hua Tai Pharma Co., Ltd. romanized550
9Henan Bai Nian Kang Xin Pharma Co., Ltd. romanized550
10Jilin Yu Ren 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

111 this week

AcceptedDrugApplicants
2026/09/11Import · Class 1 LY4405094注射液 · No verified English nameJXSL2600242 Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD
2026/09/11Import · Class 2.2 乌帕替尼口服溶液 · No verified English nameJXHL2600401 AbbVie Inc.; AbbVie Pharmaceutical Trading(Shanghai) Co. Ltd.
2026/09/11Import · Class 2.4 Upadacitinib Sustained-release TabletsJXHL2600400 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/09/11Generic · Class 3 Nafamostat Mesilate for InjectionCYHS2602272 Wuhan Hua Long Biopharmaceutical Co., Ltd. romanized
2026/09/11Generic · Class 3 Netilmicin Sulfate InjectionCYHS2602268 Chengdu Brilliant Pharmaceutical Co., Ltd.
2026/09/11New drug · Class 3.1 温胆汤颗粒 · No verified English nameCXZS2600049 Hainan Si Da Pharmaceutical Co., Ltd. romanized; Anhui Hong Xin Pharma Development Co., Ltd. romanized
2026/09/11New drug · Class 1.1 夏黄颗粒 · No verified English nameCXZL2600090 Yi You Bio (Shanghai) Co., Ltd. romanized; Meng Yang Pharma (Shanghai) Co., Ltd. romanized
2026/09/11New drug · Class 1 注射用TQB2102 · No verified English nameCXSS2600150 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized; Name not romanized
2026/09/11New drug · Class 1 TQH2722注射液 · No verified English nameCXSS2600149 Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/09/11New drug · Class 3.3 地舒单抗注射液 · No verified English nameCXSS2600148 Fu Xing Han Lin (Shenzhen) Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized
2026/09/11New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2600995 An Ming Kang Yuan Pharmaceutical (Jilin) Co., Ltd. romanized; An Kang Yuan Bio Technology (Jilin) Co., Ltd. romanized
2026/09/11New drug · Class 1 注射用SHR-1219 · No verified English nameCXSL2600994 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/09/11New drug · Class 1 SYS6065 · No verified English nameCXSL2600993 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/09/11New drug · Class 1 JY2002注射液 · No verified English nameCXSL2600992 Jiangsu Ji Ye Biopharmaceutical Co., Ltd. romanized; Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized
2026/09/11New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2600991 Jiangsu Sai Yi Bio Technology Co., Ltd. romanized
2026/09/11New drug · Class 1 IBI354 · No verified English nameCXSL2600990 Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2026/09/11New drug · Class 1 BL0175注射液 · No verified English nameCXHL2601109 Shanghai Bi Ling Bio Technology Co., Ltd. romanized
2026/09/11New drug · Class 1 HTD1801胶囊 · No verified English nameCXHL2601108 Shanghai Fu Yao Bio Technology Co., Ltd. romanized; Zhongguo Yi Xue Ke College Pharmaceuticals Bio Technology Research Institute romanized
2026/09/10Import · Class 2.1; 2.2 索特西普注射液 · No verified English nameJXSL2600241 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd.
2026/09/10Import · Class 1 NCX 470滴眼液 · No verified English nameJXHS2600105 OCUMENSION(HONG KONG)LIMITED; Alliance Medical Products Inc. (dba. Siegfried Irvine); Ocumension Therapeutics(Suzhou)Co. Ltd.
2026/09/10Generic · Class 3 Bilastine Oral SolutionCYHS2602267 Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized
2026/09/10Generic · Class 3 盐酸奥洛他定口崩片 · No verified English nameCYHS2602266 Hong Yue Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Hao Ge Pharma Co., Ltd. romanized
2026/09/10Generic · Class 3 Vardenafil Hydrochloride Orally disintegrating TabletsCYHS2602261 Beijing Ming Ze Zhong He Drug Research Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/09/10New drug · Class 3.1 温胆汤颗粒 · No verified English nameCXZS2600048 China Resources Sanjiu Medical & Pharmaceutical Co.,Ltd.
2026/09/10New drug · Class 1.3 三价流感重组蛋白疫苗 · No verified English nameCXSL2600989 Zhuhai Shi Li Zhu Dan Kang Bio Technology Co., Ltd. romanized
2026/09/10New drug · Class 1.3 三价流感重组蛋白疫苗 · No verified English nameCXSL2600988 Zhuhai Shi Li Zhu Dan Kang Bio Technology Co., Ltd. romanized
2026/09/10New drug · Class 1 HLX109注射液 · No verified English nameCXSL2600987 Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized; Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized
2026/09/10New drug · Class 1 KHN923注射液 · No verified English nameCXSL2600986 Chengdu Kang Hong Bio Technology Co., Ltd. romanized
2026/09/10New drug · Class 1 MTS109注射液 · No verified English nameCXSL2600985 Ji Tai Technology (Beijing) Co., Ltd. romanized; Beijing Ji Tai Sheng Ming Technology Co., Ltd. romanized
2026/09/10New drug · Class 1 INT-1868片 · No verified English nameCXHL2601107 Yi Kun Xing Jian Biopharmaceuticals (Shanghai) Co., Ltd. romanized

81 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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