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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 392 drug applications between 28 October 2026 and 3 November 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 40 drug names.

2026/10/28 – 2026/11/03

Period
2026/10/28 to 2026/11/03, 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
392
Drugs with new generic filings (by drug name, de-duplicated)
40
Accepted this week, now under review
392

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

392filings, 57 of them generic

By application type

Application typeFilings
Supplement196
New drug97
Generic57
Import29
Import re-registration11
Unspecified2

By drug type

Drug typeFilings
Chemical drug186
TCM121
Therapeutic biologic81
Prophylactic biologic4

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

40 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1氟比洛芬凝胶贴膏 · No verified English name3316
2氧 · No verified English name3315
3Vortioxetine Hydrobromide Tablets3110
4Oseltamivir Phosphate Capsules3139
5Polidocanol Injection3123
6Emedastine Difumarate Eye Drops229
7环孢素滴眼液(Ⅲ) · No verified English name229
8Ezetimibe and Atorvastatin Calcium Trihydrate Tablets214
9复方氨基酸注射液(17AA-SF) · No verified English name214
10复方电解质维持液 · No verified English name212

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

226 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB1050
2Eli Lilly and Company910
3Sichuan Xin Da Kang Pharma Co., Ltd. romanized770
4Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized760
5Fresenius Kabi AB720
6Hebei Wan Sui Pharma Co., Ltd. romanized660
7Sichuan Qi Li Pharmaceutical Co., Ltd. romanized650
8MUNDIPHARMA GmbH610
9Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized610
10Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized532

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

Entered review this week
372
Left the under-review list this week
401

Of these, NMPA published approval-document delivery for 176 (including 172 supplemental applications, not counted as new marketing approvals) and notification delivery for 8; the outcome of the other 217 is to be checked.

Most filings leaving review, by company

Most filings leaving review, by company
#Company (first applicant)FilingsDrugs
1Novo Nordisk A/S152
2Shanghai Min Wei Bio Technology Co., Ltd. romanized111
3Beijing Bao Shu Tang Technology Pharma Co., Ltd. romanized1010
4Eli Lilly Nederland B.V.82
5Xin Da Bio Technology Co., Ltd. romanized81
6Hainan Ai Ke Pharmaceutical Co., Ltd. romanized55
7Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized55
8Pfizer Europe MA EEIG53
9Shijiazhuang No.4 Pharmaceutical Co., Ltd.44
10Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized42

Most filings entering review, by company

Most filings entering review, by company
#Company (first applicant)FilingsDrugs
1Eli Lilly and Company91
2Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized73
3Fresenius Kabi AB72
4Hebei Wan Sui Pharma Co., Ltd. romanized66
5Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized66
6Sichuan Qi Li Pharmaceutical Co., Ltd. romanized65
7MUNDIPHARMA GmbH61
8Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized61
9AstraZeneca AB53
10Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized53

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

139 this week

AcceptedDrugApplicants
2026/11/03Import · Class 1 AZD0486 · No verified English nameJXSL2600294 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/11/03Import · Class 1 AZD0486 · No verified English nameJXSL2600293 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/11/03Import · Class 1 AZD5492 · No verified English nameJXSL2600292 AstraZeneca AB; AstraZeneca Global ll&U (China) Co. Ltd.
2026/11/03Import · Class 1 AZD3470薄膜衣片 · No verified English nameJXHL2600482 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/11/03Import · Class 1 AZD3470薄膜衣片 · No verified English nameJXHL2600481 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/11/03Generic · Class 3 Pregabalin Extended release TabletsCYHS2602684 Chongqing De Run Sheng Pharmaceuticals Co., Ltd. romanized; Chongqing Huapont Pharmaceutical Co., Ltd.
2026/11/03Generic · Class 3 Pioglitazone and Metformin Hydrochloride TabletsCYHS2602682 Zhengzhou Tai Feng Pharmaceutical Co., Ltd. romanized
2026/11/03Generic · Class 3 对乙酰氨基酚颗粒 · No verified English nameCYHS2602680 Shijiazhuang Gree Pharmaceutical Co., Ltd
2026/11/03Generic · Class 3 对乙酰氨基酚颗粒 · No verified English nameCYHS2602679 Shijiazhuang Gree Pharmaceutical Co., Ltd
2026/11/03New drug · Class 1.1 芩椒颗粒 · No verified English nameCXZL2600112 Sichuan Ji Sheng Tang Pharma Co., Ltd. romanized
2026/11/03New drug · Class 1.1 七妙颗粒 · No verified English nameCXZL2600111 Nanjing Rong Yu Pharmaceuticals Industry Co., Ltd. romanized; Nanjing Zhong Pharmaceuticals University romanized
2026/11/03New drug · Class 1 奥美妥塔单抗注射液 · No verified English nameCXSS2600184 Jiangsu Ao Sai Kang Biopharmaceuticals Co., Ltd. romanized; Yan Tai Mai Bai Rui International Biopharmaceuticals Co., Ltd. romanized
2026/11/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600183 Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized; Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized
2026/11/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600182 Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized; Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized
2026/11/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600181 Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized; Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized
2026/11/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600180 Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized; Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized
2026/11/03New drug · Class 3.3 司美格鲁肽注射液 · No verified English nameCXSS2600179 Zhuhai Lian Bang Biopharmaceuticals Co., Ltd. romanized; Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized
2026/11/03New drug · Class 1 KSD-101注射液 · No verified English nameCXSL2601217 Shanghai Heng Sai Bio Technology Co., Ltd. romanized
2026/11/03New drug · Class 1 BNT326 · No verified English nameCXSL2601216 Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized; Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized
2026/11/03New drug · Class 1 Gotistobart注射液 · No verified English nameCXSL2601215 Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/11/03New drug · Class 1 SHR-4610注射液 · No verified English nameCXSL2601214 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/11/03New drug · Class 1 SYS6043 · No verified English nameCXSL2601213 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/11/03New drug · Class 2.2 注射用瑞康曲妥珠单抗 · No verified English nameCXSL2601212 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/11/03New drug · Class 1 CC312冻干粉针剂 · No verified English nameCXSL2601211 Hui He Bio Technology (Shanghai) Co., Ltd. romanized
2026/11/03New drug · Class 1 UMSC01细胞注射液 · No verified English nameCXSL2601210 Shanghai Jiu Qian Cheng Biopharmaceuticals Co., Ltd. romanized
2026/11/03New drug · Class 1 SHR-5439注射液 · No verified English nameCXSL2601209 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/11/03New drug · Class 1 SHR-4610注射液 · No verified English nameCXSL2601208 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/11/03New drug · Class 1 注射用HS-20122 · No verified English nameCXSL2601207 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/11/03New drug · Class 1 普美昔替尼鼻喷雾剂 · No verified English nameCXHS2600146 Beijing Pu Qi Pharmaceuticals Technology Co., Ltd. romanized; Chi Feng Sai Lin Tai Pharma Co., Ltd. romanized
2026/11/03New drug · Class 1 IMP9064片 · No verified English nameCXHL2601356 Nanjing Ying Pai Pharma Co., Ltd. romanized

109 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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