YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 368 drug applications between 27 October 2026 and 2 November 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 52, covering 38 drug names.
2026/10/27 – 2026/11/02
- New acceptances this week
- 368
- Drugs with new generic filings (by drug name, de-duplicated)
- 38
- Accepted this week, now under review
- 368
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
368filings, 52 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 195 |
| New drug | 79 |
| Generic | 52 |
| Import | 31 |
| Import re-registration | 9 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 181 |
| TCM | 110 |
| Therapeutic biologic | 72 |
| Prophylactic biologic | 5 |
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
38 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 氧 · No verified English name | 3 | 3 | 15 |
| 2 | Vortioxetine Hydrobromide Tablets | 3 | 1 | 10 |
| 3 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 4 | Polidocanol Injection | 3 | 1 | 23 |
| 5 | Emedastine Difumarate Eye Drops | 2 | 2 | 9 |
| 6 | 氟比洛芬凝胶贴膏 · No verified English name | 2 | 2 | 16 |
| 7 | Ezetimibe and Atorvastatin Calcium Trihydrate Tablets | 2 | 1 | 4 |
| 8 | 复方氨基酸注射液(17AA-SF) · No verified English name | 2 | 1 | 4 |
| 9 | 复方电解质维持液 · No verified English name | 2 | 1 | 2 |
| 10 | 帕拉米韦氯化钠注射液 · No verified English name | 2 | 1 | 17 |
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
210 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 9 | 1 | 0 |
| 2 | Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized | 7 | 3 | 0 |
| 3 | Fresenius Kabi AB | 7 | 2 | 0 |
| 4 | Hebei Wan Sui Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Sichuan Qi Li Pharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 7 | MUNDIPHARMA GmbH | 6 | 1 | 0 |
| 8 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized | 6 | 1 | 0 |
| 9 | AstraZeneca AB | 5 | 3 | 0 |
| 10 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 3 | 2 |
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
- 346
- Left the under-review list this week
- 330
Of these, NMPA published approval-document delivery for 100 (including 96 supplemental applications, not counted as new marketing approvals) and notification delivery for 5; the outcome of the other 225 is to be checked.
Most filings leaving review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Novo Nordisk A/S | 15 | 2 |
| 2 | Shanghai Min Wei Bio Technology Co., Ltd. romanized | 11 | 1 |
| 3 | Eli Lilly Nederland B.V. | 8 | 2 |
| 4 | Xin Da Bio Technology Co., Ltd. romanized | 8 | 1 |
| 5 | Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized | 5 | 5 |
| 6 | Beijing Xian Sheng Xiang Rui Bio Zhi Pin Co., Ltd. romanized | 5 | 2 |
| 7 | Novartis Europharm Limited | 4 | 2 |
| 8 | Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized | 4 | 2 |
| 9 | Jiangsu En Hua Pharma Co., Ltd. romanized | 4 | 2 |
| 10 | Sanofi-Aventis Recherche & Développement | 3 | 3 |
Most filings entering review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Eli Lilly and Company | 9 | 1 |
| 2 | Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized | 7 | 3 |
| 3 | Fresenius Kabi AB | 7 | 2 |
| 4 | Sichuan Qi Li Pharmaceutical Co., Ltd. romanized | 6 | 5 |
| 5 | MUNDIPHARMA GmbH | 6 | 1 |
| 6 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized | 6 | 1 |
| 7 | AstraZeneca AB | 5 | 3 |
| 8 | Merck Europe B.V. | 5 | 3 |
| 9 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 |
| 10 | Bard Pharmaceuticals Limited | 4 | 4 |
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
117 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/11/02Import · Class 1 | Tilrekimig注射液 · No verified English nameJXSL2600291 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2026/11/02Import · Class 1 | NVG-2089注射液 · No verified English nameJXSL2600290 | Nuvig Therapeutics Inc.; Arcos Bio (Shanghai) Co. Ltd. |
| 2026/11/02Generic · Class 3 | 碘解磷定注射液 · No verified English nameCYHS2602678 | Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2026/11/02Generic · Class 3 | Paracetamol TabletsCYHS2602673 | Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized |
| 2026/11/02Generic · Class 3 | Ferrous Succinate TabletsCYHS2602669 | Chengdu Ke Lai Meng Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2026/11/02New drug · Class 3.2 | 注射用A型肉毒毒素 · No verified English nameCXSS2600178 | Lanzhou Bio Technology Kai Fa Co., Ltd. romanized |
| 2026/11/02New drug · Class 3.2 | 注射用A型肉毒毒素 · No verified English nameCXSS2600177 | Lanzhou Bio Technology Kai Fa Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | SHR-4610注射液 · No verified English nameCXSL2601206 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2601205 | Guangdong Heng Qin Joint Sheng Ming Ke Xue Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | SPGL008注射液 · No verified English nameCXSL2601204 | Shenzhen Sai Bao Er Bio Pharma Co., Ltd. romanized |
| 2026/11/02New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2601203 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/11/02New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2601202 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | 注射用FH-006 · No verified English nameCXSL2601201 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Fu Hong Biopharmaceuticals Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | 注射用TQB2102 · No verified English nameCXSL2601200 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2026/11/02New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2601199 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | 注射用SHR-1826 · No verified English nameCXSL2601198 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | SHR-4375注射液 · No verified English nameCXSL2601197 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | 注射用HS-20093 · No verified English nameCXSL2601196 | Changzhou Heng Bang Pharma Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | 注射用SHR-9839(sc) · No verified English nameCXSL2601195 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/11/02New drug · Class 1.1 | 重组金黄色葡萄球菌疫苗(大肠杆菌) · No verified English nameCXSL2601194 | Chengdu Ou Lin Bio Technology Co., Ltd. romanized; Chongqing Yuan Lun Bio Technology Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | 注射用HBT-708 · No verified English nameCXSL2601193 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | WTX-212C自体工程化红细胞注射液 · No verified English nameCXSL2601192 | Xi Hu Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | 卡维列隆氨丁三醇片 · No verified English nameCXHS2600145 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | 卡维列隆氨丁三醇片 · No verified English nameCXHS2600144 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | 卡维列隆氨丁三醇片 · No verified English nameCXHS2600143 | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | HRS-6093片 · No verified English nameCXHL2601349 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | HRS-6093片 · No verified English nameCXHL2601348 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | HRS-7058胶囊 · No verified English nameCXHL2601347 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | HRS-7058胶囊 · No verified English nameCXHL2601346 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/11/02New drug · Class 1 | HRS-2329片 · No verified English nameCXHL2601345 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
87 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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