YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 342 drug applications between 25 October 2026 and 31 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 40 drug names.
2026/10/25 – 2026/10/31
- New acceptances this week
- 342
- Drugs with new generic filings (by drug name, de-duplicated)
- 40
- Accepted this week, now under review
- 340
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
342filings, 60 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 189 |
| Generic | 60 |
| New drug | 47 |
| Import | 35 |
| Import re-registration | 10 |
| Unspecified | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 171 |
| TCM | 97 |
| Therapeutic biologic | 68 |
| Prophylactic biologic | 5 |
| Biologic | 1 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ruxolitinib Phosphate Tablets | 4 | 2 | 27 |
| 2 | 氧 · No verified English name | 3 | 3 | 15 |
| 3 | Vortioxetine Hydrobromide Tablets | 3 | 1 | 10 |
| 4 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 5 | Polidocanol Injection | 3 | 1 | 23 |
| 6 | Suvorexant Tablets | 3 | 1 | 3 |
| 7 | 氟比洛芬凝胶贴膏 · No verified English name | 2 | 2 | 16 |
| 8 | Ezetimibe and Atorvastatin Calcium Trihydrate Tablets | 2 | 1 | 4 |
| 9 | 复方氨基酸注射液(17AA-SF) · No verified English name | 2 | 1 | 4 |
| 10 | 复方电解质维持液 · No verified English name | 2 | 1 | 2 |
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
207 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 | Sichuan Qi Li Pharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 5 | MUNDIPHARMA GmbH | 6 | 1 | 0 |
| 6 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | AstraZeneca AB | 5 | 3 | 0 |
| 8 | Merck Europe B.V. | 5 | 3 | 0 |
| 9 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 10 | Bard Pharmaceuticals Limited | 4 | 4 | 0 |
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
- 376
Of these, NMPA published approval-document delivery for 100 (including 95 supplemental applications, not counted as new marketing approvals) and notification delivery for 3; the outcome of the other 273 is to be checked.
Most filings leaving review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Shanghai Min Wei Bio Technology Co., Ltd. romanized | 14 | 1 |
| 2 | Novo Nordisk A/S | 9 | 3 |
| 3 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 9 | 3 |
| 4 | AstraZeneca AB | 8 | 3 |
| 5 | Xin Da Bio Technology Co., Ltd. romanized | 8 | 1 |
| 6 | Eli Lilly Nederland B.V. | 6 | 1 |
| 7 | Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized | 5 | 5 |
| 8 | Beijing Xian Sheng Xiang Rui Bio Zhi Pin Co., Ltd. romanized | 5 | 2 |
| 9 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized | 5 | 2 |
| 10 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 5 | 2 |
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
90 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/10/30Import · Class 2.2 | 特泽利尤单抗注射液 · No verified English nameJXSS2600101 | AstraZeneca AB; Amgen Manufacturing Limited LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2026/10/30Import · Class 2.2 | 特泽利尤单抗注射液 · No verified English nameJXSS2600100 | AstraZeneca AB; Amgen Manufacturing Limited LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2026/10/30Import · Class 1 | LY4086940片 · No verified English nameJXHL2600479 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/10/30Import · Class 1 | LY4086940片 · No verified English nameJXHL2600478 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/10/30Import · Class 1 | LY4086940片 · No verified English nameJXHL2600477 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/10/30Import · Class 1 | LY4086940片 · No verified English nameJXHL2600476 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/10/30Import · Class 1 | LY4086940片 · No verified English nameJXHL2600475 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/10/30Import · Class 1 | LY4086940片 · No verified English nameJXHL2600474 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/10/30Import · Class 1 | LY4086940片 · No verified English nameJXHL2600473 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/10/30Import · Class 1 | LY4086940片 · No verified English nameJXHL2600472 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/10/30Import · Class 1 | LY4086940片 · No verified English nameJXHL2600471 | Eli Lilly and Company; LILLY (BEIJING) MEDICAL TECHNOLOGY INNOVATION CO. LTD. |
| 2026/10/30Generic · Class 3 | Ketotifen Fumarate Oral SolutionCYHS2602662 | Da Lian Bai Li Tian Hua Pharmaceutical Co., Ltd. romanized; Henan Hua Luo Kang Run Pharma Co., Ltd. romanized |
| 2026/10/30Generic · Class 3 | 复方氨基酸注射液(17AA-SF) · No verified English nameCYHS2602661 | Yuan Da Yi Xue Ying Yang Ke Xue (Wuhan) Co., Ltd. romanized |
| 2026/10/30Generic · Class 3 | 复方氨基酸注射液(17AA-SF) · No verified English nameCYHS2602660 | Yuan Da Yi Xue Ying Yang Ke Xue (Wuhan) Co., Ltd. romanized |
| 2026/10/30Generic · Class 3 | Pirfenidone TabletsCYHS2602658 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2026/10/30New drug · Class 3.1 | 三痹汤颗粒 · No verified English nameCXZS2600059 | Guangxi Zhong Pharmaceuticals University Bai Nian Le Pharmaceutical Co., Ltd. romanized |
| 2026/10/30New drug · Class 3.1 | 蠲痹汤颗粒 · No verified English nameCXZS2600058 | Guangxi Zhong Pharmaceuticals University Bai Nian Le Pharmaceutical Co., Ltd. romanized |
| 2026/10/30New drug · Class 1 | 注射用MHB039A · No verified English nameCXSL2601191 | Ming Hui Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/10/30New drug · Class 1 | 注射用MHB046C · No verified English nameCXSL2601190 | Ming Hui Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2026/10/30New drug · Class 1 | HRS-4642注射液 · No verified English nameCXHL2601331 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/10/29Import · Class 2.4 | Seladelpar胶囊 · No verified English nameJXHL2600470 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/10/29Import · Class 1 | Cilofexor片 · No verified English nameJXHL2600469 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/10/29Import · Class 1 | Cilofexor片 · No verified English nameJXHL2600468 | Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd. |
| 2026/10/29Import · Class 1 | Casdatifan 片 · No verified English nameJXHL2600467 | Arcus Biosciences Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd. |
| 2026/10/29Import · Class 1 | Casdatifan 片 · No verified English nameJXHL2600466 | Arcus Biosciences Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd. |
| 2026/10/29Generic · Class 3 | 硫酸锌注射液 · No verified English nameCYHS2602647 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2026/10/29Generic · Class 3 | Alendronate Sodium Oral SolutionCYHS2602641 | Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized |
| 2026/10/29New drug · Class 2.2; 2.3 | 小儿清热消炎宁颗粒 · No verified English nameCXZS2600057 | Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized |
| 2026/10/29New drug · Class 3.3 | 度拉糖肽注射液 · No verified English nameCXSS2600176 | Le Pu Pharma Co., Ltd. romanized; Le Pu (Beijing) Bio Technology Co., Ltd. romanized |
| 2026/10/29New drug · Class 3.3 | 度拉糖肽注射液 · No verified English nameCXSS2600175 | Le Pu Pharma Co., Ltd. romanized; Le Pu (Beijing) Bio Technology Co., Ltd. romanized |
60 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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