YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 382 drug applications between 23 October 2026 and 29 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 42 drug names.
2026/10/23 – 2026/10/29
- New acceptances this week
- 382
- Drugs with new generic filings (by drug name, de-duplicated)
- 42
- Accepted this week, now under review
- 375
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
382filings, 60 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 226 |
| Generic | 60 |
| New drug | 53 |
| Import | 34 |
| Import re-registration | 6 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 175 |
| TCM | 115 |
| Therapeutic biologic | 82 |
| Biologic | 5 |
| 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
42 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 | Vortioxetine Hydrobromide Tablets | 3 | 1 | 10 |
| 3 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 4 | Polidocanol Injection | 3 | 1 | 23 |
| 5 | Suvorexant Tablets | 3 | 1 | 3 |
| 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 | 复方电解质维持液 · No verified English name | 2 | 1 | 2 |
| 9 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 10 | 苯磺酸美洛加巴林口崩片 · 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
236 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized | 7 | 3 | 0 |
| 2 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized | 6 | 1 | 0 |
| 3 | Sichuan Qi Li Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 4 | Merck Europe B.V. | 5 | 3 | 0 |
| 5 | AstraZeneca AB | 5 | 2 | 0 |
| 6 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Bard Pharmaceuticals Limited | 4 | 4 | 0 |
| 8 | Guangxi Wan Tong Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 4 | 4 | 0 |
| 10 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized | 4 | 3 | 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
- 349
- Left the under-review list this week
- 480
Of these, NMPA published approval-document delivery for 110 (including 104 supplemental applications, not counted as new marketing approvals) and notification delivery for 4; the outcome of the other 366 is to be checked.
Most filings leaving review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Eli Lilly and Company | 14 | 4 |
| 2 | Novo Nordisk A/S | 14 | 4 |
| 3 | Shanghai Min Wei Bio Technology Co., Ltd. romanized | 14 | 1 |
| 4 | F. Hoffmann-La Roche Ltd | 13 | 3 |
| 5 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 9 | 6 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 9 | 3 |
| 7 | Xin Da Bio Technology Co., Ltd. romanized | 8 | 1 |
| 8 | AstraZeneca AB | 7 | 3 |
| 9 | Novartis Pharma AG | 6 | 5 |
| 10 | Sanofi-Aventis Recherche & Développement | 6 | 5 |
Most filings entering review, by company
| # | Company (first applicant) | Filings | Drugs |
|---|---|---|---|
| 1 | Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized | 7 | 3 |
| 2 | Merck Europe B.V. | 5 | 3 |
| 3 | AstraZeneca AB | 5 | 2 |
| 4 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized | 5 | 1 |
| 5 | Bard Pharmaceuticals Limited | 4 | 4 |
| 6 | Guangxi Wan Tong Pharmaceutical Co., Ltd. romanized | 4 | 4 |
| 7 | Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized | 4 | 4 |
| 8 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized | 4 | 3 |
| 9 | Topfond Pharmaceutical Co., Ltd. | 4 | 3 |
| 10 | Novo Nordisk A/S | 4 | 2 |
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 |
|---|---|---|
| 2026/10/29Import · 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 |
| 2026/10/29New drug · Class 1 | Pumitamig注射液 · No verified English nameCXSL2601189 | Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized |
| 2026/10/29New drug · Class 1 | QI-019D注射液 · No verified English nameCXSL2601188 | Qi Han (Shanghai) Bio Technology Co., Ltd. romanized |
| 2026/10/29New drug · Class 1 | 注射用重组人源化抗BCMA/CD3双特异性抗体 · No verified English nameCXSL2601187 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2026/10/29New drug · Class 1 | 注射用重组人源化抗BCMA/CD3双特异性抗体 · No verified English nameCXSL2601186 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2026/10/29New drug · Class 1 | RGT-274-CR片 · No verified English nameCXHL2601330 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2026/10/29New drug · Class 1 | RGT-274-CR片 · No verified English nameCXHL2601329 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2026/10/29New drug · Class 1 | RGT-274-CR片 · No verified English nameCXHL2601328 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2026/10/29New drug · Class 1 | RGT-274-CR片 · No verified English nameCXHL2601327 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2026/10/29New drug · Class 1 | RGT-274-CR片 · No verified English nameCXHL2601326 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2026/10/29New drug · Class 1 | RGT-274-CR片 · No verified English nameCXHL2601325 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2026/10/28Import · Class 1 | ABBV-706注射用冻干粉 · No verified English nameJXSL2600289 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2026/10/28Import · Class 1 | AZD0486 · No verified English nameJXSL2600288 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/10/28Import · Class 1 | AZD0486 · No verified English nameJXSL2600287 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/10/28Import · Class 1 | AZD4512 · No verified English nameJXSL2600286 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/10/28Generic · Class 3 | 复方电解质维持液 · No verified English nameCYHS2602639 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized |
| 2026/10/28Generic · Class 3 | 复方电解质维持液 · No verified English nameCYHS2602638 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized |
| 2026/10/28New drug · Class 2.3 | 欣力康颗粒 · No verified English nameCXZL2600110 | Guiyang Xin Tian Pharma Co., Ltd. romanized |
| 2026/10/28New drug · Class 2.2 | 注射用瑞康曲妥珠单抗 · No verified English nameCXSS2600174 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Name not romanized |
| 2026/10/28New drug · Class 1 | 注射用GFS784 · No verified English nameCXSL2601185 | Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/10/28New drug · Class 1 | CG001注射液 · No verified English nameCXSL2601184 | Shanghai Kang Jing Biopharmaceuticals 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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