YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 399 drug applications between 31 December 2025 and 6 January 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 95, covering 71 drug names.
2025/12/31 – 2026/01/06
- New acceptances this week
- 399
- Drugs with new generic filings (by drug name, de-duplicated)
- 71
- Accepted this week, now under review
- 118
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
399filings, 95 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 179 |
| Generic | 95 |
| New drug | 94 |
| Import | 19 |
| Unspecified | 11 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 234 |
| TCM | 83 |
| Therapeutic biologic | 72 |
| Biologic | 6 |
| Prophylactic biologic | 4 |
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
71 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 依伏卡塞片 · No verified English name | 4 | 2 | 9 |
| 2 | Bisoprolol Fumarate Tablets | 4 | 2 | 6 |
| 3 | Pregabalin Capsules | 3 | 1 | 12 |
| 4 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 5 | Levonorgestrel Tablets | 2 | 2 | 5 |
| 6 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 7 | Mupirocin Ointment | 2 | 2 | 30 |
| 8 | 西甲硅油乳剂 · No verified English name | 2 | 2 | 3 |
| 9 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
| 10 | 地氯雷他定口服溶液 · No verified English name | 2 | 1 | 26 |
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
234 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Nei Menggu Da Tang Pharma Co., Ltd. romanized | 14 | 14 | 0 |
| 2 | Sichuan Tian De Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Gan Li Pharma Shandong Co., Ltd. romanized | 9 | 1 | 0 |
| 4 | Novartis Pharma AG | 8 | 5 | 0 |
| 5 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 8 | 2 | 0 |
| 6 | Janssen-Cilag International NV | 8 | 1 | 0 |
| 7 | Guangdong Wan Nian Qing Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 8 | Heng Ji Pharmaceuticals (Shanghai) Co., Ltd. romanized | 6 | 1 | 0 |
| 9 | Nanjing Rui Chu Pharmaceuticals Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Beijing Foyou Pharma CO.,LTD | 4 | 4 | 3 |
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
133 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/01/06Import · Class 1 | 177Lu-PSMA I&T注射液 · No verified English nameJXHL2600006 | Curium US LLC; Beijing Regitrans Consulting Co. Ltd. |
| 2026/01/06Import · Class 2.4 | ABL001片 · No verified English nameJXHL2600005 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/01/06Import · Class 2.4 | ABL001胶囊装颗粒 · No verified English nameJXHL2600004 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/01/06Import · Class 2.4 | ABL001胶囊装颗粒 · No verified English nameJXHL2600003 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/01/06Import · Class 2.4 | ABL001胶囊装颗粒 · No verified English nameJXHL2600002 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/01/06Generic · Class 3 | Promethazine Hydrochloride InjectionCYHS2600044 | Kang Pu Pharma Co., Ltd. romanized |
| 2026/01/06Generic · Class 3 | Promethazine Hydrochloride InjectionCYHS2600043 | Kang Pu Pharma Co., Ltd. romanized |
| 2026/01/06Generic · Class 3 | Nalbuphine Hydrochloride InjectionCYHS2600037 | Guo Yao Group Gong Ye Co., Ltd. Lang Fang Branch romanized |
| 2026/01/06Generic · Class 3 | 利非司特滴眼液 · No verified English nameCYHL2600003 | Chengdu Tian Xing Zhi Yuan Bio Technology Co., Ltd. romanized |
| 2026/01/06Generic · Class 3 | Relugolix TabletsCYHL2600002 | Shandong Fu Rui Da Pharmaceuticals Group Co., Ltd. romanized |
| 2026/01/06New drug · Class 3.1 | 一贯煎颗粒 · No verified English nameCXZS2600001 | Anhui Hua Run Jin Chan Pharma Co., Ltd. romanized |
| 2026/01/06New drug · Class 1.1 | 消炎解毒合剂 · No verified English nameCXZL2600001 | Hubei Yi En Pharma Co., Ltd. romanized |
| 2026/01/06New drug · Class 3.4 | 人凝血酶原复合物 · No verified English nameCXSS2600001 | Guo Yao Group Guizhou Biopharmaceutical Co., Ltd. romanized |
| 2026/01/06New drug · Class 1 | SSGJ-716注射液 · No verified English nameCXSL2600014 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2026/01/06New drug · Class 3.2 | 抗D人免疫球蛋白 · No verified English nameCXSL2600013 | Xinjiang De Yuan Bio Gong Cheng Co., Ltd. romanized |
| 2026/01/06New drug · Class 1 | 注射用RGL-236 · No verified English nameCXSL2600012 | Shanghai Rui Hong Di Pharmaceuticals Co., Ltd. romanized; Guangzhou Rui Ling Pharmaceuticals Co., Ltd. romanized |
| 2026/01/06New drug · Class 3.3 | PJ021注射液 · No verified English nameCXSL2600010 | Chongqing Pai Jin Bio Technology Co., Ltd. romanized |
| 2026/01/06New drug · Class 1 | 注射用IMM0306 · No verified English nameCXSL2600009 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/01/06New drug · Class 3.3 | JMT205注射液 · No verified English nameCXSL2600008 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2026/01/06New drug · Class 1 | SSS55注射液 · No verified English nameCXSL2600007 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/01/06New drug · Class 1 | HSK39297片 · No verified English nameCXHS2600002 | Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized; Hai Si Ke Pharmaceutical (Mei Shan) Co., Ltd. romanized |
| 2026/01/06New drug · Class 2.3 | 缬沙坦左氨氯地平片 · No verified English nameCXHS2600001 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Jiangsu He Chen Pharma Co., Ltd. romanized |
| 2026/01/06New drug · Class 1 | SYH2082注射液 · No verified English nameCXHL2600019 | Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2026/01/06New drug · Class 1 | SYH2082注射液 · No verified English nameCXHL2600018 | Beijing Kang Chuang Lian Biopharmaceutical Technology Research Co., Ltd. romanized; CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2026/01/06New drug · Class 1 | NTQ6179片 · No verified English nameCXHL2600015 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.; Zhongguo Yao Ke University romanized |
| 2026/01/06New drug · Class 1 | NTQ6179片 · No verified English nameCXHL2600014 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.; Zhongguo Yao Ke University romanized |
| 2026/01/06New drug · Class 1 | NTQ6179片 · No verified English nameCXHL2600013 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.; Zhongguo Yao Ke University romanized |
| 2026/01/06New drug · Class 2.3 | H008AMX片 · No verified English nameCXHL2600012 | Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized |
| 2026/01/05Import · Class 2.1 | 仑卡奈单抗注射液(皮下注射) · No verified English nameJXSS2600001 | Eisai Inc.; Terumo Corporation Kofu Factory; Eisai China Inc. |
| 2026/01/05Import · Class 2.1 | 注射用贝林妥欧单抗(皮下注射) · No verified English nameJXSL2600001 | Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd. |
103 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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