YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 246 drug applications between 22 November 2021 and 28 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 35, covering 25 drug names.
2021/11/22 – 2021/11/28
- New acceptances this week
- 246
- Drugs with new generic filings (by drug name, de-duplicated)
- 25
- Accepted this week, now under review
- 0
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
246filings, 35 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 130 |
| Generic | 35 |
| New drug | 35 |
| Import | 29 |
| Unspecified | 14 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 176 |
| Therapeutic biologic | 38 |
| TCM | 24 |
| Prophylactic biologic | 5 |
| Biologic | 3 |
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
25 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Temozolomide Capsules | 3 | 1 | 0 |
| 2 | Dexmedetomidine Hydrochloride Injection | 3 | 1 | 1 |
| 3 | Moxifloxacin Hydrochloride Eye Drops | 2 | 2 | 4 |
| 4 | Tadalafil Tablets | 2 | 1 | 23 |
| 5 | Obeticholic Acid Tablets | 2 | 1 | 0 |
| 6 | Fluorouracil Injection | 2 | 1 | 6 |
| 7 | Dexmedetomidine Hydrochloride Injection | 2 | 1 | 0 |
| 8 | Aprepitant Capsules | 2 | 1 | 0 |
| 9 | Rivaroxaban Tablets | 1 | 1 | 3 |
| 10 | 卡格列净二甲双胍缓释片 · No verified English name | 1 | 1 | 5 |
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
143 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized | 13 | 13 | 0 |
| 2 | Wuhan Ai Min Pharmaceutical Co., Ltd. romanized | 9 | 9 | 0 |
| 3 | Actelion Pharmaceuticals Ltd | 8 | 1 | 0 |
| 4 | Hainan Tao Sheng Pharmaceuticals Technology Research Institute Co., Ltd. romanized | 7 | 4 | 0 |
| 5 | Pan Shi Ju Kang Pharma Co., Ltd. romanized | 5 | 4 | 0 |
| 6 | Sichuan Guo Rui Pharma Co., Ltd. romanized | 5 | 2 | 5 |
| 7 | F. Hoffmann-La Roche Ltd | 4 | 3 | 0 |
| 8 | ViiV Healthcare BV | 4 | 3 | 0 |
| 9 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized | 4 | 3 | 4 |
| 10 | AstraZeneca AB | 4 | 2 | 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
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
69 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/11/26Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSS2101033 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd |
| 2021/11/26Import · Class 1 | HBM9161(HL161BKN)注射液 · No verified English nameJXSL2101139 | Harbour BioMed Therapeutics Limited; He Bo Pharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/11/26Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2101261 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2021/11/26Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2101260 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2021/11/26New drug · Class 1.2 | 丹酚酸A · No verified English nameCXZL2101035 | Jiangxi Qing Feng Pharma Co., Ltd. romanized |
| 2021/11/26New drug · Class 1 | SI-B003双特异性抗体注射液 · No verified English nameCXSL2101452 | Sichuan Bai Li Pharma Co., Ltd. romanized; Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized |
| 2021/11/26New drug · Class 1 | SI-B003双特异性抗体注射液 · No verified English nameCXSL2101451 | Sichuan Bai Li Pharma Co., Ltd. romanized; Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized |
| 2021/11/26New drug · Class 1 | KN052注射液 · No verified English nameCXSL2101450 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2021/11/26New drug · Class 1 | PM1022 注射液 · No verified English nameCXSL2101447 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2021/11/26New drug · Class 1 | 重组抗IL-4Rα单域抗体雾化液(毕赤酵母) · No verified English nameCXSL2101446 | Shanghai Luo Qi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/26New drug · Class 1 | ES002023注射液 · No verified English nameCXSL2101445 | Ke Wang (Suzhou) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/26New drug · Class 1 | 硝酮嗪肠溶片 · No verified English nameCXHL2101688 | Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized |
| 2021/11/26New drug · Class 1 | 硝酮嗪肠溶片 · No verified English nameCXHL2101687 | Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized |
| 2021/11/26New drug · Class 2.1 | MBT-1608片 · No verified English nameCXHL2101683 | Beijing SL Pharmaceutical Co., Ltd. |
| 2021/11/25Generic · Class 3 | Levofloxacin InjectionCYHS2102083 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD. |
| 2021/11/25Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2102064 | Sichuan Guo Rui Pharma Co., Ltd. romanized |
| 2021/11/25New drug · Class 1.2 | 注射用丹酚酸A · No verified English nameCXZL2101034 | Jiangxi Qing Feng Pharma Co., Ltd. romanized |
| 2021/11/25New drug · Class 1 | WJ05129片 · No verified English nameCXHL2101686 | Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/25New drug · Class 1 | WJ05129片 · No verified English nameCXHL2101685 | Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/11/24Import · Class 2.2 | 纳武利尤单抗注射液 · No verified English nameJXSL2101138 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2021/11/24Import · Class 1 | NKTR-214 · No verified English nameJXSL2101137 | Nektar Therapeutics; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2021/11/24Import · Class 1 | NKTR-214 · No verified English nameJXSL2101136 | Nektar Therapeutics; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2021/11/24Import · Class 2.3; 2.4 | CARDIX-101胶囊 · No verified English nameJXHL2101254 | CARDIX THERAPEUTICS LLC; SHANGHAI GENOMICS INC |
| 2021/11/24Import · Class 2.3; 2.4 | CARDIX-101胶囊 · No verified English nameJXHL2101253 | CARDIX THERAPEUTICS LLC; SHANGHAI GENOMICS INC |
| 2021/11/24Import · Class 2.3 | CARDIX-101胶囊 · No verified English nameJXHL2101252 | CARDIX THERAPEUTICS LLC; SHANGHAI GENOMICS INC |
| 2021/11/24Generic · Class 3 | Sumatriptan and Naproxen Sodium TabletsCYHS2102076 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2021/11/24Generic · Class 3 | Fluorouracil InjectionCYHS2102075 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2021/11/24Generic · Class 3 | Fluorouracil InjectionCYHS2102074 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2021/11/24New drug · Class 1 | 自体自然杀伤细胞注射液 · No verified English nameCXSL2101444 | Guangzhou Da Bo Bio Zhi Pin Co., Ltd. romanized |
| 2021/11/24New drug · Class 1 | CAStem细胞注射液 · No verified English nameCXSL2101443 | Beijing Ze Hui Chen Xing Bio Technology Co., Ltd. romanized |
39 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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