YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 259 drug applications between 23 October 2021 and 29 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 36, covering 28 drug names.
2021/10/23 – 2021/10/29
- New acceptances this week
- 259
- Drugs with new generic filings (by drug name, de-duplicated)
- 28
- 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
259filings, 36 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 138 |
| New drug | 42 |
| Generic | 36 |
| Import | 24 |
| Import re-registration | 15 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 185 |
| TCM | 39 |
| Therapeutic biologic | 29 |
| 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
28 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Moxifloxacin Hydrochloride And Sodium Chloride Injection | 2 | 2 | 10 |
| 2 | Olaparib Tablets | 2 | 1 | 0 |
| 3 | Levofloxacin Eye Drops | 2 | 1 | 16 |
| 4 | Torsemide Injection | 2 | 1 | 1 |
| 5 | Pregabalin Capsules | 2 | 1 | 12 |
| 6 | Lenvatinib Mesilate Capsules | 2 | 1 | 4 |
| 7 | Oxytocin Injection | 2 | 1 | 8 |
| 8 | 酒石酸伐尼克兰片 · No verified English name | 2 | 1 | 3 |
| 9 | Acetylcysteine Granules | 1 | 1 | 4 |
| 10 | Epalrestat Tablets | 1 | 1 | 1 |
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
148 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Sheng Yi Pu Bio Technology Co., Ltd. romanized | 9 | 9 | 0 |
| 2 | Dong E A Hua Medical Technology Co., Ltd. Pharma Branch romanized | 6 | 2 | 0 |
| 3 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Shaanxi Dong Ke Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | AstraZeneca AB | 5 | 3 | 0 |
| 6 | Hainan Jiu Chang Pharmaceutical Co., Ltd. romanized | 5 | 3 | 0 |
| 7 | H. Lundbeck A/S | 5 | 2 | 0 |
| 8 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized | 5 | 2 | 0 |
| 9 | Sanofi-Aventis Groupe | 5 | 1 | 0 |
| 10 | Boehringer Ingelheim International GmbH | 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
71 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/10/29Import · Class 3.1 | 纳武利尤单抗注射液 · No verified English nameJXSS2101028 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China)Investment Co. Ltd |
| 2021/10/29Import · Class 3.1 | 纳武利尤单抗注射液 · No verified English nameJXSS2101027 | Bristol-Myers Squibb Pharma EEIG; Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company; Bristol-Myers Squibb (China)Investment Co. Ltd |
| 2021/10/29Generic · Class 3 | Folic Acid TabletsCYHS2101949 | Zhejiang Bai Ao Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2021/10/29Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2101947 | Hebei Chuang Jian Pharma Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2021/10/29Generic · Class 3 | Epalrestat TabletsCYHS2101945 | Xian Wan Long Pharmaceutical Co., Ltd. romanized |
| 2021/10/29Generic · Class 3 | Clonidine hydrochloride extended-release tabletsCYHL2101033 | Shandong Da Yin Hai Yang Biopharmaceutical Co., Ltd. romanized |
| 2021/10/29New drug · Class 1 | PD-1基因定制活化T细胞注射液 · No verified English nameCXSL2101398 | Anhui Ke Dun Bio Technology Co., Ltd. romanized |
| 2021/10/29New drug · Class 1 | 注射用MRG003 · No verified English nameCXSL2101397 | Shanghai Mei Ya Ke Bio Technology Co., Ltd. romanized |
| 2021/10/29New drug · Class 2.1; 2.2 | 注射用RF16001 · No verified English nameCXHL2101621 | Beijing Hui Li Technology Co., Ltd. romanized; Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2021/10/29New drug · Class 1 | JMKX001899片 · No verified English nameCXHL2101620 | Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/10/29New drug · Class 1 | JMKX001899片 · No verified English nameCXHL2101619 | Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/10/29New drug · Class 2.4 | 盐酸米托蒽醌脂质体注射液 · No verified English nameCXHL2101618 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2021/10/28Import · Class 1 | MEDI3506注射液 · No verified English nameJXSL2101121 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2021/10/28Import · Class 2.2; 2.4 | IVIEW-1201 · No verified English nameJXHL2101225 | IVIEW Therapeutics, Inc.; Ai Wei Pharma (Zhuhai) Co., Ltd. romanized |
| 2021/10/28Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2101219 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2021/10/28Import · Class 2.4 | Osimertinib Mesylate TabletsJXHL2101218 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd |
| 2021/10/28New drug · Class 1 | GT101注射液 · No verified English nameCXSL2101394 | Suzhou Sha Li Bio Technology Co., Ltd. romanized |
| 2021/10/28New drug · Class 1 | D-1553片 · No verified English nameCXHL2101617 | Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized |
| 2021/10/28New drug · Class 1 | D-1553片 · No verified English nameCXHL2101616 | Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized |
| 2021/10/27Import · Class 1 | BI685509片 · No verified English nameJXHL2101224 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd |
| 2021/10/27Import · Class 1 | BI685509片 · No verified English nameJXHL2101223 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/10/27Import · Class 1 | BI685509片 · No verified English nameJXHL2101222 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/10/27Import · Class 2.4 | Tucatinib片 · No verified English nameJXHL2101221 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/10/27Import · Class 2.4 | Tucatinib片 · No verified English nameJXHL2101220 | Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD R&D (China) Co. Ltd. |
| 2021/10/27Generic · Class 3 | Levofloxacin InjectionCYHS2101934 | Jilin Si Huan Pharmaceutical Co., Ltd. romanized |
| 2021/10/27New drug · Class 1.1 | 和胃解毒胶囊 · No verified English nameCXZL2101031 | Changsha Xin Lin Pharmaceutical Co., Ltd. romanized |
| 2021/10/27New drug · Class 1 | 首克注利单抗注射液 · No verified English nameCXSS2101042 | Zhao Ke (Guangzhou) Zhong Liu Drug Co., Ltd. romanized; Wuxi Yao Ming Bio Technology Co., Ltd. romanized |
| 2021/10/27New drug · Class 1 | AK112注射液 · No verified English nameCXSL2101392 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/10/27New drug · Class 1 | AK117注射液 · No verified English nameCXSL2101391 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/10/27New drug · Class 2.2 | 注射用全氟丙烷人血白蛋白微球 · No verified English nameCXSL2101390 | Xiamen Li Zhuo Pharma Co., Ltd. romanized |
41 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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